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Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

NCT04134273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2019-10-22

No results posted yet for this study

Summary

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

CLPG Topical Gel 1%

Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)

DRUG

Clindamycin

Clindamycin Phosphate topical gel 1%

DRUG

Placebo

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, 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
2019-03-20
Primary Completion
2019-09-17
Completion
2019-10-15

Countries

  • United States

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 NCT04134273 on ClinicalTrials.gov