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

Lee's Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Clindamycin Gel

Combination Product: Adapalene-Clindamycin Combination Gel

Drug: Adapalene Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT03615768

ZK-ACG-201712

Details and patient eligibility

About

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.

Enrollment

1,617 patients

Sex

All

Ages

12 to 40 years old

Volunteers

No Healthy Volunteers

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