Clinical study to assess efficacy and safety of Purifying Neem Face Wash in prevention and reduction of acne in healthy adults

Abstract

Background

Acne vulgaris is a chronic, inflammatory skin condition of pilosebaceous units. The standard treatment involves topical and oral antibiotics, retinoids, benzoyl peroxide, and other synthetic compounds, mostly associated with adverse effects. Hence, herbal skincare products are considered nowadays.

Aim

To evaluate the safety and efficacy of Purifying Neem Face Wash (PNFW), an herbal skincare product in the prevention and/or reduction of mild‐to‐moderate acne.

Methods

An open‐label, single‐center, single‐arm, four‐week clinical study was conducted with subjects having either mild‐to‐moderate acne or oily skin and non‐existent acne. The performance of PNFW in the reduction and/or prevention of acne was detected by counting cutaneous inflammatory and non‐inflammatory acne lesions in each of the four visits. Sebum level and skin hydration of both cheeks were measured via sebumeter and corneometer, respectively. Self‐assessment questionnaires were used to assess the subjects’ responses toward PNFW.

Results

Out of 120 study subjects, 79% and 72% showed either reduction or no new appearance of inflammatory and non‐inflammatory acne lesions, respectively, from baseline to Visits 3 and 4. Skin sebum level and skin hydration showed a statistically significant decrease (p < 0.001) and increase (p < 0.001), respectively, in Visits 3 and 4. Self‐assessment surveys showed the satisfaction of the subjects about the product in terms of condition improvement, ease in use, and fragrance.

Conclusion

The present study indicated the beneficial effect of the herbal ingredients (neem and turmeric) of Himalaya's PNFW in the prevention and reduction of mild‐to‐moderate acne with no side effects.

1. INTRODUCTION

Acne vulgaris is a chronic inflammatory dermatosis of pilosebaceous unit (composed of the hair follicle, hair shaft, and sebaceous gland) and the most common skin condition globally (approximately 650 million people). ¹ , ² , ³ , ⁴ In 2010, a systematic analysis for the Global Burden of Disease study reported acne as the eighth most prevalent disease worldwide. ⁵ Acne is characterized by non‐inflammatory, superficial, open comedones (blackheads) or closed comedones (whiteheads), inflammatory deeper lesions (such as papules, pustules, nodules, and cysts), and secondary lesion including various degrees of scarring and dark marks from old acne. ³ , ⁶ , ⁷  The severity of acne has been classified as mild, moderate, or severe based on the extent and types of lesions. ⁸ Although the occurrence of acne is highest among the teenagers with an estimated prevalence of >95% in teenage boys and 85% in teenage girls. However, a considerable number of men and women (50%) continue to have acne in the adulthood. ¹ , ² , ³

The acne vulgaris mostly originate in the pilosebaceous follicles. ⁸ Acne is associated with the blockages in the skin follicles and most commonly occurs on the face where the maximum number of pilosebaceous units are present. ² , ⁹ , ¹⁰  Pathogenesis of acne vulgaris is involved in the four inter‐related process including inflammation, abnormal shedding of follicular epithelium, follicular colonization by Cutibacterium acnes (previously called Propionibacterium acnes [P. acnes]), and sebum overproduction. The overproduction of sebum can be caused either by high levels of androgen hormones or by increased sensitivity of sebaceous gland to the normal levels of androgen hormones. ⁸  The normal functioning of the pilosebaceous unit is damaged by these inter‐related processes, thereby leading to the transition of a normal pore to microcomedones, and additionally to comedones and inflammatory lesions. However, circulating sex hormone and other locally produced hormones (like pro‐inflammatory cytokines, lipid mediators, neuropeptides, microbiota, monounsaturated fatty acids, and antimicrobial peptides) can control these inter‐related processes. ¹

Various studies conducted on heterozygous and homozygous twins and their families, reported a relationship between their hereditary factors and the risk of acne development. ¹¹ , ¹² , ¹³ Such studies confirm the genetic component of acne. ⁸

The severity of acne can be affected with certain foods with high glycemic index (sugary drinks, starchy foods, highly processed foods) and drinks like skim milk. Tobacco smoke, ultraviolet radiation, psychological stress, modern lifestyle, and damaged or unhealthy skin are the certain other factors that may be involved in the growth and development of acne. ¹ , ⁸

For the management of acne vulgaris, a multifactorial approach is followed with various treatment options targeted toward different factors associated with its pathophysiology. According to the American Academy of Dermatology/American Academy of Dermatology Association, the treatment options for acne vulgaris are as follows:

1. Topical therapies: benzoyl peroxide, topical antibiotics (eg, clindamycin and erythromycin), topical retinoids (eg, tretinoin, adapalene, and tazarotene), azelaic acid, dapsone, and salicylic acid.

