A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
NCT ID: NCT04451330
Last Updated: 2022-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
202 participants
INTERVENTIONAL
2020-07-29
2021-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Trifarotene cream
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Doxycycline hyclate
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
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.
Trifarotene Vehicle
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
Doxycycline Placebo
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Interventions
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Trifarotene cream
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Doxycycline hyclate
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Trifarotene Vehicle
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
Doxycycline Placebo
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
12 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Investigational Site
Fort Smith, Arkansas, United States
Galderma Investigational Site
Hot Springs, Arkansas, United States
Galderma Investigational Site
Rogers, Arkansas, United States
Galderma Investigational Site
Newport Beach, California, United States
Galderma Investigational Site
Aventura, Florida, United States
Galderma Investigational Site
Boca Raton, Florida, United States
Galderma Investigational Site
Miramar, Florida, United States
Galderma Investigational Site
Newnan, Georgia, United States
Galderma Investigational Site
Evansville, Indiana, United States
Galderma Investigational Site
New Albany, Indiana, United States
Galderma Investigational Site
Rockville, Maryland, United States
Galderma Investigational Site
Warren, Michigan, United States
Galderma Investigational Site
New Brighton, Minnesota, United States
Galderma Investigational Site
Las Vegas, Nevada, United States
Galderma Investigational Site
Stony Brook, New York, United States
Galderma Investigational Site
High Point, North Carolina, United States
Galderma Investigational Site
Sugarloaf, Pennsylvania, United States
Galderma Investigational Site
Charleston, South Carolina, United States
Galderma Investigational Site
Knoxville, Tennessee, United States
Galderma Investigational Site
Arlington, Texas, United States
Galderma Investigational Site
Dallas, Texas, United States
Galderma Investigational Site
Grapevine, Texas, United States
Galderma Investigational Site
Pflugerville, Texas, United States
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
Aibonito, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.06.SPR.202394
Identifier Type: -
Identifier Source: org_study_id
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