Abstract
Seborrheic dermatitis (SD) is a chronic inflammatory skin condition that commonly involves the scalp, and thus, affects a diverse demographic with varying hair care needs. Current SD treatments are limited based on optimized formulation, efficacy, adverse events, and lack of placebo-controlled trials. A novel roflumilast foam formulation has emerged as a promising therapeutic option optimally designed for use on the scalp and other hair-bearing areas. We conducted a comprehensive assessment of beauty industry standards, confirming the foam formulation's alignment with industry guidelines and exclusion of potentially harmful ingredients. In addition, consultation with an expert dermatologist panel yielded a strong endorsement, underscoring a high level of confidence in prescribing the foam across diverse hair and skin types.
Keywords: Seborrheic dermatitis
Seborrheic dermatitis (SD) is a chronic inflammatory skin condition marked by erythematous, scaly plaques with a distinctive yellow or white "greasy" scale appearance. While this condition can affect individuals across all demographics, certain hair care practices can exacerbate its severity. For example, regimens that include the use of chemical relaxers and hair extensions may inadvertently worsen symptoms.1 These considerations are particularly relevant when addressing the condition in diverse populations across a spectrum of hair types, highlighting the need for versatile and gentle treatment options.
The current therapeutic landscape for SD is diversified but not without drawbacks. Topical antifungals, while a cornerstone of SD management, commonly cause skin irritation, burning, and/or dryness.2,3 Moreover, the efficacy of antifungal shampoos may be influenced by hair washing frequencies, which are often dictated by hair type and texture and can range from daily to intervals of several weeks.4 Topical corticosteroids, another mainstay, come with the risk of adverse effects such as atrophy, telangiectasias, dyschromia, and systemic absorption with long-term use. Topical calcineurin inhibitors minimize some of these adverse events, but their chronic use has been tempered by overall limited efficacy and side effects of burning, stinging, and a controversial risk profile that includes lymphoma.5 The off-label use of the first-generation topical phosphodiesterase-4 (PDE4) inhibitor crisaborole (currently approved only for atopic dermatitis), while reportedly effective for some, causes application site pain for 14 to 32 percent of users.6 Similarly, the infrequent off-label use of oral apremilast, a PDE4 inhibitor currently approved only for psoriasis, has been linked to gastrointestinal symptoms, headache, and other side effects.7 These concerns highlight a pressing need for novel therapies that can effectively manage SD while minimizing side effects.
The introduction of roflumilast foam, recently approved by the FDA in December 2023 for treatment of seborrheic dermatitis in individuals aged 9 years or older, represents a significant advancement in the management of this chronic, burdensome inflammatory disease. Roflumilast, a selective inhibitor of PDE4, exhibits a binding affinity exceeding that of crisaborole and apremilast by a factor of between 25- to over 300-fold.8 Roflumilast foam demonstrates remarkable efficacy in alleviating key signs and symptoms of seborrheic dermatitis, with nearly 80 percent of patients achieving complete or nearly complete clearance by Week 8. Additionally, it maintains a favorable safety and tolerability profile, as evidenced by its low rates of application site reactions.6
The formulation of roflumilast foam aims to maintain hair integrity while effectively delivering the therapeutic agent to the skin, especially hair-bearing areas such as the scalp. Yet, any formulation has the potential to interfere with the natural properties of hair, particularly across individuals with diverse skin types. To ensure the formulation meets the needs of all hair types for managing SD, we undertook a comprehensive review of beauty industry standards and consulted with an expert dermatologist panel composed of leading medical and cosmetic dermatologists with expertise in formulation. The formulation has received a robust endorsement from this board and aligns with established industry standards, affirming its status as a safe and effective treatment option for all hair types in the management of seborrheic dermatitis.
