Fixed-dose IDP-126 demonstrates fast-acting relief, sustained clearance for acne

Key takeaways:

• 82.7% of patients treated with the triple combination gel achieved at least a 33% reduction in inflammatory lesions by week 4.
• 65.8% also achieved at least a 75% reduction in inflammatory lesions by week 12.

Fixed-dose clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1% gel achieved faster-acting efficacy than dyads and vehicle, according to a study.

“While several oral and topical drugs are currently available for acne therapy, treatment can be challenging owing to the chronic nature of acne and its multifactorial underlying pathology,” Julie C. Harper, MD, a dermatologist at the Dermatology & Skin Care Center of Birmingham, and colleagues wrote. “Treatment is further hindered by low adherence typical of acne therapies, with multiple factors contributing to nonadherence including side effects, difficulty incorporating the treatment routine and treatment cost.”

According to the authors, adherence can be further exacerbated by a lack of fast-acting treatments. As a result, combination therapies, which simultaneously target multiple processes of acne pathogenesis, are recommended in the U.S. for most patients with acne.

Approved as the first triple-combination gel for acne, IDP-126 (Cabtreo, Bausch Health), a combination of clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1%, is one such option. In this clinical analysis, Harper and colleagues evaluated whether more patients would achieve reductions in their acne with IDP-126treatment vs. dyads and vehicle.

The analysis pulled data from one phase 2 and two phase 3 double-blind, 12-week studies. Three dyads were included in the phase 2 study as part of the analysis — benzoyl peroxide/adapalene, clindamycin phosphate/benzoyl peroxide and clindamycin phosphate/adapalene — as well as the vehicle gel.

In the double-blind studies, a total of 1,104 patients aged 9 years and older (mean age range, 19.8-21.4 years) with moderate to severe acne were randomly assigned to once-daily IDP-126, a dyad or vehicle. Researchers evaluated each patient’s progress at weeks 2, 4, 8 and 12.

Results showed that IDP-126 demonstrated rapid onset of action with a significantly higher proportion of patients treated with CAB gel achieving at least a 33% reduction in inflammatory lesions (82.7%) vs. all three dyads (range, 65.9%-69.8%) and vehicle (64.1%) as early as week 4.

Not only did IDP-126 demonstrate fast-acting relief, but also sustained clearance, Harper and colleagues wrote. By week 12 in the phase 2 study, 65.8% of patients treated with IDP-126 had at least a 75% reduction in inflammatory lesions — a significantly greater proportion than all three dyad groups (range, 49.9%-51.2%) and vehicle (21.6%).

The phase 3 pooled data showed similar results, with 68.1% of the IDP-126 group achieving at least a 75% reduction in inflammatory lesions vs. 33.4% in the vehicle group by week 12 (P .001).

“This fast-acting feature of [IDP-126] — coupled with its optimized efficacy, once-a-day application and good tolerability — may positively impact treatment adherence, positioning [IDP-126] gel as a desirable treatment option for patients with moderate to severe acne,” the authors concluded.