Clinical trial NCT04856904: Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Trifarotene
AKLIEF®
CD5789
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 121
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 \[cm\]):

  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

Primary outcomes:
measure: Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
timeFrame: Baseline, up to Week 20
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Galderma Investigational Site #8873
state: Arizona
city: Fort Smith
country: United States
facility: Galderma Investigational Site #8447
state: Arkansas
city: Santa Monica
country: United States
facility: Galderma Investigational Site #8608
state: California
city: Boynton Beach
country: United States
facility: Galderma Investigational Site #9928
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site #8295
state: Florida
city: Miramar
country: United States
facility: Galderma Investigational Site #8883
state: Florida
city: Snellville
country: United States
facility: Galderma Investigational Site #8189
state: Georgia
city: Arlington Heights
country: United States
facility: Galderma Investigational Site #8367
state: Illinois
city: Darien
country: United States
facility: Galderma Investigational Site #8838
state: Illinois
city: Metairie
country: United States
facility: Galderma Investigational Site #8601
state: Louisiana
city: New Orleans
country: United States
facility: Galderma Investigational Site #9936
state: Louisiana
city: Las Vegas
country: United States
facility: Galderma Investigational Site #8108
state: Nevada
city: Stony Brook
country: United States
facility: Galderma Investigational Site #8881
state: New York
city: Sugarloaf
country: United States
facility: Galderma Investigational Site #8886
state: Pennsylvania
city: Arlington
country: United States
facility: Galderma Investigational Site #9920
state: Texas
city: Peterborough
country: Canada
facility: Galderma Investigational Site #9918
state: Ontario
city: Saint-Jérôme
country: Canada
facility: Galderma Investigational Site #9927
state: Quebec
city: Nantes
country: France
facility: Galderma Investigational Site #6167
Study officials:
References: