A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris

A Multi-center, Randomized, Single-blind, Paralelle, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Moderate Acne Vulgaris

This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.

Inclusion Criteria:

• Male or female, aged 12-40 years old
• Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
• Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.

Exclusion Criteria:

• Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
• Secondary Acne, such as occupational acne and steroid acne
• Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
• History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
• History of serious heart disease or hypertension
• Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
• Serious endocrine, hematologic or psychiatric disease
• Known immunocompromised conditions, or require long-term steroids or immunosuppressants
• Females who are pregnant, lactating, or not willing to use effective contraception
• Drug or alcohol abuse
• Used any topical acne treatment within 2 weeks
• Used any systemic retinoid, antibiotic or other acne treatment
• Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
• Patient who the investigator deemed to be unsuitable for any reason