2. Systemic antibiotics: tetracyclines (eg, tetracycline, doxycycline, and minocycline), macrolides (eg, azithromycin and erythromycin), and trimethoprim (with or without sulfamethoxazole).

3. Hormonal agents: combined oral contraceptives, spironolactone, flutamide, and oral corticosteroids.

4. Isotretinoin.

5. Miscellaneous therapies and physical modalities: chemical peels and intralesional steroids.

6. Complementary and alternative therapies (eg, tea tree oil, herbal, and biofeedback).

Studies suggested that the first‐line treatment for mild acne vulgaris is benzoyl peroxide or a topical retinoid, or a combination of topical medications including topical antibiotics. The preferred systemic antibiotics for the treatment of acne vulgaris were tetracyclines; however, clinical data suggested that minocycline and doxycycline showed more effectiveness compared to tetracyclines. ¹⁴  Topical and systemic antibiotic is in the center of antimicrobial treatment of acne. Moreover, salicylic acid, alpha‐hydroxy acids, and retinoids treat acne with different mechanisms of action. Favorable outcomes are obtained by combining the alpha‐hydroxy acid‐induced exfoliation in hydrophilic areas, retinoid‐induced normalization of cellular differentiation, and salicylic acid‐induced exfoliation in lipophilic areas. ¹⁵

Intensive use of antibiotics for a longer duration leads to the increased resistance in acne causing bacteria, that is, P. acnes, S. epidermidis, and S. aureus. ¹⁰ , ¹⁶ In addition, allopathic medications for acne may be toxic for body tissue and biological activities of the body. ¹⁷  They are often associated with several other side effects, such as contact allergy, local irritation, scaling, pruritis, redness, itching, skin peeling, and photosensitivity, leading to poor medication adherence and treatment failure. ¹⁰ , ¹⁸  Therefore, to overcome the underlying issues, products with herbal ingredients that would avoid the side effects of the synthetic ingredients become essential and have been extensively studied as alternative treatments for acne vulgaris. ¹⁰ , ¹⁶

Ayurveda uses herbs containing natural phytoconstituents to make the skincare products that protect the skin from external effects without causing any adverse effects. ¹⁹ Several natural herbal sources such as neem, aloe, tulsi, amla, papaya, ginger, and eucalyptus are found to be safe and effective in treating different skin‐related infections. ²⁰  Multiple skincare and cosmetic products of herbal formulations are reported to be considerably effective in reducing acne vulgaris. The three main properties of herbal products include antioxidants, smoothing, and moisturizing property. The antioxidant components will inhibit aging and inflammatory effects of skin by diminishing the presence of free radicals. Similarly, the moisturizing property will impart cooling effect together with improved skin smoothness. It also focuses on repairing the epidermal barrier to reduce trans epidermal water loss and prevent the skin from dehydrating. ²¹ Additionally, these herbal products can control sebum secretion, have antibiotic and keratolytic effects, have fewer side effects, and better tolerance than modern synthetic products. ² , ²¹  Neem (Azadirachta indica) is an excellent herbal skincare ingredient as it has antimicrobial and anti‐inflammatory properties, as well as the ability to support the immune system. ¹⁷ , ²² It can fight with bacteria to prevent the recurrence of acne lesions and makes the skin healthy. ²² , ²³ Another well‐known natural ingredient used as a herbal remedy for skin is turmeric (Curcuma longa). Curcumin, a natural polyphenolic pigment present in turmeric, has strong anti‐inflammatory, antimicrobial, and anti‐oxidative properties to control skin infection caused by P. acnes and S. epidermidis and considered to be ideal to reduce skin problems such as acne. ²⁴

