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

NCT04321070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2025-04-10

No results posted yet for this study

Summary

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

Conditions

  • Acne Vulgaris

Interventions

DRUG

Clindamycin Phosphate

A thin film of investigation product will be applied to the affected areas of the face once daily

DRUG

Clindamycin Phosphate RLD

A thin film of investigation product will be applied to the affected areas of the face once daily

DRUG

Placebos

A thin film of investigation product will be applied to the affected areas of the face once daily

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Natalie Yantovskiy · Taro Pharmaceuticals, Inc.

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
2019-09-09
Primary Completion
2019-12-14
Completion
2020-03-06
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 NCT04321070 on ClinicalTrials.gov