Fixed-Dose Acne Treatment Gel is Safe and Effective for Hispanic Patients, According to Post-Hoc Analysis

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A recent post-hoc analysis examined the efficacy and tolerability of a novel acne therapy in Hispanic patients, specifically.¹ The IDP-126 treatment gel is comprised of clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% (CAB). It is currently the only fixed-dose, triple-combination therapy that is approved by the US Food and Drug Administration (FDA) for acne.

Data was taken from a phase 2 trial (NCT03170388) and 2 phase 3 studies (NCT04214652 and NCT04214639), in which the gel demonstrated superior efficacy, safety, and tolerability. Patients (n =147) from these double-blind, vehicle-controlled, randomized studies who self-identified as Hispanic or Latino were included in this analysis. Over half were female.

Participants aged ≥9 years were randomized to apply either CAB (n = 90) or the vehicle cream (n = 57) once a day for 12 weeks. They were also provided with a hydrating cleanser, moisturizing lotion, and sunscreen to protect their skin and create an optimal skincare routine that supports CAB.

All had moderate to severe acne, which was established based on a score of 3 or 4 on the Evaluator’s Global Severity Score (EGSS). Furthermore, each participant had ≥30 to ≤100 inflammatory lesions, ≥35 to ≤150 noninflammatory lesions, and ≤2 nodules.

Investigators were aiming for treatment success (clear or almost clear skin), which was defined as a ≥2-grade reduction from baseline, according to EGSS, and a change in the number of lesions. Adverse events, cutaneous safety, and tolerability ratings were also assessed at weeks 2, 4, 8, and 12. The Acne-Specific Quality of Life (Acne-QoL) questionnaire was given at baseline and at the conclusion of the study to evaluate domains like self-perception, role-emotional, role-social, and acne symptoms.

By week 12, over 56% of the patients using CAB achieved treatment success, compared to 18.4% in the vehicle group (p < 0.001). More Hispanic patients achieved a ≥2-grade reduction in EGSS at weeks 4, 8, and 2 versus vehicle (p < 0.05).

Those who were treated with the CAB gel had >75% reductions in inflammatory and noninflammatory lesions by week 12. These changes were seen as early as week 2. An approximate 50% decrease was observed in those using the vehicle.

At week 12, improvements in Acne-QoL scores were greater in patients treated with CAB versus those treated with vehicle, especially in the domains of self-perception, role-social, and role-emotional. Baseline hyperpigmentation scores also decreased from 0.6 to 0.3 12 weeks after CAB treatment.

“These improvements with CAB are notable, as some racial and ethnic groups may experience greater deficits in daily functioning and quality of life owing to acne symptoms,” the authors noted.

Most reported adverse events with CAB were mild to moderate, with the most common ones being pain and pruritus at the application site. Tolerability was also mild with some transient increases in scaling, itching, burning, and stinging at week 2, but this returned to normal by week 8. No serious adverse effects occurred. These results in efficacy and safety were similar to the overall patient population in all previous trials, as well as a separate post-hoc analysis involving participants who self-identified as Black.²

Patients with skin of color are more likely to experience postinflammatory hyperpigmentation and irritation due to acne and any resulting treatments.³ Because of this, finding a safe and effective acne treatment for ethnically diverse populations is vital. Additional research can confirm the long-term efficacy of this combination gel therapy.

References

1. Callender VD, Baldwin H, Gold LS, Cook-Bolden FE, Guenin E, Alexis AF. Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in Hispanic participants with moderate-to-severe acne: a pooled analysis. J Dermatolog Treat. 2025;36(1):2480232. doi:10.1080/09546634.2025.2480232

2. Callender, V. D., Alexis, A. F., Bhatia, N., Harper, J. C., Guenin, E., & Baldwin, H. (2024). Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate-to-Severe Acne. SKIN The Journal of Cutaneous Medicine, 8(6), s495-s495.

3. Kundu RV, Patterson S. Dermatologic conditions in skin of color: part II. Disorders occurring predominately in skin of color. Am Fam Physician. 2013;87(12):859-865.