乌鸦传媒

A three-pronged acne treatment known as IDP-26 demonstrated greater efficacy than single and double treatments recently in matching randomized phase 3 trials.

IDP-126 gel is a fixed-dose therapy consisting of topical clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1%. The report was published in .

The 12-week studies randomized participants ages 9 or older with moderate or severe acne (n=183 and n=180, respectively) to receive either daily IDP-126 or a control treatment.

At week 12, 49.6% and 50.5% of moderate and severe participants receiving IDP-126, respectively, met the trial's treatment end points, compared with 24.9% and 20.5% with those receiving the control gel (P<.01, both). IDP-126 also reduced the prevalence of inflammatory and noninflammatory lesions when compared with control.

Linda Stein Gold, MD, director of dermatology clinical research and division head of dermatology at Henry Ford Health in Michigan served as the paper's first author. The following study excerpts have been edited for length and clarity.

What was the impetus for this study?

Combination therapies are recommended in the U.S. for most patients with acne, and there are several approved prescription topical dyad products that contain some combination of benzoyl peroxide, a retinoid, or an antibiotic.

A topical gel known as IDP-126, which contains clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%, is the first fixed-dose, triple-combination formulation for acne treatment. A combination containing clindamycin phosphate (a lincosamide antibiotic with anti-inflammatory effects), benzoyl peroxide (an antibacterial agent with keratolytic effects and mild comedolytic activity), and adapalene (a third-generation retinoid that modulates cellular differentiation, proliferation, and keratinization) targets three of the four acne pathogenic pathways.

The addition of benzoyl peroxide to clindamycin phosphate reduces antibiotic resistance that has been observed with topical antibiotic monotherapy.

The objective of the two identically designed phase 3 clinical studies was to confirm the efficacy, safety, and tolerability of IDP-126 gel versus vehicle gel treatment for moderate-to-severe acne.

What were the key findings on the efficacy of IDP-126?

IDP-126 demonstrated superior efficacy on all three co-primary endpoints versus vehicle gel and was well tolerated in both studies.

Reductions in inflammatory and noninflammatory lesion counts with IDP-126 were 72% to 80%, respectively, and half of participants (49.6% and 50.5%) achieved treatment success by week 12. IDP-126 also showed rapid significant percent reductions in lesion counts as early as week 4 in both studies.

The results from the current studies are consistent with those observed in a phase 2 study in which IDP-126 was superior to vehicle gel on all 3 co-primary efficacy endpoints at week 12, with more than 70% reductions in inflammatory and noninflammatory lesions and 52.5% of participants achieving treatment success.

What were the safety findings?

In both studies, more participants in the IDP-126 group reported treatment-emergent adverse events (TEAEs) than did those in the control group.

Most TEAEs were mild-to-moderate in severity. The most commonly reported were erythema, application site pain, dryness, irritation, and exfoliation.

What are the key take-home messages for dermatologists?

In general, these results confirm that the novel, once-daily, fixed-dose, triple-combination IDP-126, in an elegant delivery system, is an efficacious and well-tolerated acne treatment. With its simple treatment regimen containing three recommended acne treatments, IDP-126 is a potential new treatment option for acne.

No direct comparisons can currently be made, however, between IDP-126 and other treatments, as no comparative-effectiveness or similar studies have been conducted.

Key points:

• Triple-agent, fixed-dose acne treatment IDP-126 was shown to be safe and effective against moderate-to-severe acne in patients ages 9 and above.
• Adverse events were more prevalent than IDP-126 but were mainly mild to moderate.
• Adverse events included exfoliation, application site pain, dryness, and irritation.