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

NCT03522441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1125

Last updated 2020-10-05

Study results available
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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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Clindamycin 1% Gel

Topical gel

DRUG

Placebo

Topical Placebo gel

Sponsors & Collaborators

  • Akorn, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2019-04-22
Completion
2019-04-22
FDA Drug
Yes

Countries

  • United States
  • Belize

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522441 on ClinicalTrials.gov