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
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
1 other identifier
interventional
202
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2020
Shorter than P25 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2021
CompletedResults Posted
Study results publicly available
May 10, 2022
CompletedMay 10, 2022
April 1, 2021
9 months
June 25, 2020
April 20, 2022
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Facial Total Lesion Counts 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 Outcomes (3)
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
From Baseline to Week 12
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
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
From Baseline to Week 12
Study Arms (2)
Trifarotene Cream + Doxycycline
EXPERIMENTALParticipants 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.
Trifarotene Vehicle + Doxycycline Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (26)
Galderma Investigational Site
Fort Smith, Arkansas, 72916, United States
Galderma Investigational Site
Hot Springs, Arkansas, 71913, United States
Galderma Investigational Site
Rogers, Arkansas, 72758, United States
Galderma Investigational Site
Newport Beach, California, 92663, United States
Galderma Investigational Site
Aventura, Florida, 33180, United States
Galderma Investigational Site
Boca Raton, Florida, 33486, United States
Galderma Investigational Site
Miramar, Florida, 33027, United States
Galderma Investigational Site
Newnan, Georgia, 30263, United States
Galderma Investigational Site
Evansville, Indiana, 47715, United States
Galderma Investigational Site
New Albany, Indiana, 47150, United States
Galderma Investigational Site
Rockville, Maryland, 20850, United States
Galderma Investigational Site
Warren, Michigan, 48088, United States
Galderma Investigational Site
New Brighton, Minnesota, 55112, United States
Galderma Investigational Site
Las Vegas, Nevada, 89148, United States
Galderma Investigational Site
Stony Brook, New York, 11790, United States
Galderma Investigational Site
High Point, North Carolina, 27262, United States
Galderma Investigational Site
Sugarloaf, Pennsylvania, 18249, United States
Galderma Investigational Site
Charleston, South Carolina, 71913, United States
Galderma Investigational Site
Knoxville, Tennessee, 37922, United States
Galderma Investigational Site
Arlington, Texas, 76011, United States
Galderma Investigational Site
Dallas, Texas, 75246, United States
Galderma Investigational Site
Grapevine, Texas, 76051, United States
Galderma Investigational Site
Pflugerville, Texas, 78660, United States
Galderma Investigational Site
San Antonio, Texas, 78218, United States
Galderma Investigational Site
San Antonio, Texas, 78249, United States
Galderma Investigational Site
Aibonito, 705, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Galderma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2020
First Posted
June 30, 2020
Study Start
July 29, 2020
Primary Completion
April 26, 2021
Study Completion
April 26, 2021
Last Updated
May 10, 2022
Results First Posted
May 10, 2022
Record last verified: 2021-04