NCT04856904

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2021

Typical duration for phase_4

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 11, 2024

Completed
Last Updated

June 11, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

April 20, 2021

Results QC Date

March 15, 2024

Last Update Submit

June 10, 2024

Conditions

Acne Vulgaris

Keywords

Acne vulgarisTrifaroteneAKLIEF®CD5789

Outcome Measures

Primary Outcomes (1)

  • Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24

    The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

    Baseline, Week 24

Secondary Outcomes (1)

  • Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20

    Baseline, up to Week 20

Study Arms (2)

Trifarotene Vehicle Cream

PLACEBO COMPARATOR
Drug: Trifarotene Vehicle Cream

Trifarotene (CD5789) 50 mcg/g Cream

EXPERIMENTAL
Drug: Trifarotene Cream

Interventions

Trifarotene CreamDRUG

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

Also known as: AKLIEF®
Trifarotene (CD5789) 50 mcg/g Cream
Trifarotene Vehicle CreamDRUG

Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks

Trifarotene Vehicle Cream

Eligibility Criteria

Age17 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Galderma Investigational Site #8873

Scottsdale, Arizona, 85260, United States

Location

Galderma Investigational Site #8447

Fort Smith, Arkansas, 72916, United States

Location

Galderma Investigational Site #8608

Santa Monica, California, 90404, United States

Location

Galderma Investigational Site #9928

Boynton Beach, Florida, 33437, United States

Location

Galderma Investigational Site #8295

Miami, Florida, 33136, United States

Location

Galderma Investigational Site #8883

Miramar, Florida, 33027, United States

Location

Galderma Investigational Site #8189

Snellville, Georgia, 30078, United States

Location

Galderma Investigational Site #8367

Arlington Heights, Illinois, 60005, United States

Location

Galderma Investigational Site #8838

Darien, Illinois, 60561, United States

Location

Galderma Investigational Site #8601

Metairie, Louisiana, 70001, United States

Location

Galderma Investigational Site #9936

New Orleans, Louisiana, 70130, United States

Location

Galderma Investigational Site #8108

Las Vegas, Nevada, 89148, United States

Location

Galderma Investigational Site #8881

Stony Brook, New York, 11790, United States

Location

Galderma Investigational Site #8886

Sugarloaf, Pennsylvania, 18249, United States

Location

Galderma Investigational Site #9920

Arlington, Texas, 76011, United States

Location

Galderma Investigational Site #9918

Peterborough, Ontario, Canada

Location

Galderma Investigational Site #9927

Saint-Jérôme, Quebec, Canada

Location

Galderma Investigational Site #6167

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 37838987DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Clinical Scientist
Organization
Galderma R&D, Inc.
reception.seupp@galderma.com
+46184749000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 23, 2021

Study Start

May 28, 2021

Primary Completion

February 8, 2023

Study Completion

June 30, 2023

Last Updated

June 11, 2024

Results First Posted

June 11, 2024

Record last verified: 2023-12

Locations

CA(2)FR(1)US(15)