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Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

NCT03717506 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1236

Last updated 2021-05-04

Study results available
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Summary

The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

GDC 268 Lotion

GDC 268 is a topical lotion

DRUG

Clindamycin Phosphate Lotion 1%

Clindamycin Phosphate Lotion is an FDA-approved drug product

DRUG

GDC Vehicle Lotion

GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs

Sponsors & Collaborators

  • Balmoral Medical company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2020-02-17
Completion
2020-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03717506 on ClinicalTrials.gov