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A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

NCT04451330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-05-10

Study results available
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Summary

The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Trifarotene cream

Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.

DRUG

Doxycycline hyclate

Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.

DRUG

Trifarotene Vehicle

Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.

DRUG

Doxycycline Placebo

Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-04-26
Completion
2021-04-26
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

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 NCT04451330 on ClinicalTrials.gov