Marketing Information
- EVOCLIN was approved by the U.S. Food and Drug Administration on October 22, 2004.
- EVOCLIN is marketed directly to physicians and health care professionals by Connetics Corporation.
- Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market.
About EVOCLIN
- EVOCLIN is a once-a-day topical antibiotic in a temperature sensitive foam vehicle (VersaFoam®), for the treatment of acne vulgaris.
- The novel foam formulation, used once-a-day, is easy to apply and leaves minimal to no residue-characteristics that make it easy to spread on multiple body areas that are affected.
How it Works
- EVOCLIN should be applied once daily, covering the affected areas after the skin is washed with mild soap and allowed to fully dry.
- Clindamycin, the antibiotic in EVOCLIN, reduces redness and the growth of P. acnes, the bacteria that leads to acne.
EVOCLIN Clinical Data
- The clinical data supporting FDA approval of EVOCLIN resulted from a randomized, double-blinded, multi-center trial of more than 1,000 patients age 12 and older. In the non-inferiority study the results indicated that EVOCLIN produced a reduction in total lesions by 43% (n=386) versus 36% (n=385) for the reference listed drug clindamycin phosphate gel 1% and 31% (n=127) for vehicle foam (placebo), (p <0.05 for all values).
- Adverse events were mild to moderate in nature; the most common events were headache (3%) and application site reactions including burning (6%), itching (1%) and dryness (1%).
Safety Information
- Side effects can occur when using any acne product, including EVOCLIN. Side effects may include burning, itching, dryness, or headache.
- EVOCLIN is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, or a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. Diarrhea, bloody diarrhea, and pseudomembranous colitis have been reported with systemic and rarely with topical clindamycin. Discontinuation is recommended if diarrhea develops.