Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522441
• Other study ID #: CLMG 1711
• Status: Completed
• Phase: Phase 3
• Start date: April 27, 2018
• Est. completion date: April 22, 2019

Study information

• Verified date: May 2018
• Source: Akorn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1125
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

IInclusion Criteria:

• Male or non-pregnant, non-lactating female, =12 and =40 years of age with a clinical diagnosis of acne vulgaris.

• Have facial acne with: =20 facial inflammatory lesions (papules and pustules) and =25 non-inflammatory lesions (open and closed comedones), and =2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

• Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.

• Subject has active cystic acne.

• Subject has acne conglobata.

• Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Clindamycin 1% Gel
Topical gel
• Placebo
Topical Placebo gel

Locations

Country	Name	City	State
Belize	Site 6	Belize City
Belize	Site 7	Belize City
United States	Site 1	Brandon	Florida
United States	Site 8	El Paso	Texas
United States	Site 9	El Paso	Texas
United States	Site 11	Encino	California
United States	Site 12	High Point	North Carolina
United States	Site 4	Miramar	Florida
United States	Site 5	Miramar	Florida
United States	Site 10	Sherman Oaks	California
United States	Site 2	Tampa	Florida
United States	Site 3	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Akorn, Inc.

Countries where clinical trial is conducted

United States,  Belize, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks		Percent change from baseline to 12 weeks
Primary	Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week		Percent change in baseline to 12 weeks