START: Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Trifarotene Vehicle Cream
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Drug: 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
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Experimental: Trifarotene (CD5789) 50 mcg/g Cream
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Drug: 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24 [Baseline, Week 24]
Secondary Outcome Measures
- Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half-Face to Week 20 [Baseline upto Week 20]
- Total Atrophic Acne Scar Count Per Half-Face From Baseline to Week 24 [Baseline upto Week 24]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
- Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):
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Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
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A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
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No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face; and
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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:
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Inflammatory and non-inflammatory lesions; and
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Atrophic acne scars (minimum of 4 scars per half-face)
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The participant is a female of non-childbearing potential
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If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
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Other protocol defined inclusion criteria could apply
Key Exclusion Criteria:
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Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
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Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
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Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
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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
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Participant with known impaired hepatic or renal functions, based on medical history
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Galderma Investigational Site #8873 | Scottsdale | Arizona | United States | 85260 |
2 | Galderma Investigational Site #8447 | Fort Smith | Arkansas | United States | 72916 |
3 | Galderma Investigational Site #8608 | Santa Monica | California | United States | 90404 |
4 | Galderma Investigational Site #9928 | Boynton Beach | Florida | United States | 33437 |
5 | Galderma Investigational Site #8295 | Miami | Florida | United States | 33136 |
6 | Galderma Investigational Site #8883 | Miramar | Florida | United States | 33027 |
7 | Galderma Investigational Site #8189 | Snellville | Georgia | United States | 30078 |
8 | Galderma Investigational Site #8367 | Arlington Heights | Illinois | United States | 60005 |
9 | Galderma Investigational Site #8838 | Darien | Illinois | United States | 60561 |
10 | Galderma Investigational Site #8601 | Metairie | Louisiana | United States | 70001 |
11 | Galderma Investigational Site #9936 | New Orleans | Louisiana | United States | 70130 |
12 | Galderma Investigational Site #8108 | Las Vegas | Nevada | United States | 89148 |
13 | Galderma Investigational Site #8881 | Stony Brook | New York | United States | 11790 |
14 | Galderma Investigational Site #8886 | Sugarloaf | Pennsylvania | United States | 18249 |
15 | Galderma Investigational Site #9920 | Arlington | Texas | United States | 76011 |
16 | Galderma Investigational Site #9918 | Peterborough | Ontario | Canada | |
17 | Galderma Investigational Site #9927 | Saint-Jérôme | Quebec | Canada | |
18 | Galderma Investigational Site #6167 | Nantes | France | 44093 |
Sponsors and Collaborators
- Galderma R&D
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD.06.SPR.202395
- 2020-006050-51