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

Completed · Phase 4 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT04451330

Run by

Galderma R&D

People needed

202

Starts

2020-07-29

Expected to finish

2021-04-26

Last updated by the study team

2022-05-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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