PRODUCT FORMULATION AND TESTING
Roflumilast foam, designed as a water-based formulation, excludes fragrances and known irritants and sensitizers. Its formulation is balanced to further minimize skin irritation by matching the natural pH of the stratum corneum, employing a low water concentration per dose, and utilizing scalp-targeted application methods with balanced emollients. Moreover, the foam's composition includes ingredients that ensure its suitability for a wide variety of skin and hair types.
A key component of the formulation is Crodafos CES emulsifying wax, serving as the primary non-active ingredient responsible for the foam's structure. Crodafos CES is a mild emulsifier and conditioning agent used in the cosmetic industry. Crodafos CES has an unusually high Krafft temperature, which was found to play a crucial role in inhibiting micelle formation at normal skin temperatures including bathing. This property prevents the deposition of negative charges on hair fibers, a common problem with typical surfactants that can increase hair's electrostatic charge and exacerbate frizz. The inhibition of micelle formation by Crodafos CES leads to its repulsion from innately negatively charged hair strands, enabling the foam to target the scalp effectively without adhering to the hair.9 Additionally, its inclusion in the formulation aids in reducing lag time, allowing the medication to penetrate the skin more quickly after application.10
Crodafos CES is utilized in the hair care industry due to its ability to enhance color retention and minimize cuticle damage during chemical treatments.11 Its integration across a diverse range of products, from dyes and shampoos to relaxers, underscores its versatility and effectiveness across various hair types and textures. Currently, Crodafos CES is an ingredient in at least 56 hair color and bleaching products, four hair treatment/serum products, and six styling gel/lotion products, many of which are designed specifically to cater to the needs of diverse curl patterns (Table 1).
TABLE 1.
List of common consumer products containing Crodafos CES
| PRODUCT TYPE | PRODUCTS | NUMBER OF PRODUCTS |
|---|---|---|
| Conditioner | Old Spice Beard Conditioner, Classic Scent; Zotos Professional, Nutri-Ox, Fortifying Conditioner | 2 |
| Hair Color and Bleaching | Clairol Nice ‘N Easy Permanent Hair Color (4 various shades); Clairol Natural Instincts Hair Color (12 various shades); Clairol Professional Shimmer Lights Permanent Cream Toner; Just For Men AutoStop Foolproof Hair Color (8 various shades); Just For Men Easy Comb-in Haircolor Kit (4 various shades); Just for Men Touch of Gray Mustache & Beard Multiple Application Facial Haircolor Kit; Zotos Professional Age Beautiful Hair Colors (26 various shades) | 56 |
| Hair Styling Gel/Lotion | Aussie Miracle Curls Frizz Taming Cream; Beyond The Zone Rock On Matte Clay; Schwarzkopf Got 2b Styling Spiking Glue; Mizani True Textures Curl Enhance Lotion; Pantene Pro-V Gold Series Hydrating Butter-Crème; Redken, Curvaceous for Spirals, Ringlet Shape Perfecting Lotion | 6 |
| Hair Treatment/Serum | As I am Whip, Cocoshea; Ion Masque For Damaged Hair; Mizani Strength-Fusion Intense Night-Time Treatment; Pattern Hydrating Mist | 4 |
| Shampoo | Sebastian Professional, Lightweight Shampoo, Dark Oil | 1 |
INDUSTRY STANDARDS AND EXPERT OPINION
The beauty industry is closely attuned to ingredients beneficial or harmful to hair health. Leveraging their expertise in identifying hair-friendly ingredients, we wanted to ensure that the formulation of roflumilast foam aligned with this sector's established standards. By evaluating the foam formulation against these standards, we aimed to assess its compatibility and safety for various hair types.