Further, it is believed that acne has a correlation with poor hygiene condition and therefore, use of proper cleansing regimen is recommended for acne vulgaris patients. Mild, gentle cleansers with surface‐active emulsifiers that may remove dirt, bacteria, sebum, and corneocytes without making the skin dry, are considered to have better effect on the skin of acne patients. ²⁵

Himalaya's Purifying Neem Face Wash (PNFW), an Ayurvedic proprietary product made of neem and turmeric, is meant to address common/routine facial skin problems. PNFW is a well‐known product with soap‐free formulation along with extra beneficial properties of herbs that help to prevent/reduce acne. This study aimed to evaluate the safety and efficacy of PNFW in the prevention and/or reduction of inflammatory and non‐inflammatory acne lesions in healthy adult volunteers under the supervision of dermatologists, to imbibe more confidence about the promising product among the consumers.

2. MATERIALS AND METHODS

2.1. Study design and ethical considerations

An open‐label, single‐center, single‐arm, clinical study of four weeks’ duration was conducted from February 1, 2019 to April 1, 2019 in Cliantha Research at Ahmedabad, Gujarat, India to evaluate the efficacy and safety of PNFW. The study was performed according to the declaration of Helsinki, ethical principles for medical research involving human subjects, statutory provisions prescribed under Drugs and Cosmetic Rules, 1945, ethical guidelines for biomedical research 2006 by the Indian Council of Medical Research (ICMR), and principles of Good Clinical Practice (GCP) as well as Indian GCP. Independent ethics committee (IEC) reviewed and approved the protocol prior to the commencement of the study. All subjects who agreed to participate in the study, provided voluntary acceptance and signed an informed consent form prior to the study‐related procedures.

2.2. Study product

Purifying Neem Face wash (PNFW) is a combination of extracts of neem and turmeric with mild surfactants comprising of anionic and amphoteric nature. PNFW is a soap free, lipid free, pH balanced cleanser, which as per dermatological recommendations, is an ideal formulation for acne‐prone skin. ²⁶ , ²⁷ Soap‐based formulations have pH in alkaline range which will strip off skin's natural lipids and cause irritation to sensitive skin. It is preferred to use low pH cleansing systems in individuals with dry skin, pre‐disposition to acne vulgaris, and seborrhoea. ²⁸ , ²⁹  The combination of anionic, amphoteric, and non‐ionic surfactants results in association of amphiphile monomers in larger aggregates due to their steric interaction. This makes a cleanser with mixed micellar combination effectively remove the dirt and grime while remain gentle and mild on skin. ³⁰ , ³¹ , ³²

2.3. Study population

Two groups of subjects based on acne characteristics were enrolled in this study. They were subjects with existing mild‐to‐moderate level of acne and subjects with oily skin but non‐existing acne. Inclusion criteria of the study were as follows: (i) healthy males or non‐pregnant/non‐lactating females of age between 18 and 30 years with mild‐to‐moderate acne or subjects of age between 18 and 25 years with non‐existing acne but prone to develop acne, (ii) subjects with mild‐to‐moderate acne condition [Grade 2 to 3 as per United States Food and Drug Administration Guideline, Investigator's Global Assessment (IGA) scale for acne severity ³³ ] with oily facial skin and sebum level of cheek ≥150 µg/cm² (obtained via sebumeter), (iii) subjects willing to have a wash out of usual cosmetic product three days before the study began and willing to follow their normal skincare routines and abstain from using any cosmetic product (such as facial soap, cleansers, lotions, and creams) on face and also not willing to use any new facial skincare products except the provided products during the study period, (iv) subjects without any known allergy/sensitivity to cosmetic products or fragrance and without any skin allergies/infections, subjects not under any dermatologic treatment/infections, and (v) subjects willing to visit the site at specified frequencies for periodic evaluations and agree to comply with study specific requirements. Exclusion criteria were as follows: (i) subjects with a known history of allergy or sensitivity to neem or other cosmetic products or having any active dermatological skin diseases (such as atopic dermatitis, rosacea, and psoriasis), (ii) subjects unwilling to avoid unprotected sun or other ultraviolet radiation (UV) exposure during the study period, (iii) subjects participating in any other similar clinical study or test panel within one month before the entry into the study, (iv) subjects receiving steroids or antihistamine medications or receiving isotretinoin for treating other conditions, (v) subjects using corticosteroids, contraceptives, dilantin, flutamide, or testosterone, subjects diagnosed with an endocrinologic disorder likely to cause acne, and (vi) subjects with a history of drug and/or alcohol abuse.

