Adapalene-Benzoyl Peroxide Combination Product for Acne
Adapalene-Benzoyl Peroxide Combination Product for Acne
Adapalene-Benzoyl Peroxide, a Fixed-Dose Combination for the Treatment of Acne Vulgaris: Results of a Multicenter, Randomized Double-Blind, Controlled Study
Adapalene and benzoyl peroxide (BPO) are common topical agents used to treat mild-to-moderate acne vulgaris (AV) and are often administered in combination. Adapalene is a topical retinoid that treats AV through multiple mechanisms, including comedolysis and anti-inflammatory effects. Topical BPO products (washes, creams, gels) work primarily through bactericidal action against Propionibacterium acnes -- a crucial trigger of inflammation in AV.
Thiboutot and colleagues investigated the safety and efficacy of a combination product that contains both adapalene 0.1% gel and BPO 2.5% (adapalene-BPO). This large multicenter study included 517 subjects with mild-to-moderate acne who were randomized to receive either adapalene-BPO, adapalene 0.1% gel, BPO 2.5% gel, or vehicle applied once daily (2:2:2:1 randomization, respectively). The inclusion criteria for the study were as follows: age >12 years, 30-100 noninflammatory acne lesions, 20-50 inflammatory acne lesions, and no nodules or cysts. Investigators assessed treatment efficacy at 1, 2, 4, 8, and 12 weeks using an investigator's global assessment scale (IGA) of acne severity and the percentage of lesion reduction from baseline (total, inflammatory, and noninflammatory). Treatment tolerability and safety were assessed at multiple timepoints using measurements including investigator-rated erythema, scaling, dryness, and burning.
Patients applying adapalene-BPO exhibited superior results to other treatment arms, showing a greater reduction in IGA scores, total acne lesion counts (evident after week 1), and inflammatory and noninflammatory lesion counts. After 12 weeks of treatment, the success rate (percentage of patients judged to be "clear" or "almost clear") in the adapalene-BPO group approached 30%, which was almost twice the success rate seen in the adapalene-only and BPO-only groups. Of note, adverse effects and tolerability were comparable in the adapalene-BPO vs adapalene 0.1% gel groups.
AV is an inflammatory disorder of the pilosebaceous unit, precipitated and exacerbated by a multitude of factors, including hyperkeratinization of the follicular orifice (comedo formation), excessive sebum production (under genetic and hormonal influence), and proliferation of the proinflammatory bacterium Pacnes. Because these different components of AV are responsive to different agents, combination therapy is the cornerstone of effective management. Hence, topical retinoids are used to induce comedolysis, while topical and oral antibiotics and/or topical BPO products inhibit P acnes growth.
Currently marketed combination products include BPO-clindamycin and clindamycin-tretinoin formulations. These products improve patient compliance by creating a streamlined topical regimen while enhancing clinical efficacy. The data presented by Thiboutot and colleagues suggest that combination adapalene-BPO may be a useful new topical agent against mild-to-moderate AV, but additional questions need to be addressed in future studies, including the following:
Furthermore, the introduction of another topical product will not change the fact that patients with more significant AV (moderate to severe, nodulocystic) still need the addition of oral therapy (antibiotics or isotretinoin) to achieve successful disease control.
Abstract
Adapalene-Benzoyl Peroxide, a Fixed-Dose Combination for the Treatment of Acne Vulgaris: Results of a Multicenter, Randomized Double-Blind, Controlled Study
Thiboutot DM, Weiss J, Bucko A, et al
J Am Acad Dermatol. 2007;57:791-799
Adapalene and benzoyl peroxide (BPO) are common topical agents used to treat mild-to-moderate acne vulgaris (AV) and are often administered in combination. Adapalene is a topical retinoid that treats AV through multiple mechanisms, including comedolysis and anti-inflammatory effects. Topical BPO products (washes, creams, gels) work primarily through bactericidal action against Propionibacterium acnes -- a crucial trigger of inflammation in AV.
Thiboutot and colleagues investigated the safety and efficacy of a combination product that contains both adapalene 0.1% gel and BPO 2.5% (adapalene-BPO). This large multicenter study included 517 subjects with mild-to-moderate acne who were randomized to receive either adapalene-BPO, adapalene 0.1% gel, BPO 2.5% gel, or vehicle applied once daily (2:2:2:1 randomization, respectively). The inclusion criteria for the study were as follows: age >12 years, 30-100 noninflammatory acne lesions, 20-50 inflammatory acne lesions, and no nodules or cysts. Investigators assessed treatment efficacy at 1, 2, 4, 8, and 12 weeks using an investigator's global assessment scale (IGA) of acne severity and the percentage of lesion reduction from baseline (total, inflammatory, and noninflammatory). Treatment tolerability and safety were assessed at multiple timepoints using measurements including investigator-rated erythema, scaling, dryness, and burning.
Patients applying adapalene-BPO exhibited superior results to other treatment arms, showing a greater reduction in IGA scores, total acne lesion counts (evident after week 1), and inflammatory and noninflammatory lesion counts. After 12 weeks of treatment, the success rate (percentage of patients judged to be "clear" or "almost clear") in the adapalene-BPO group approached 30%, which was almost twice the success rate seen in the adapalene-only and BPO-only groups. Of note, adverse effects and tolerability were comparable in the adapalene-BPO vs adapalene 0.1% gel groups.
Viewpoint
AV is an inflammatory disorder of the pilosebaceous unit, precipitated and exacerbated by a multitude of factors, including hyperkeratinization of the follicular orifice (comedo formation), excessive sebum production (under genetic and hormonal influence), and proliferation of the proinflammatory bacterium Pacnes. Because these different components of AV are responsive to different agents, combination therapy is the cornerstone of effective management. Hence, topical retinoids are used to induce comedolysis, while topical and oral antibiotics and/or topical BPO products inhibit P acnes growth.
Currently marketed combination products include BPO-clindamycin and clindamycin-tretinoin formulations. These products improve patient compliance by creating a streamlined topical regimen while enhancing clinical efficacy. The data presented by Thiboutot and colleagues suggest that combination adapalene-BPO may be a useful new topical agent against mild-to-moderate AV, but additional questions need to be addressed in future studies, including the following:
How does topical adapalene-BPO compare with tazarotene?
How does topical adapalene-BPO compare with other combination products (BPO-clindamycin, clindamycin-tretinoin)?
Furthermore, the introduction of another topical product will not change the fact that patients with more significant AV (moderate to severe, nodulocystic) still need the addition of oral therapy (antibiotics or isotretinoin) to achieve successful disease control.
Abstract