Table 3.
Clinical studies evaluating the safety and efficacy of topical retinoids for acne in skin of color
| AGENT(S) | AUTHOR | SKIN-OF-COLOR PATIENTS (FST) | STUDY DESIGN | EFFICACY | SAFETY | PIH EFFICACY |
|---|---|---|---|---|---|---|
| Adapalene 0.1% vs. tretinoin 0.025% | Goh et al107 | N=73, 19 Chinese (III–IV), 20 Indian (V–VI), 20 Malay (IV–V), 14 Caucasian (I–III) |
Randomized, investigator-blinded, split-face and forearm tolerability study | NS | Irritation potential of adapalene 0.1% was significantly lower than tretinoin 0.025% in all tolerability assessments for face and forearm. Order or tolerance: Chinese (most susceptible to irritation) > Indians > Malays > Caucasians (least susceptible) |
NS |
| Adapalene 0.1% vs. tretinoin 0.025% | Tu et al108 | N=150, all Chinese (I–IV) | 8-week, randomized, double-blind, comparison study | Equivalent efficacy: >69% reduction in total, inflammatory and noninflammatory lesion counts. >70% in both groups had complete clearance or marked improvement. | Local irritation (erythema, scaling, burning, pruritus, dryness) were mild but more common with tretinoin (45.7%) than adapalene (32.4%). | NS |
| Adapalene 0.1% | Jacyk et al109 | N=65, 64 African, 1 Indian | 12-week, open-label study | Significant reductions in mean inflammatory, noninflammatory, and total lesion counts from baseline to endpoint (P<0.01). | <5% reported moderate-to-severe skin irritation. | Yes |
| Adapalene 0.1% vs. vehicle gel | Kawashima et al110 | N=193, all Japanese | 12-week, randomized, investigator-blinded, vehicle-controlled study | Median percent reduction of total lesion counts at endpoint was significantly greater with adapalene (63.2%) compared to vehicle (36.9%) (P<0.0001). Significant reductions in total (P<0.0001), inflammatory (P=0.01), and noninflammatory (P<0.001) lesions with adapalene over vehicle at endpoint. | 32.2% experienced AEs related to study drug, 56% in adapalene-treated group, 8.1% in vehicle-treated group. Most common AE: dryness. All dermatological AEs were transient and mild to moderate. |
NS |
| Tazarotene 0.05% | Grimes PE111 | N=14, 10 African American, 4 Hispanic, (all V–VI) | 8-week, pilot study | Significant reductions in mean inflammatory and noninflammatory lesion counts from baseline to endpoint. | No significant changes in mean pigmentary intensity in patients' skin and no irritation. Not likely to cause irritation-induced hyperpigmentation. | Yes* |
| Tazarotene 0.1% | Saple et al112 | N=126, all Asian Indian | 14-week, open-label study | Significant reductions in mean inflammatory, noninflammatory, and total lesion counts from baseline to endpoint. Complete to moderate clearing in 93.6%. | AEs in 11.9%; Pruritus most common (4.8%). | NS |
FST= Fitzpatrick skin type
AEs= Adverse events
NS= Not stated
*
Following study showed tazarotene to be effective for acne-induced PIH in darker skin. Grimes PE, Callender VD. Tazarotene cream for postinflammatory hyperpigmentation and acne vulgaris in darker skin: a double-blind, randomized, vehicle-controlled study. Cutis. 2006;77:45–50.