2.4. Study procedures

Potential subjects were screened according to the inclusion and exclusion criteria. Eligible candidates received PNFW for four weeks (28 days). Subjects were instructed to moisten their face and then to apply a coin size (3 ml) PNFW and gently work up a lather using a circular motion, followed by washing off the product and drying the face by patting. This was required to be done twice daily. The schedule of the study is described in Figure 1. The study included four visits: Visit 1 was the screening visit (within 30 days prior to Day 1), Visit 2 was the enrollment (Day 1), Visit 3 was the evaluation phase (Day 14 ± 2 days), and Visit 4 was the evaluation/end of the study (Day 28 ± 2 days).

FIGURE 1.

Schematic representation of the study procedure [Color figure can be viewed at wileyonlinelibrary.com]

Instrumental assessment via sebumeter and corneometer, and subject self‐evaluation assessment using questionnaires were conducted for efficacy evaluation. Safety was assessed throughout the study by monitoring adverse events (AEs).

2.5. Study endpoints

2.5.1. Primary endpoint

The primary endpoint of this study was the performance of the PNFW with respect to the outbreak of acne based on the determination of new appearance and prevention of inflammatory and non‐inflammatory acne lesions. This was assessed by dermatologists using the IGA scale for acne severity ³³ (Table 1) and also by counting inflammatory and non‐inflammatory cutaneous acne lesions on facial areas from baseline, that is, Day 1 before application to Day 14 and Day 28 after application.

TABLE 1.

Investigator's Global Assessment (IGA) Scale for acne severity

Grade	Description
Grade 0	Clear skin with no inflammatory or non‐inflammatory lesions
Grade 1	Almost clear, rare non‐inflammatory lesions with no more than 1 small inflammatory lesion
Grade 2	Mild severity; greater than grade 1; some non‐inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
Grade 3	Moderate severity; greater than grade 2; up to many non‐inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesions
Grade 4	Severe; greater than grade 3; up to many non‐inflammatory and inflammatory lesions, but no more than a few nodular lesions.

2.5.2. Secondary endpoints

Secondary endpoints of the study included the following: (i) reduction of inflammatory and non‐inflammatory acne lesions assessed by using the IGA scale for acne severity and also by counting cutaneous acne lesions change from baseline (Day 1 before application) to Day 14 and Day 28 after application of the product, (ii) the effect of PNFW on skin sebum level by measuring sebum level via Sebumeter® SM 815 on Day 1, Day 14, and Day 28, (iii) the effect of PNFW on skin hydration change from Day 1 to Day 14 and Day 28 as measured via Corneometer® CM 825, (iv) the efficacy and cosmetic attributes of PNFW based on Subject self‐evaluation questionnaire according to 4‐point scale (0 = no improvement, 1 = minimal improvement, 2 = moderate improvement, 3 = marked improvement) recorded by subjects on Day 14 and Day 28 after application, and (v) assessment of subject's response index (consumer perception about product) toward PNFW using self‐assessment questionnaire asked and filled by study personnel on Day 14 and Day 28 after application.

2.6. Statistical analyses

Using nQuery software, when the evaluable sample size is 96, two‐sided 95% confidence interval of the proportion of subjects stop or prevent acne from baseline with a range from 72 to 90%, using the large sample normal approximation with the expected proportion of 80% and 8% margin of error. In other words, it was determined that at least a 72% response was enough to prove the efficacy of the product in a predefined population. After accounting for 20% attrition, a total of 120 subjects were sufficient to meet study objectives.

For continuous variables, the within‐treatment analyses were conducted to compare baseline to post‐treatment data using a paired t test. For categorical variables, the frequency and percentage of each category were provided. An appropriate analysis using a non‐parametric test was carried out. For continuous data, descriptive statistics (mean, standard error, median, minimum, and maximum) were used. All statistical analyses were done using SAS statistical software (version: 9.4; SAS Institute Inc., USA), with 5% level of significance.

