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AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (LEAP)

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Trifarotene Cream
Trifarotene Vehicle Cream
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Trifarotene, Aklief, CD5789

Eligibility Criteria

13 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 [ODS] 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

Sites / Locations

  • Galderma Investigational Site #8636
  • Galderma Investigational Site #8224
  • Galderma Investigational Site #8358
  • Galderma Investigational Site #9955
  • Galderma Investigational Site #7012
  • Galderma Investigational Site #8184
  • Galderma Investigational Site #8764
  • Galderma Investigational Site #9950
  • Galderma Investigational Site #9952
  • Galderma Investigational Site #8606
  • Galderma Investigational Site #8012
  • Galderma Investigational Site #9948
  • Galderma Investigational Site #8554
  • Galderma Investigational Site #8108
  • Galderma Investigational Site #8620
  • Galderma Investigational Site #9956
  • Galderma Investigational Site #9949
  • Galderma Investigational Site #9953
  • Galderma Investigational Site #8207
  • Galderma Investigational Site #9920
  • Galderma Investigational Site #8329
  • Galderma Investigational Site #8433
  • Galderma Investigational Site #6192
  • Galderma Investigational Site #6278
  • Galderma Investigational Site #6277

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trifarotene (CD5789) 50 mcg/g Cream

Trifarotene Vehicle Cream

Arm Description

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity Scores at Week 24
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.

Secondary Outcome Measures

Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 24
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
Absolute Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.

Full Information

First Posted
October 11, 2021
Last Updated
December 19, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT05089708
Brief Title
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 vulagris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, Trifarotene, Aklief, CD5789

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trifarotene (CD5789) 50 mcg/g Cream
Arm Type
Experimental
Arm Title
Trifarotene Vehicle Cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Trifarotene Cream
Other Intervention Name(s)
Aklief
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Trifarotene Vehicle Cream
Intervention Description
Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity Scores at Week 24
Description
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 24
Description
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
Time Frame
Baseline upto Week 24
Title
Absolute Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20
Description
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
Time Frame
Baseline, Week 12, Week 16 and Week 20
Title
Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20
Description
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
Time Frame
Baseline, Week 12, Week 16 and Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 [ODS] 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 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
Facility Information:
Facility Name
Galderma Investigational Site #8636
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Galderma Investigational Site #8224
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Galderma Investigational Site #8358
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Galderma Investigational Site #9955
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Galderma Investigational Site #7012
City
Lutz
State/Province
Florida
ZIP/Postal Code
33549
Country
United States
Facility Name
Galderma Investigational Site #8184
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Galderma Investigational Site #8764
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Galderma Investigational Site #9950
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Galderma Investigational Site #9952
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Galderma Investigational Site #8606
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Galderma Investigational Site #8012
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Facility Name
Galderma Investigational Site #9948
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Galderma Investigational Site #8554
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Galderma Investigational Site #8108
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Galderma Investigational Site #8620
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Galderma Investigational Site #9956
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Galderma Investigational Site #9949
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Galderma Investigational Site #9953
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Galderma Investigational Site #8207
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Galderma Investigational Site #9920
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Galderma Investigational Site #8329
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Galderma Investigational Site #8433
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Galderma Investigational Site #6192
City
Zaragoza
State/Province
Aragon
ZIP/Postal Code
50009
Country
Spain
Facility Name
Galderma Investigational Site #6278
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Galderma Investigational Site #6277
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

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