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Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04856904
Recruitment Status : Active, not recruiting
First Posted : April 23, 2021
Last Update Posted : October 17, 2022
Information provided by (Responsible Party):
Galderma R&D

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
Acne Vulgaris Drug: Trifarotene Cream Drug: Trifarotene Vehicle Cream Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : March 10, 2023
Estimated Study Completion Date : May 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
Drug Information available for: Trifarotene

Arm Intervention/treatment
Placebo Comparator: Trifarotene Vehicle Cream 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

Experimental: Trifarotene (CD5789) 50 mcg/g Cream 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 Name: AKLIEF®

Primary Outcome Measures :
  1. Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half-Face to Week 20 [ Time Frame: Baseline upto Week 20 ]
  2. Total Atrophic Acne Scar Count Per Half-Face From Baseline to Week 24 [ Time Frame: Baseline upto Week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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]):

    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
  • Other protocol defined inclusion criteria could apply

Key Exclusion Criteria:

  • Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856904

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Sponsors and Collaborators
Galderma R&D
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT04856904    
Other Study ID Numbers: RD.06.SPR.202395
2020-006050-51 ( EudraCT Number )
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galderma R&D:
Acne vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dermatologic Agents