Status:
COMPLETED
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04451330
Start Date
July 29 2020
End Date
April 26 2021
Last Update
May 10 2022
Active Locations (26)
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1
Galderma Investigational Site
Fort Smith, Arkansas, United States, 72916
2
Galderma Investigational Site
Hot Springs, Arkansas, United States, 71913
3
Galderma Investigational Site
Rogers, Arkansas, United States, 72758
4
Galderma Investigational Site
Newport Beach, California, United States, 92663