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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1617 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2020-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne

NCT02593383

Acne

COMPLETED PHASE1/PHASE2

Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

NCT00441415

Acne Vulgaris

COMPLETED PHASE3

Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris

NCT02721173

Acne Vulgaris

COMPLETED PHASE4

Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

NCT00926367

Acne Vulgaris

COMPLETED PHASE4

Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

NCT02411942

Acne Vulgaris

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adapalene-Clindamycin Combination Gel

Group Type EXPERIMENTAL

Adapalene-Clindamycin Combination Gel

Intervention Type COMBINATION_PRODUCT

5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks

Adapalene Gel

Group Type ACTIVE_COMPARATOR

Adapalene Gel

Intervention Type DRUG

Differin 0.1% Gel, applied nightly for 12 weeks

Clindamycin Gel

Group Type ACTIVE_COMPARATOR

Clindamycin Gel

Intervention Type DRUG

Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adapalene-Clindamycin Combination Gel

5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks

Intervention Type COMBINATION_PRODUCT

Adapalene Gel

Differin 0.1% Gel, applied nightly for 12 weeks

Intervention Type DRUG

Clindamycin Gel

Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Differin Clindamycin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No