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

April 20, 2022 updated by: Galderma R&D

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe Acne Vulgaris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Aibonito, Puerto Rico, 705
        • Galderma Investigational Site
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Galderma Investigational Site
      • Hot Springs, Arkansas, United States, 71913
        • Galderma Investigational Site
      • Rogers, Arkansas, United States, 72758
        • Galderma Investigational Site
    • California
      • Newport Beach, California, United States, 92663
        • Galderma Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Galderma Investigational Site
      • Boca Raton, Florida, United States, 33486
        • Galderma Investigational Site
      • Miramar, Florida, United States, 33027
        • Galderma Investigational Site
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Galderma Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Galderma Investigational Site
      • New Albany, Indiana, United States, 47150
        • Galderma Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Galderma Investigational Site
    • Michigan
      • Warren, Michigan, United States, 48088
        • Galderma Investigational Site
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Galderma Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Galderma Investigational Site
    • New York
      • Stony Brook, New York, United States, 11790
        • Galderma Investigational Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Galderma Investigational Site
    • Pennsylvania
      • Sugarloaf, Pennsylvania, United States, 18249
        • Galderma Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 71913
        • Galderma Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Galderma Investigational Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Galderma Investigational Site
      • Dallas, Texas, United States, 75246
        • Galderma Investigational Site
      • Grapevine, Texas, United States, 76051
        • Galderma Investigational Site
      • Pflugerville, Texas, United States, 78660
        • Galderma Investigational Site
      • San Antonio, Texas, United States, 78218
        • Galderma Investigational Site
      • San Antonio, Texas, United States, 78249
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe)
  • Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose
  • Agrees to provide written informed consent
  • Participant is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy)

Exclusion Criteria:

  • Participant with any acne cyst on the face
  • Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
  • Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
  • Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate
  • Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trifarotene Cream + Doxycycline
Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Drug: Trifarotene cream
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Other Names:
  • AKLIEF
Drug: Doxycycline hyclate
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Other Names:
  • DORYX MPC
Placebo Comparator: Trifarotene Vehicle + Doxycycline Placebo
Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
Time Frame: From Baseline to Week 12
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
From Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
Time Frame: From Baseline to Week 12
All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
From Baseline to Week 12
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
Time Frame: From Baseline to Week 12
Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
From Baseline to Week 12
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
Time Frame: From Baseline to Week 12
IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
From Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2020

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.202394

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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