3. RESULTS

3.1. Demographic characteristics of the subjects

A total of 178 subjects were screened based on the presence of mild‐to‐moderate acne or without acne but prone to develop it. Among them, 58 (32.58%) failed the screening, and 120 (67.42%) were enrolled in the study. Of these 120 subjects, 73 (60.83%) had acne and 47 (39.17%) were prone to develop acne at the time of enrollment. Among 120 enrolled subjects, 108 (90%) completed the study and 12 (10%) were discontinued due to loss of follow‐up. There were 64 (53%) males and 56 (47%) females. The average age of the subjects was 22.7 years at the time of screening visits (Table 2).

TABLE 2.

Demographic characteristics of the study subjects

Summary of Demographic Characteristics of All Subjects (N= 120)
Age (Years)	Mean ± SD	22.7 ± 3.52
Gender, n (%)	Male	64 (53%)
	Female	56 (47%)
Race, n (%)	Asian	120 (100%)

Abbreviations: n, number of subjects in each category; N, Total number of subjects in the study; SD, standard deviation.

3.2. Primary endpoint assessment (Proportion of subjects showing prevention of acne)

3.2.1. Measurement of acne vulgaris for inflammatory and non‐inflammatory acne lesions

Out of 108 subjects completing the study, 49 (45.37%) showed a reduction in number of inflammatory lesions and 36 (33.33%) did not show the appearance of any inflammatory acne lesion from baseline to Day 28. Therefore, a total of 85 subjects (78.70%) revealed either reduction or no new inflammatory acne lesions from baseline to Day 28 (Figure 2). Among 108 subjects, 74 (68.51%) showed a reduction in the number of lesions from baseline to Day 28, and in four (3.70%) subjects, no new acne appeared from baseline to Day 28. Hence, a total of 78 subjects (72.22%) showed either reduction or no new appearance of non‐inflammatory acne lesions from baseline to Day 28 (Figure 2).

FIGURE 2.

Measurement of acne vulgaris in the subjects for (A) inflammatory lesions, (B) non‐inflammatory lesions [Color figure can be viewed at wileyonlinelibrary.com]

3.3. Secondary endpoint assessment

3.3.1. Reduction in acne lesion

As assessed by the IGA scale of acne severity and counting of acne lesions change from Day 1 (baseline), Day 14 (Visit 3), and to Day 28 (Visit 4) after application of the product, the number of both inflammatory and non‐inflammatory acne lesions showed a reduction. From baseline to Visit 3, the percentages of reduction of cutaneous inflammatory and non‐inflammatory acne lesions were 31.81 and 18.48, respectively, and for Visit 4, the reduction percentages were 39.13 and 21.80, respectively (Figure 3).

FIGURE 3.

Graphical representation of acne lesions: (A) Inflammatory lesions, (B) Non‐inflammatory lesions [Color figure can be viewed at wileyonlinelibrary.com]

There is a statistically significant reduction observed in inflammatory acne lesion at Visit 3 (p < 0.003) and Visit 4 (p < 0.001) on the face, which clinically indicates the significant reduction in cutaneous inflammatory acne lesions at Visit 3 and Visit 4 as compared to the baseline. Moreover, a statistically significant reduction was observed in non‐inflammatory acne lesions at Visit 3 (p < 0.001) and Visit 4 (p < 0.001), clinically indicating the significant reduction in cutaneous non‐inflammatory acne lesions at Visits 3 and 4 in comparison to the baseline.

3.3.2. Sebum level evaluation (Sebumeter)

There was a statistically significant reduction in skin sebum level on both cheeks of the subjects at Visit 3 (p < 0.001) and Visit 4 (p < 0.001) (Figure 4) signifying the prevention of recurrence of lesions.

FIGURE 4.

Graphical representation of sebumeter evaluation of (A) Left Cheek, (B) Right Cheek [Color figure can be viewed at wileyonlinelibrary.com]

3.3.3. Skin hydration evaluation (Corneometer)

A statistically significant increase in skin hydration was observed in both cheeks of the subjects at Visit 3 (p < 0.001) and Visit 4 (p < 0.001) (Figure 5) suggesting that the test product did not cause dryness of the face.

