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NCT03522441 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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