AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Acne Vulgaris Clinical Trial

— LEAP  

Official title:

Evaluation of Acne-induced Hyperpigmentation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089708
• Other study ID #: RD.06.SPR.204245
• Secondary ID: 2021-003608-41
• Status: Completed
• Phase: Phase 4
• Start date: December 22, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: December 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

Key Inclusion Criteria:

• Participant with clinical diagnosis of acne vulgaris, defined by:

1. moderate acne on the face (acne Investigator's Global Assessment [IGA] =3); and

2. with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose); and

3. moderate to marked PIH on the face (Overview of Pigmentation Disorders hyperpigmentation scale 4-6); and

4. 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

• Other protocol defined inclusion criteria could apply

Key Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acne Vulgaris
• Hyperpigmentation

Intervention

Drug:
• Trifarotene Cream
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
• Trifarotene Vehicle Cream
Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks

Locations

Country	Name	City	State
Spain	Galderma Investigational Site #6278	Manises	Valencia
Spain	Galderma Investigational Site #6277	Pontevedra
Spain	Galderma Investigational Site #6192	Zaragoza	Aragon
United States	Galderma Investigational Site #9920	Arlington	Texas
United States	Galderma Investigational Site #9952	Baton Rouge	Louisiana
United States	Galderma Investigational Site #8554	Detroit	Michigan
United States	Galderma Investigational Site #9950	Evansville	Indiana
United States	Galderma Investigational Site #8636	Fountain Valley	California
United States	Galderma Investigational Site #8224	Fremont	California
United States	Galderma Investigational Site #8012	Glenn Dale	Maryland
United States	Galderma Investigational Site #9948	Hyattsville	Maryland
United States	Galderma Investigational Site #8108	Las Vegas	Nevada
United States	Galderma Investigational Site #7012	Lutz	Florida
United States	Galderma Investigational Site #8184	Maitland	Florida
United States	Galderma Investigational Site #8207	Nashville	Tennessee
United States	Galderma Investigational Site #8606	New Orleans	Louisiana
United States	Galderma Investigational Site #8620	New York	New York
United States	Galderma Investigational Site #9949	New York	New York
United States	Galderma Investigational Site #9956	New York	New York
United States	Galderma Investigational Site #8329	San Antonio	Texas
United States	Galderma Investigational Site #8433	San Antonio	Texas
United States	Galderma Investigational Site #8358	San Diego	California
United States	Galderma Investigational Site #9955	San Diego	California
United States	Galderma Investigational Site #8764	Tampa	Florida
United States	Galderma Investigational Site #9953	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and Week 24
Secondary	Percent Change From Baseline in PIH ODS Scores at Week 24	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but	Baseline and Week 24
Secondary	Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but	Baseline, at Week 12, Week 16 and Week 20
Secondary	Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but	Baseline, at Week 12, Week 16 and Week 20