FIGURE 5.

Graphical representation for corneometer evaluation of (A) Left Cheek, (B) Right Cheek [Color figure can be viewed at wileyonlinelibrary.com]

3.3.4. Subject self‐evaluation questionnaire

Performance of PNFW based on efficacy and cosmetic attributes was evaluated via Subject self‐evaluation questionnaire on Day 14 and Day 28. For most of the questions asked, the majority of the subjects responded: “moderate improvement” of acne condition at Day 14 and “marked improvement” of acne condition on Day 28 (Table 3).

TABLE 3.

Summary of test product performance

Subject self‐evaluation questionnaire: Question	Visits	Responses (%)
		No improvement	Minimal improvement	Moderate improvement	Marked improvement
Does this product reduce pimple marks	Visit 03 (Day 14)	–	4.21	91.58	4.21
	Visit 04 (Day 28)	–	–	70.37	29.63
Does dark spot are less visible?	Visit 03 (Day 14)	–	5.26	91.58	3.16
	Visit 04 (Day 28)	–	–	69.44	30.56
Do the marks leave by pimples are less visible?	Visit 03 (Day 14)	–	4.21	93.68	2.11
	Visit 04 (Day 28)	–	–	72.22	27.78
Does this product reduce redness from my skin?	Visit 03 (Day 14)	–	6.32	91.58	2.11
	Visit 04 (Day 28)	–	0.93	78.7	20.37
Does this product reduce oil from my skin?	Visit 03 (Day 14)	–	2.11	90.53	7.37
	Visit 04 (Day 28)	–	–	32.41	67.59
Does this product reduce pimples from my skin?	Visit 03 (Day 14)	–	7.37	88.42	4.21
	Visit 04 (Day 28)	–	0.93	45.37	53.70
Does skin remain fresh throughout the day?	Visit 03 (Day 14)	–	2.11	60.00	37.89
	Visit 04 (Day 28)	–	–	26.85	73.15
Does this product prevent pimple recurrence?	Visit 03 (Day 14)	1.05	9.47	78.95	10.53
	Visit 04 (Day 28)	–	–	38.89	61.11
Does this product make skin dry or stretchy?	Visit 03 (Day 14)	78.95	10.53	9.47	1.05
	Visit 04 (Day 28)	85.19	8.33	5.56	0.93
Does this product keep skin protect from skin problems?	Visit 03 (Day 14)	–	6.32	89.47	4.21
	Visit 04 (Day 28)	–	–	34.26	65.74

3.3.5. Subjects’ Response Index and response for product fragrance

Subjects’ response index (consumer perception about the product) on Day 14 and Day 28 after application of PNFW was evaluated using a 5‐scale questionnaire form. More than 90% of the subjects agreed that they were satisfied with the product in terms of hygiene, skin smoothening, reduction of skin dryness, and suitability to the skin (Table 4). Subjects’ response toward product fragrance was evaluated for Visits 3 and 4 with a 3‐point scale (unpleasant, good, and pleasant). About 88.42% and 99.07% reported a pleasant smell at Visits 3 and 4, respectively (Table 5).

TABLE 4.

Summary of subject response index

Question	Visits	Response (%)
		Strongly disagree	Disagree	Neither agree nor disagree	Agree	Strongly agree
Do you feel hygienic after application of the product?	Visit 03 (Day 14)	–	3.16	–	93.68	3.16
	Visit 04 (Day 28)	–	–	–	97.22	2.78
Does the product smoothening without dryness?	Visit 03 (Day 14)	–	–	2.11	91.58	6.32
	Visit 04 (Day 28)	–	–	–	97.22	2.78
Does the product cleansing without dryness?	Visit 03 (Day 14)	–	1.05	2.11	90.53	6.32
	Visit 04 (Day 28)	–	0.93	–	95.37	3.70
Does this product suits to skin?	Visit 03 (Day 14)	–	–	3.16	91.58	5.26
	Visit 04 (Day 28)	–	–	–	95.37	4.63

TABLE 5.

Summary of subject response for product fragrance

Question	Visits	Unpleasant	Good	Pleasant
Does the product have appealing fragrance?	Visit 03 (Day 14)	1.05%	10.53%	88.42%
	Visit 04 (Day 28)	–	0.93%	99.07%

3.4. Safety evaluation

No serious AEs related to PNFW were reported or recorded during this study. There was also no discontinuation of the product or drop out of any subject due to AE or any other safety issue.

