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

• Status: Completed
• Trial end date: 2020-04-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited; Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Treatments: Adapalene; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

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