Product: Epiduo Gel
Pharmacologic class: Retinoid + antibacterial/keratolytic.
Active ingredient: Adapalene 0.1%, benzoyl peroxide 2.5%; gel.
Indication: For the treatment of acne vulgaris in patients >12 years of age.
Pharmacology: Epiduo Gel is a topical acne treatment that combines adapalene with benzoyl peroxide. Adapalene is a naphthoic acid derivative with retinoidlike properties that binds to specific retinoic acid nuclear receptors resulting in modulation of cellular differentiation, keratinization, and inflammation. Benzoyl peroxide is a highly lipophilic oxidizing agent that localizes in bacterial and keratinocyte cell membranes to exert bactericidal and keratolytic effects.
Clinical trials: Epiduo Gel was evaluated in two 12-week, multicenter, controlled clinical studies of similar design. At baseline, patients in both studies had between 20-50 inflammatory lesions and 30-100 noninflammatory lesions. Treatment response was defined as the percent of patients who had a two-grade improvement and rated “Clear” and “Almost Clear” at Week 12 based on the Investigator’s Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and noninflammatory lesion counts. In both studies, patients were randomized to one of four treatment groups: Epiduo Gel, adapalene 0.1% monotherapy, benzoyl peroxide 2.5% monotherapy, or vehicle gel.
Study 1: By Week 12, the mean percentage reductions in inflammatory lesions with Epiduo Gel were 52.4% compared with 31.8% of those using vehicle alone. The mean percentage reductions in noninflammatory lesions with Epiduo Gel were 45.9% compared with 27.8% for vehicle only. Also, the percentage of patients who had a two-grade improvement and rated “Clear” or “Almost Clear” on the IGA was 21.5% for Epiduo Gel compared with 5.6% for vehicle alone.
Study 2: By Week 12, the mean percentage reductions in inflammatory lesions with Epiduo Gel were 53.4% compared with 30.2% for vehicle alone. The mean percentage reductions in noninflammatory lesions with Epiduo Gel were 48.1% compared with 23.2% for vehicle only. The percentage of patients who had a two-grade improvement and rated “Clear” or “Almost Clear” on the IGA was 30.1% for Epiduo Gel compared with 11.3% for vehicle alone.
In both Studies 1 and 2, the treatment effect was smaller in subjects with a small number of baseline lesions than in subjects with a large number of baseline lesions.
Adults: Apply thin film to affected areas of face and/or trunk once daily after washing. Reduce frequency or discontinue if prolonged or severe irritation occurs.
Children: Not recommended.
Precautions: Do not use on cuts, abrasions, eczematous or sunburned skin. Avoid eyes, lips, mucous membranes, sun, UV light. Increased irritation in extreme weather. Pregnancy (Cat. C). Nursing mothers.
Interactions: : Caution with sulfur, resorcinol, salicylic acid, and other topical acne products. Avoid using concomitant topical irritants and waxing treated areas.
Adverse reactions: Local reactions (e.g., erythema, scaling, dryness, burning, stinging), contact dermatitis, skin irritation; may bleach fabrics or hair.
How supplied: Gel—45g
For more information, call 817.961.5000 or visit www.Epiduo.com.