AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

NCT05089708 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: RD.06.SPR.2042452021-003608-41
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 25

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; Trifarotene; Aklief; CD5789

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24

  The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.

  Baseline and Week 24

Secondary Outcomes (3)

• Percent Change From Baseline in PIH ODS Scores at Week 24

  Baseline and Week 24

• Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20

  Baseline, at Week 12, Week 16 and Week 20

• Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20

  Baseline, at Week 12, Week 16 and Week 20

Study Arms (2)

Trifarotene (CD5789) 50 mcg/g Cream

EXPERIMENTAL

Drug: Trifarotene Cream

Trifarotene Vehicle Cream

PLACEBO COMPARATOR

Drug: Trifarotene Vehicle Cream

Interventions

Trifarotene Cream DRUG

Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks

Also known as: Aklief

Trifarotene (CD5789) 50 mcg/g Cream

Trifarotene Vehicle Cream DRUG

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

Trifarotene Vehicle Cream

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant with clinical diagnosis of acne vulgaris, defined by:
• moderate acne on the face (acne Investigator's Global Assessment \[IGA\] =3); and
• with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose); and
• moderate to marked PIH on the face (Overview of Pigmentation Disorders hyperpigmentation scale 4-6); and
• no more than one acne nodule or cyst (greater than \[\>\] 1 centimeter \[cm\]) on face (excluding the nose)
• Participant with any Fitzpatrick Skin Type I to VI (target patient enrollment according to FST)
• Female participants of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit
• Female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study
• Female participant of non-childbearing potential

You may not qualify if:

• Participant with severe acne (IGA \> 3)
• Participant with more than 1 nodule/cyst on the face (excluding the nose)
• Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne, acne requiring systemic treatment
• Participant with damaged facial skin that may interfere with study assessments
• Female participant who is pregnant, lactating or planning a pregnancy during the study
• Female participant of childbearing potential using combined oral contraceptives approved as acne treatments, in whom the dose has not been stable for at least 6 months prior to the Baseline visit
• Participant with known impaired hepatic or renal functions
• Participant with active or chronic skin allergies

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (25)

Galderma Investigational Site #8636

Fountain Valley, California, 92708, United States

Location

Galderma Investigational Site #8224

Fremont, California, 94538, United States

Location

Galderma Investigational Site #8358

San Diego, California, 92108, United States

Location

Galderma Investigational Site #9955

San Diego, California, 92123, United States

Location

Galderma Investigational Site #7012

Lutz, Florida, 33549, United States

Location

Galderma Investigational Site #8184

Maitland, Florida, 32751, United States

Location

Galderma Investigational Site #8764

Tampa, Florida, 33613, United States

Location

Galderma Investigational Site #9950

Evansville, Indiana, 47714, United States

Location

Galderma Investigational Site #9952

Baton Rouge, Louisiana, 70808, United States

Location

Galderma Investigational Site #8606

New Orleans, Louisiana, 70115, United States

Location

Galderma Investigational Site #8012

Glenn Dale, Maryland, 20769, United States

Location

Galderma Investigational Site #9948

Hyattsville, Maryland, 20782, United States

Location

Galderma Investigational Site #8554

Detroit, Michigan, 48202, United States

Location

Galderma Investigational Site #8108

Las Vegas, Nevada, 89148, United States

Location

Galderma Investigational Site #8620

New York, New York, 10025, United States

Location

Galderma Investigational Site #9956

New York, New York, 10025, United States

Location

Galderma Investigational Site #9949

New York, New York, 10155, United States

Location

Galderma Investigational Site #9953

Tulsa, Oklahoma, 74133, United States

Location

Galderma Investigational Site #8207

Nashville, Tennessee, 37215, United States

Location

Galderma Investigational Site #9920

Arlington, Texas, 76011, United States

Location

Galderma Investigational Site #8329

San Antonio, Texas, 78229, United States

Location

Galderma Investigational Site #8433

San Antonio, Texas, 78229, United States

Location

Galderma Investigational Site #6192

Zaragoza, Aragon, 50009, Spain

Location

Galderma Investigational Site #6278

Manises, Valencia, 46940, Spain

Location

Galderma Investigational Site #6277

Pontevedra, 36071, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Clinical Scientist
• Organization: Galderma

reception.seupp@galderma.com

+46184749000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: December 22, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Locations

US (22); ES (3)