Overview of New Therapeutic Developments for Acne

Anja Thielitz; Harald Gollnick


April 13, 2009

In This Article

Combination of Topical Retinoids and Antimicrobials

Owing to the multifactorial nature of acne pathogenesis, combination therapies have been developed targeting two or more causative elements of the disease and enhancing treatment efficacy,[34] which has been demonstrated for 'single-agent combination regimens' of tretinoin and erythromycin or BPO, adapalene and clindamycin or adapalene and BPO. A fixed combination provides the advantage of increasing patient compliance by facilitating application modus, increasing adherence and avoiding efficacy problems by substance incompatibilities due to application errors (e.g., oxidation by using tretinoin and BPO at the same time). Such fixed combinations with improved clinical efficacy include tretinoin/erythromycin, isotretinoin/erythromycin[21,34] and recently approved fixed combinations of tretinoin 0.025% and clindamycin phosphate 1.2% (Ziana®, Medicis, AZ, USA) and adapalene 0.1% and BPO 2.5% (Epiduo®, Galderma).

In three randomized, 12-week, double-blind studies involving more than 4500 patients, the combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (Ziana) was well tolerated and significantly more effective than clindamycin 1.2% gel, tretinoin 0.025% gel or vehicle gel in reducing inflammatory, noninflammatory and total lesion counts (p < 0.001).[35] This novel formulation combines clindamycin phosphate lotion 1.2% solution (equivalent to 1% clindamycin) with a crystalline suspension of tretinoin in an alcohol-free, aqueous-based gel and was approved by the FDA in 2006 for the treatment of acne vulgaris in patients older than 12 years of age.[36]

The fixed combination of adapalene 0.1% and BPO 2.5% gel (Epiduo) was approved in Argentina and Europe in 2008 for the cutaneous treatment of acne vulgaris (in subjects 12 years of age or older) on the face, chest and back when comedones, papules and pustules are present. In a multicenter, randomized, double-blind, 12-week, parallel-group study involving 517 subjects with moderate-to-moderately severe acne, the fixed combination of adapalene 0.1% and BPO 2.5% gel was significantly more effective (p < 0.001) and had a faster onset of action than monotherapies and vehicle.[37] The safety of the fixed adapalene/BPO combination was assessed in a 12-month long-term safety study including 452 subjects and showed constant good tolerability.[38] Adverse events were limited to mild dermal irritation occurring in the first few weeks of treatment and decreasing thereafter.


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