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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615768
• Other study ID #: ZK-ACG-201712
• Status: Completed
• Phase: Phase 3
• Start date: August 14, 2018
• Est. completion date: April 7, 2020

Study information

• Verified date: April 2020
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1617
• Est. completion date: April 7, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Combination Product:
• Adapalene-Clindamycin Combination Gel
5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks

Drug:
• Adapalene Gel
Differin 0.1% Gel, applied nightly for 12 weeks
• Clindamycin Gel
Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks

Locations

Country	Name	City	State
China	Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local Adverse Reactions	Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity	Week 2, Week 4, Week 8 and Week 12
Primary	Percentage Change From Baseline in Total Lesion Counts	Percent change from Baseline in total lesions counts in each treatment group at Week 12.	Week 12
Primary	Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline		Week 12
Secondary	Percentage change from baseline in inflammatory lesion counts	Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.	Week 12
Secondary	Percentage change from baseline in non-inflammatory lesion counts	Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.	Week 12
Secondary	Change from baseline in inflammatory lesion counts	Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.	Week 12
Secondary	Change from baseline in non-inflammatory lesion counts	Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.	Week 12
Secondary	Change from baseline in total lesion counts	Absolute change from baseline in total lesions counts in each treatment group at Week 12.	Week 12
Secondary	Change from baseline in Investigator's Global Assessment (IGA)	Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.	Week 12
Secondary	Treatment success rate	The proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)"; if IGA score at baseline is 2, success is only achieved if IGA score is 0 at Week 12.	Week 12