4. DISCUSSION

Acne vulgaris is an extremely common skin problem that affects majority of the individual once in their lifetime. ² , ³ , ¹⁰ Acne mostly affects the face, which in turn affects the general quality of life (QoL) of the person including self‐esteem and emotions, and in extreme cases, the problem of QoL could be compared with some chronic general medical conditions such as asthma, diabetes, and back pain. ⁷ Due to a significant cutaneous and psychological burden, acne needs prompt treatment. ³⁴  With a better understanding of the multifactorial pathogenesis of acne, new treatment modalities targeted toward different causative factors of acne have been developed. ³⁴ , ³⁵ , ³⁶ Effective management of acne requires judicious selection of anti‐acne agents based on the clinical presentation and individual patient needs. ³⁵

The development of inflammatory acne lesions is mostly associated with the colonization of P. acnes, which can activate complements and metabolize sebaceous triglycerides into fatty acids. Moreover, S. epidermidis and S. aureus are typically responsible for infections in the pilosebaceous unit. ¹⁰  The destruction of these microorganisms is the main focus of acne treatment for which antibiotics are extensively used. ¹⁰ , ¹⁶  The prolonged use of antibiotics resulted in increased antibiotic resistance due to which herbal products from the medicinal plants are nowadays used as an alternative mode to reduce or prevent acne. ¹⁰ , ¹⁸

Himalaya's PNFW is an Ayurvedic proprietary skincare product that contains neem and turmeric Both neem and turmeric have antimicrobial, antibacterial, and anti‐inflammatory properties, which can fight against P. acnes and S. epidermidis that excrete pro‐inflammatory cytokines such as tumor necrosis factor α, interleukin (IL)‐1a, IL‐B leading to acne. ¹⁰ , ¹⁶  Moreover, the anti‐inflammatory activity of curcumin inhibits leukotriene formation, platelet aggregation, and stabilization of neutrophilic lysosomal membranes and thus, helps in controlling acne without side effects. ³⁷ Different studies have reported the effectiveness of neem‐based and turmeric‐based skincare products to heal acne. ⁹ , ¹⁰ , ²¹ , ³⁴ , ³⁸ , ³⁹

Singh et al. (2015) evaluated safety, stability, and consumer acceptance of an anti‐acne synergistic herbal face wash gel (containing neem, turmeric, and lemon) and detected its effectiveness and high consumer acceptance due to the light foaming effect, natural fragrance, and no skin irritation. ³⁴ Similarly, Debbarma et al. ⁹ reported a clinical study on a neem‐based herbal face wash on healthy volunteers with no skin irritation and remarkable reduction in the oiliness of the facial skin and minimization of acne. Likewise, Charde et al. ¹⁰ described a herbal formulation using neem to treat acne by destroying the growth of P. acnes and S. epidermidis without adverse effect. In line with these studies, a study by Sowmya et al. (2015) reported the effectiveness of a herbal product formulation with neem to treat acne. ²¹ Additionally, the use of neem and turmeric to treat acne (without any side effect) by reducing the production of harmful reactive oxygen species by P. acnes has been reported in the literature. ³⁷ , ³⁸ In agreement to the previous studies, ⁹ , ¹⁰ , ²¹ , ³⁴ , ³⁷ , ³⁹ no adverse effect of PNFW was reported by the subjects in the current study and the reduction and/prevention of acne was attained in four weeks.

