Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
NCT ID: NCT04856904
Last Updated: 2024-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2021-05-28
2023-06-30
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
QUADRUPLE
Study Groups
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Trifarotene Vehicle Cream
Trifarotene Vehicle Cream
Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks
Trifarotene (CD5789) 50 mcg/g Cream
Trifarotene Cream
Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks
Interventions
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Trifarotene Cream
Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks
Trifarotene Vehicle Cream
Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
2. A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
3. No more than 2 nodules (greater than or equal to \[\>=\] 1 cm in diameter) on the face; and
4. A minimum of 10 atrophic acne scars in total (\>2 mm)
* Participant with a symmetrical number of the following lesions/scars on the whole face:
1. Inflammatory and non-inflammatory lesions; and
2. Atrophic acne scars (minimum of 4 scars per half-face)
* The participant is a female of non-childbearing potential
* If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
Exclusion Criteria
* Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
* Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
* Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
* Participant with known impaired hepatic or renal functions, based on medical history
17 Years
35 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 #8873
Scottsdale, Arizona, United States
Galderma Investigational Site #8447
Fort Smith, Arkansas, United States
Galderma Investigational Site #8608
Santa Monica, California, United States
Galderma Investigational Site #9928
Boynton Beach, Florida, United States
Galderma Investigational Site #8295
Miami, Florida, United States
Galderma Investigational Site #8883
Miramar, Florida, United States
Galderma Investigational Site #8189
Snellville, Georgia, United States
Galderma Investigational Site #8367
Arlington Heights, Illinois, United States
Galderma Investigational Site #8838
Darien, Illinois, United States
Galderma Investigational Site #8601
Metairie, Louisiana, United States
Galderma Investigational Site #9936
New Orleans, Louisiana, United States
Galderma Investigational Site #8108
Las Vegas, Nevada, United States
Galderma Investigational Site #8881
Stony Brook, New York, United States
Galderma Investigational Site #8886
Sugarloaf, Pennsylvania, United States
Galderma Investigational Site #9920
Arlington, Texas, United States
Galderma Investigational Site #9918
Peterborough, Ontario, Canada
Galderma Investigational Site #9927
Saint-Jérôme, Quebec, Canada
Galderma Investigational Site #6167
Nantes, , France
Countries
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References
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Schleicher S, Moore A, Rafal E, Gagne-Henley A, Johnson SM, Dhawan S, Chavda R, York JP, Sforzolini B, Holcomb K, Ablon G, Del Rosso J, Dreno B. Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study. Dermatol Ther (Heidelb). 2023 Dec;13(12):3085-3096. doi: 10.1007/s13555-023-01042-7. Epub 2023 Oct 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-006050-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RD.06.SPR.202395
Identifier Type: -
Identifier Source: org_study_id
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