Table 3.
Review of Acne in Skin of Color.
| Authors | Study Design | Total # of Subjects (N) | Summary of Results | Level of Evidence | Strength of Recommendation |
|---|---|---|---|---|---|
| Tirado-Sanchez et al. (2013) | Single-center, randomized, double-blinded placebo-controlled study | 171 subjects (F=94; M = 77) | At 90 days of treatment, the efficacy rates of tretinoin 0.05% gel, adapalene 0.3% gel and adapalene 0.1% gel were 80%, 70%, and 59% respectively. Tolerance was better with adapalene 0.1% gel than with adapalene 0.3% and tretinoin 0.05% gel (P = 0.001). |
I | A |
| Grimes and Callender (2006) | Multicenter, randomized, double-blinded, vehicle-controlled study | 74 subjects (F=65; M=9) | Once-daily tazarotene 0.1% cream was significantly more effective than vehicle in lessening PIH overall (P = 0.010), and in reducing the intensity (P = 0.044) and area of hyperpigmented lesions (P = 0.026) within 18 weeks. | I | A |
| Alexis et al. (2014) | Multicenter, randomized, double-blinded, placebo-controlled study | 238 subjects (F=166; M=72) | After 12 weeks, significant reductions in total, inflammatory and noninflammatory lesion counts were observed with adapalene 0.1%/BPO 2.5% gel than vehicle. After 12 weeks, most subjects reported no dryness (> 89.9%), no erythema (> 90.9%), no scaling (> 96.0%), or no stinging/burning (> 94.9) with adapalene-BPO treatment. |
I | A |
| Callender (2012) | Multicenter, randomized, double-blinded, vehicle-controlled study | 797 subjects (F=408; M=389) | Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel was comparable between FST I-III and FST IV-VI at week 12. Patients with FST IV-VI were not found to be more susceptible to cutaneous irritation than patients with FST I-III. |
I | A |
| Callender et al. (2012a) | Multicenter, randomized, double-blinded, placebo-controlled study | 33 subjects (F=26; M=7) | Clindamycin phosphate 1.2%/tretinoin 0.025% gel-treated patients had a greater decrease in inflammatory lesion counts from baseline than vehicle group at week 12 (P = 0.05). | I | B |
| Kircik (2011) | Single-center, open-label pilot study | 20 subjects (F=15; M=5) | At week 16, azelaic acid 15% gel applied twice daily resulted in 92% of subjects with at least a one-point improvement in IGA for acne and 100% of subjects had at least a 2-point improvement in IGA for PIH. | II-iii | B |
| Piette et al. (2008) | Multicenter, randomized, double-blinded, vehicle-controlled crossover study | 64 subjects (F=35; M=29) | Subjects with glucose-6-phosphate dehydrogenase deficiency (G6PD) treated with dapsone 5% gel had only a 0.32 g/dL decrease in hemoglobin levels from baseline to 2 weeks; however, no changes were noted in reticulocytes, haptoglobin, bilirubin or lactate dehydrogenase levels. | I | A |
| Fleischer et al. (2006) | Multicenter, randomized, double-blinded, placebo-controlled study | 1038 subjects (F=449; M=589) | An extended release formulation of minocycline hydrochloride was evaluated in subjects with moderate to severe acne in a phase 2 dose finding study and two phase 3 safety and efficacy trials. Study participants received minocycline 1 mg/kg daily or placebo over 12 weeks. The number of inflammatory lesions was reduced and significant improvement was noted in the Evaluator’s Global Severity Assessment scores. In both the placebo and treatment groups, acute vestibular adverse events (AVAEs) were comparable. The authors concluded that extended release minocycline reduces dose dependent AVAEs, inflammatory lesions, and improves overall appearance of acne patients. |
I | A |
| Ullah et al. (2014) | Single-center, randomized controlled study | 386 subjects (F=215; M=171) | Subjects with moderate acne received either azithromycin 500 mg daily before meals for 4 consecutive days monthly for 3 months or doxycycline 100 mg daily after meals for 3 months and followed up after 3 months. An excellent response was noted in 3.1% and a good response was observed in 22.8% in the azithromycin group. In the doxycycline group, 11.4% had excellent and 55.4% had a good response. The authors concluded that doxycycline is the better treatment option for acne. | I | A |
| Tan et al. (2014) | Multicenter, randomized, controlled, noninferiority, investigator-blinded study | 266 subjects (F=39; M=227) | The efficacy and safety of oral isotretinoin versus doxycycline 200 mg plus adapalene 0.1%/benzoyl peroxide 2.5% gel (D+A/BPO) was compared in subjects with severe nodular acne over 20 weeks. The authors found that D+A/BPO showed a favorable composite efficacy/safety profile compared with isotretinoin and concluded that this combination can be used as an alternative to isotretinoin in severe nodular acne. | I | A |
| Kelly and Sampson (1987) | Case series | 10 subjects | 10 African American subjects with recalcitrant nodulocystic acne treated with isotretinoin developed an early onset flare of nodulocystic lesions at sites initially devoid of acne lesions at weeks 2-4. At completion of the study, an improvement in PIH was noted. Between weeks 2-8, most subjects developed a reversible ashen or grayish facial hue (due to the drying and desquamative effects of isotretinoin). |
II-iii | B |
| Khunger et al. (2011) | Case series | 30 subjects (F=20; M=10) | Subjects with FST IV and V with atrophic ice pick acne scars were primed for 2 weeks (with hydroquinone 4% cream in the morning and tretinoin 0.025% cream at night) prior to receiving focal application of 100% trichloroacetic acid (TCA) to each scar at 2-week intervals for 4 sessions. Excellent improvement was seen in 73.3% of subjects, while 20% showed good improvement and 6.7% had fair results. Transient hypopigmentation was observed in 1 patient and hyperpigmentation was observed in 2 patients. No significant prolonged pigmentary changes or scarring were noted at 3 month follow-up. |
II-iii | C |
| Gold (2012) | Case series | 5 subjects (F=3; M=2) | Subjects with FST IV and V treated with a novel superficial and deep AcuPulse MultiMode carbon dioxide (CO2) fractional laser had clinically significant improvement in acne and no reports of PIH were noted. | II-iii | C |
| Semchyshyn et al. (2013) | Case series | 20 subjects | Subjects with FST IV through VI treated with a nonablative 450-nm diode laser found it to be effective in improving the appearance of atrophic acne scars, however, PIH was common in 56% of subjects. | II-iii | C |
| Karnik et al. (2014) | Multicenter, randomized, double-blinded, controlled study | 147 subjects (F = 90; M = 57) | Subjects with at least 4 moderate to severe rolling, atrophic scars randomly received polymethylmethacrylate (PMMA) suspended in bovine collagen (PMMA-collagen) or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups. | I | B |
* In accordance with the US Preventive Services Task Force levels of evidence for grading clinical trials (Sheth and Pandya, 2011b), (see Appendix A).
Abbreviations: F, female; M, male; BPO, benzoyl peroxide; PIH, postinflammatory hyperpigmentation; FST, Fitzpatrick skin type; IGA, investigator global assessment.