Clinical trial NCT03615768: A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
Collaborators: name: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
First posted: 2018-08-06
Enrollment: 1617
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage Change From Baseline in Total Lesion Counts
timeFrame: Week 12
measure: Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline
timeFrame: Week 12
Secondary outcomes:
measure: Percentage change from baseline in inflammatory lesion counts
timeFrame: Week 12
measure: Percentage change from baseline in non-inflammatory lesion counts
timeFrame: Week 12
measure: Change from baseline in inflammatory lesion counts
timeFrame: Week 12
measure: Change from baseline in non-inflammatory lesion counts
timeFrame: Week 12
measure: Change from baseline in total lesion counts
timeFrame: Week 12
measure: Change from baseline in Investigator's Global Assessment (IGA)
timeFrame: Week 12
measure: Treatment success rate
timeFrame: Week 12
Other outcomes:
measure: Local Adverse Reactions
timeFrame: Week 2, Week 4, Week 8 and Week 12
Locations:
city: Nanjing
country: China
facility: Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
state: Jiangsu
Study officials:
affiliation: Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
name: Heng Gu, MD
role: PRINCIPAL_INVESTIGATOR
References: