Manufacturer:

Coria Laboratories and Arcutis

Pharmacological Class:

Lincosamide antibiotic + antibacterial/keratolytic

Active Ingredient(s):

Clindamycin (as phosphate) 1.2%, benzoyl peroxide 2.5%; gel.

Indication(s):

Topical treatment of acne vulgaris.

Pharmacology:

Acanya gel combines the lincosamide antibiotic, clindamycin, with the oxidizing agent, benzoyl peroxide, in a topical aqueous gel. Clindamycin exerts its antimicrobial effect by binding to the 50S subunit on susceptible microorganisms, thereby interfering with bacterial protein synthesis. Benzoyl peroxide is absorbed into the skin where it is converted to benzoic acid. These drugs have each been shown to have in vitro activity against Propionibacterium acnes, which has been associated with the development of acne vulgaris; the clinical significance of this is unknown.

Clinical Trials:

Two 12-week multicenter, randomized, double-blind studies were conducted to assess the safety and efficacy of the once-daily use of Acanya in treating moderate to severe acne vulgaris in 2813 patients, using identical protocols. Acanya gel was compared to clindamycin gel, benzoyl peroxide gel, and the vehicle gel alone. The studies examined the mean absolute change in baseline at Week 12 in inflammatory lesion counts and noninflammatory lesion counts, and the percentage of patients who had a 2-grade improvement from baseline in an Evaluator Global Severity Score (EGSS). The EGSS ranges from 0 (clear) to 5 (very severe) and all patients had a score of 3 (moderate) or 4 (severe) at baseline. Study 1: By Week 12, the mean percent reductions in inflammatory lesions with Acanya were 55% compared to 34.5% of those using vehicle alone. The mean percent reductions in noninflammatory lesions with Acanya were 45.3% compared to 28.6% for vehicle only. Approximately 33% of patients on Acanya had a 2-grade improvement in EGSS (treatment success) by Week 12 compared to 19% on vehicle. Furthermore, investigators judged 29% of patients on Acanya to be ‘clear/almost clear’ at Week 12 compared to only 14% on vehicle. Study 2: By Week 12, the mean percent reductions in inflammatory lesions with Acanya were 54.2% compared to 23.3% for vehicle alone. The mean percent reductions in noninflammatory lesions with Acanya were 41.2% compared to 19.2% for vehicle only. Approximately 37% of patients on Acanya had a 2-grade improvement in EGSS (treatment success) by Week 12 compared to 14% on vehicle. Furthermore, investigators judged 28% of patients on Acanya to be ‘clear/almost clear’ at Week 12 compared to only 11% on vehicle. The use of Acanya gel beyond 12 weeks has not been evaluated.

Legal Classification:

Rx

Adults:

Wash and dry skin. Apply a small (pea-sized) amount in a thin layer to the face once daily. Wash hands after use.

Children:

Not recommended.

Warnings/Precautions:

Avoid eyes, mucous membranes, broken skin, sun, UV light. Discontinue if significant diarrhea occurs. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interaction(s):

Avoid concomitant erythro-mycin. Additive irritation with other topical acne products. May potentiate neuromuscular blocking agents.

Adverse Reaction(s):

Application site pain, exfoliation, irritation; may bleach fabrics or hair; rare: superinfection, colitis.

How Supplied:

Gel—50g

Last Updated:

3/6/2009