Safety and Tolerability of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants With Acne

Abstract

Background: As acne can cause inflammation-associated sequelae (eg, post-inflammatory hyperpigmentation) in individuals with melanin-rich skin, effective and rapid management must be balanced with minimization of skin irritation. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (IDP-126) polymeric mesh gel is the first fixed-dose, triple-combination topical acne product in development. In clinical studies, over half of participants achieved treatment success with IDP-126 gel after 12 weeks. The objective of this pooled, post hoc analysis was to evaluate safety and tolerability of IDP-126 gel in Black participants.

Methods: In two identical phase 3, double-blind, randomized, 12-week studies (NCT04214639; NCT04214652), participants aged ≥9 years with moderate-to-severe acne were randomized (2:1) to receive once-daily IDP-126 or vehicle gel. Assessments included treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability (hyperpigmentation, hypopigmentation, erythema, scaling, itching, burning, and stinging; graded from 0 [none] to 3 [severe]). Post hoc analyses were based on participants’ self-identification of race as ‘Black or African American’ (hereafter referred to as Black).

Results: Of 363 randomized participants, 54 (14.9%) self-identified as Black. No serious TEAEs were reported and no TEAEs led to discontinuation. Treatment-related TEAEs were reported in 7 (17.5%) IDP-126-treated Black participants; the most common were application site pain (n=5 [12.5%]) and application site pruritus (n=2 [5.0%]). No vehicle-treated participants reported treatment-related TEAEs. TEAEs in Black participants were generally similar to the overall population.

Mean severity scores for all cutaneous safety/tolerability assessments following IDP-126 treatment were <0.55 at all study visits (1=mild). Rates of hyperpigmentation remained relatively unchanged throughout the study while erythema decreased by over 10% from baseline to week 12 with IDP-126 treatment. Rates of all other cutaneous safety/tolerability assessments were low (<9%) at both baseline and week 12.

Conclusions: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (IDP-126) gel was safe and well tolerated in Black participants with moderate-to-severe acne over 12 weeks, with no discontinuations or serious TEAEs. Additionally, IDP-126 treatment led to improved erythema in Black participants and no substantial increases in hyperpigmentation. These post hoc analyses add valuable information to the limited literature describing treatment effects and tolerability of novel acne therapeutics in Black individuals.

Support: Ortho Dermatologics.