Newly approved IDP-126 gel for acne significantly improves patient quality of life

Key takeaways:

• IDP-126 vs. vehicle improved patient emotions, self-perceptions, acne symptoms and socialization.
• Disease severity had a higher likelihood of influencing quality of life improvements (53.8%-63.3%).

Newly FDA-approved IDP-126 gel improved quality of life outcomes in patients with acne vulgaris over vehicle, according to a study.

IDP-126 gel (Cabtreo, Bausch Health), a combination topical of clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1%, was recently approved for the treatment of acne vulgaris in patients aged 12 years and older, making it the first FDA-approved, fixed-dose triple-combination gel for this population.

In a post hoc exploratory analysis comprised of pooled data from two phase 3 studies with 306 patients aged 13 years and older, Linda Stein Gold, MD, director of clinical research in the department of dermatology at Henry Ford Health and the study’s lead author, and colleagues used the acne-specific quality of life (QoL) questionnaire to assess the QoL effects of this newly approved triple-combination gel.

Each patient was randomly assigned to receive IDP-126 gel or vehicle for 12 weeks prior to completing the questionnaire. Responses indicated that QoL was significantly improved with IDP-126 compared with vehicle.

According to the Acne-QoL questionnaire, IDP-126 gel vs. vehicle improved patients’ scores in emotional well-being (least squares mean difference [LSMean] from baseline, 4.1), self-perception (LSMean, 3.8), acne symptoms (LSMean, 2.6) and social well-being (LSMean, 2) at week 12 (P < .001 for all).

The researchers also found significantly greater proportions of responders among those treated with IDP-126 gel vs. vehicle, suggesting that patients considered IDP-126 gel clinically meaningful, including in self-perception (OR = 4.32; 95% CI, 2.16-8.65), acne symptoms (OR = 3.9; 95% CI, 2.11-7.23), social well-being (OR = 3.59; 95% CI, 1.73-7.47) and emotional well-being (OR = 2.5; 95% CI, 1.36-4.58).

Evaluator’s Global Severity Score (EGSS) had a higher likelihood of influencing QoL improvements across all QoL categories (53.8%-63.3%) compared with reduction in inflammatory (20.1%-33.4%) or non-inflammatory lesion counts (9.5%-18.7%).

“This post hoc exploratory analysis of pooled phase 3 data [moderate to severe acne] suggests that treatment with IDP-126 gel led to statistically significant and clinically meaningful improvements in QoL and improvement in QoL was primarily influenced by EGSS,” Stein Gold and colleagues wrote.

Reference:

• FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older. https://ir.bauschhealth.com/news-releases/2023/10-20-2023. Posted Oct. 20, 2023. Accessed Oct. 30, 2023.