Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Galderma R&D

Conditions:

Acne Vulgaris

Eligibility:

All Genders

17-35 years

Phase:

PHASE4

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 wee...

Eligibility Criteria

Inclusion

  • Key
  • Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter \[cm\]):
  • Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
  • A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
  • No more than 2 nodules (greater than or equal to \[\>=\] 1 cm in diameter) on the face; and
  • 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:
  • Inflammatory and non-inflammatory lesions; and
  • 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

  • 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

Key Trial Info

Start Date :

May 28 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2023

Estimated Enrollment :

121 Patients enrolled

Trial Details

Trial ID

NCT04856904

Start Date

May 28 2021

End Date

June 30 2023

Last Update

June 11 2024

Active Locations (18)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (18 locations)

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