Hydration is an essential factor to regulate skin barrier function and metabolism, which keeps skin healthy. ⁴⁰ In acne vulgaris, the skin barrier function has been found to be diminished along with the reduction of the epidermal ceramide level (lowering hydration). In addition, most of the systemic and topical medications recommended to treat acne, disrupt the skin barrier function leading to irritation and dry skin conditions. ⁴  Therefore, the skincare product (particularly face wash) for acne patients should have a moisturizing property to retain skin moisture, to prevent dehydration of the skin, and at the same time to keep the skin smooth. ²¹ For acne‐prone skin types, a variety of specialized cleansers and moisturizers are available as suitable adjunctive therapies. Lipid‐free, non‐irritating, non‐comedogenic, non‐allergenic, and non‐acnegenic products are considered to be the ideal type of cleansers for acne‐prone skin. ⁴ , ⁴¹ Lipid‐free cleansers (containing emollients and humectants, oil absorbers) reported low risk of causing skin irritation and dryness. Moreover, they can maintain near‐physiological stratum corneum pH, thereby prevent the growth of P. acnes. Draelos et al. (2016) conducted a study on 27 mild‐moderate acne patients to assess the efficacy and tolerability of a twice daily, three‐product skincare regimen using alpha‐hydroxy acids and retinoids in combination with salicylic acid in acne patients. A statistically significant reduction in inflammatory and non‐inflammatory lesions (p = 0.006 and p = 0.015, respectively) was observed after 4 weeks and 8 weeks and also there was further improvement (with highly significant decrease; p < 0.001) in both types of lesion counts. ¹⁵ Similarly, Leyden et al. (2008 and 2012) conducted two separate studies to determine the therapeutic effectiveness of benzoyl peroxide against P. acnes. Both studies reported an effective reduction in the quantity of P. acnes populations after the use of benzoyl peroxide ⁴² , ⁴³ and also, one of the studies stated the effectiveness of benzoyl peroxide in controlling antibiotic resistance. ⁴³  Moreover, a systematic review had investigated different modalities such as antiseptic cleansers, frequency of face wash usage, alpha and beta‐hydroxy (ie, salicylic) acid cleansers, true soap/cleansing bars to formulate treatment recommendations for acne vulgaris patients. As per the review, the use of cleansers and face washing can be beneficial single interventions. However, due to limited number of well‐conducted clinical studies on face wash and cleansers, the authors were not able to provide any consistent recommendation for acne patients. ²⁵ However, studies have reported skin irritation associated with the above‐mentioned agents as well. ¹⁵

Presently, herbal preparations are used to develop new skincare products with different therapeutic properties that lead to skin hydration and consequently maintain skin water balance. ⁴⁰ PNFW has been found to be safe and efficacious in lowering the sebum level of the facial skin without affecting the skin hydration level based on clinical, instrumental, and qualitative evaluations. The effectiveness of PNFW in prevention and reduction of mild‐to‐moderate acne without any side effect can be due to the presence of natural and herbal ingredients—neem and turmeric as well as its mild soap‐free formulations that aid in removing pollutants, dirt, and other secretions of the facial skins and at the same time restoring the hydration and moisture balance. This in turn can further prevent other common skin problems like skin oiliness, skin redness, pigmentation, and clogging of pores.

The main limitation of this study was its single‐arm observational design without any comparator. Therefore, the effect of the product could not be compared with any other skincare product. Another limitation was that the study duration was short, hence, long‐term safety and efficacy of PNFW could not be evaluated.

Overall, the present study indicated the beneficial effect of natural and herbal ingredients of Himalaya's PNFW in the prevention and reduction of mild‐to‐moderate acne with no side effects. PNFW reduced sebum level of both cheeks as observed in sebumeter reading, indicating the prevention of recurrence of lesions, while maintaining adequate hydration as per corneometer assessment. Due to the ease and comfort in its use without any irritation and skin dryness, PNFW resulted in better compliance among the study subjects.

CONFLICT OF INTEREST

Dr Yogesh H R declares that there is no conflict of interest. Dr Trusha Gajjar and Dr Nayan Patel were part of the clinical study. Dr Rajesh Kumawat is an employee of The Himalaya Drug Company. The authors declare that any association have not influenced the work reported in this paper.

AUTHOR CONTRIBUTIONS

Dr Nayan Patel and Dr Trusha Gajjar have contributed in conducting clinical study, preparation and review of manuscript. Dr H R Yogesh being subject expert contributed in the review of manuscript. Dr. Rajesh Kumawat contributed in the revisions and finalization of manuscript.

Yogesh HR, Gajjar T, Patel N, Kumawat R. Clinical study to assess efficacy and safety of Purifying Neem Face Wash in prevention and reduction of acne in healthy adults. J Cosmet Dermatol. 2022;21:2849–2858. 10.1111/jocd.14486

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.