Building on this understanding, our assessment focused on ingredient categories cautioned against by the beauty industry due to their potential to adversely affect hair and skin health (Table 2). Sulfates, such as sodium lauryl sulfate (SLS) and sodium laureth sulfate (SLES), are often highlighted for their potential to cause hair dryness, due at least in part to their low Krafft temperature.12,13 The roflumilast foam formulation utilizes Transcutol, a highly purified form of diethylene glycol monoethyl ether (DEGEE), offering a gentler alternative without the risk of dryness and irritation.14 Similarly, dyes and preservatives are frequently discouraged by the industry due to their propensity for causing skin irritation and allergic reactions.15–20 The industry advises caution with certain thickening agents and alcohols, which can affect hair moisture and color,19 and fragrances, known for their risk of color stripping and skin irritation.21 Essential oils warrant caution due to their potential to trigger allergic contact dermatitis and alter hair color.22,23 Oxidizing agents such as hydrogen peroxide, bromates, and persulfates are known to break down natural hair color and can distort the color of dyed hair.24 Retinyl palmitate is associated with photosensitization and irritation, including peeling, scaling, itching, burning, and redness.25 Our comprehensive evaluation confirmed that the roflumilast foam formulation excludes ingredients recognized by the beauty industry as harmful to hair health.
TABLE 2.
Ingredients identified by the beauty industry as harmful and their associated adverse effects
| INGREDIENT CLASS | EXAMPLES | FUNCTION | ADVERSE EFFECT(S) |
|---|---|---|---|
| Sulfates |
|
Increase foaming | Increased hair dryness and frizziness due to stripping of natural oils and moisture.12 |
| Dyes |
|
Improve or balance color | Skin irritation, sensitization, and allergy.15–18 |
| Preservatives |
|
Prevent contamination and improve stability | Skin hypersensitivity and allergic contact dermatitis.19,20 |
| Thickening agents |
|
Thicken product | Both sodium chloride and PEGs can strip moisture and color from hair, and PEGs are linked to skin irritation and hypersensitivity reactions.19 |
| Fragrances |
|
Improve smell | Fragrance ingredients can strip color from hair and are some of the most common sources of allergic contact dermatitis.21 |
| Citrus and essential oils |
|
Improve aesthetics and smell | Essential oils and their compounds can cause allergic contact dermatitis.22 Lemon and some other citrus oils impart a yellow tinge to hair, whereas rosemary, rosewood, and cedarwood oils can darken hair color.23 |
| Alcohols |
|
Quicken drying time | Strip hair of moisture and artificial color at high concentrations.12 |
| Oxidizing agents |
|
Opens hair cuticle for product penetration | Can break down natural hair color and distort color of dyed hair.24 |
| Retinoids | Retinyl palmitate | Improve feel, body, sheen, texture | Associated with photosensitization and peeling, scaling, itching, burning, and redness of the skin.25 |
The formulation was further reviewed by a diverse expert panel comprising nine dermatologists and scholars from medical centers, dermatology clinics, and academic institutions across the United States. Their collective expertise in clinical practice, research, and dermatological innovation provided a comprehensive perspective on the formulation’s compatibility with hair and skin health. Through a detailed feedback and voting process, the experts aligned with the beauty industry’s standards on ingredient safety. Board experts independently supported many of the beauty industry’s guidelines on ingredients to avoid in foam products given potential skin impact – particularly in regard to dyes, preservatives, and irritants.
Upon review of formulation data and corresponding beauty industry standards, eight out of nine experts expressed feeling “extremely confident” about prescribing roflumilast foam to patients of diverse skin and hair types, including patients with previous hair treatments. This strong endorsement was anchored in the formulation’s adherence to beauty industry guidelines, specifically its exclusion of harmful ingredients, alongside the well-established use of ingredients like Crodafos CES in hair and skin care products.
CONCLUSION
The alignment of roflumilast foam's formulation with beauty industry standards and its validation by an expert dermatologist panel underscore its suitability for a diverse range of hair and skin types in the management of seborrheic dermatitis. The panel’s thorough review, which echoed the beauty industry's emphasis on potentially harmful ingredients, reinforces the foam formulation's safety profile. Ultimately, this novel foam emerges as a promising therapeutic option, offering effective and safe management of SD by leveraging familiar ingredients to enable the reliable delivery of a well-studied medication.
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