Acne VulgarisPhase 4LEAPNCT05089708

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

A Phase 4 study testing Trifarotene Cream in people with Acne Vulgaris, run by Galderma R&D at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Ages 13 to 35 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Trifarotene Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 123 participants
Where: 25 sitesin 2 countries
Study dates: 22 Dec 2021to 15 Dec 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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)

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States22 sites

Galderma Investigational Site #9920
Arlington, Texas, 76011
Galderma Investigational Site #9952
Baton Rouge, Louisiana, 70808
Galderma Investigational Site #8554
Detroit, Michigan, 48202
Galderma Investigational Site #9950
Evansville, Indiana, 47714
Galderma Investigational Site #8636
Fountain Valley, California, 92708
Galderma Investigational Site #8224
Fremont, California, 94538
Galderma Investigational Site #8012
Glenn Dale, Maryland, 20769
Galderma Investigational Site #9948
Hyattsville, Maryland, 20782
Galderma Investigational Site #8108
Las Vegas, Nevada, 89148
Galderma Investigational Site #7012
Lutz, Florida, 33549
Galderma Investigational Site #8184
Maitland, Florida, 32751
Galderma Investigational Site #8207
Nashville, Tennessee, 37215
Galderma Investigational Site #8606
New Orleans, Louisiana, 70115
Galderma Investigational Site #8620
New York, New York, 10025
Galderma Investigational Site #9956
New York, New York, 10025
Galderma Investigational Site #9949
New York, New York, 10155
Galderma Investigational Site #8329
San Antonio, Texas, 78229
Galderma Investigational Site #8433
San Antonio, Texas, 78229
Galderma Investigational Site #8358
San Diego, California, 92108
Galderma Investigational Site #9955
San Diego, California, 92123
Galderma Investigational Site #8764
Tampa, Florida, 33613
Galderma Investigational Site #9953
Tulsa, Oklahoma, 74133

Other trials in United States

Spain3 sites

Galderma Investigational Site #6278
Manises, Valencia, 46940
Galderma Investigational Site #6277
Pontevedra, 36071
Galderma Investigational Site #6192
Zaragoza, Aragon, 50009

Other trials in Spain

About this study

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

Conditions: Acne Vulgaris
Being tested: Trifarotene Cream, Trifarotene Vehicle Cream
Keywords: Acne vulgaris, Trifarotene, Aklief, CD5789
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05089708
Study group	Role	What they receive
Trifarotene (CD5789) 50 mcg/g Cream	Experimental	Not described Receives: Drug: Trifarotene Cream
Trifarotene Vehicle Cream	Placebo comparator	Not described Receives: Drug: Trifarotene Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 24

Secondary outcomes (3)

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 <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.
Measured: Baseline and Week 24
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 <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.
Measured: 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
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.
Measured: Baseline, at Week 12, Week 16 and Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 202115 Dec 2022

First posted22 Oct 2021
Study start22 Dec 2021
Primary completion15 Dec 2022
Study completion15 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05089708
Sponsor's protocol ID: RD.06.SPR.204245
Other IDs: 2021-003608-41
Acronym: LEAP
Status last verified: Dec 2023
First submitted: 11 Oct 2021
Last updated: 20 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Dias-Barbosa C, Taylor N, Chan K, York JP, Puelles J, Chavda R. Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings. Patient. 2026 Mar;19(2):343-352. doi: 10.1007/s40271-025-00789-9. Epub 2025 Nov 24.
PubMed 41286546

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
RecruitingPhase 1
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Acne

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05089708
Acronym / sponsor ID: LEAP / RD.06.SPR.204245
Conditions: Acne Vulgaris
Keywords: Acne vulgaris, Trifarotene, Aklief, CD5789
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 22 Dec 2021 (actual)
Primary completion: 15 Dec 2022 (actual)
Study completion: 15 Dec 2022 (actual)
First posted: 22 Oct 2021 (actual)
Results: Posted 20 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Trifarotene (CD5789) 50 mcg/g Cream	Experimental	Drug: Trifarotene Cream
Trifarotene Vehicle Cream	Placebo comparator	Drug: Trifarotene Vehicle Cream

Who may qualify

Ages: 13 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Participant with clinical diagnosis of acne vulgaris, defined by:
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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trifarotene CreamAlso: AkliefParticipants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks	Drug	Trifarotene (CD5789) 50 mcg/g Cream
Trifarotene Vehicle CreamParticipants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks	Drug	Trifarotene Vehicle Cream

Primary outcome

Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
Time frame: Baseline and 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.

3 secondary outcomes

Percent Change From Baseline in PIH ODS Scores at Week 24
Time frame: Baseline and Week 24
Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20
Time frame: 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
Time frame: Baseline, at Week 12, Week 16 and Week 20

Results and safety

Results posted to the registry on 20 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trifarotene (CD5789) Cream	60	45
Trifarotene Vehicle Cream	63	53

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

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: score on a scale

Measure	Trifarotene (CD5789) Cream n = 60	Trifarotene Vehicle Cream n = 63
Value	-2.1 (0.27)	-2.1 (0.24)

Population analysed: The Intent to Treat (ITT) population included all participants who were randomized.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from screening up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trifarotene (CD5789) Cream	0 of 60 (0%)	10 of 60 (16.7%)	0 of 60
Trifarotene Vehicle Cream	1 of 63 (1.6%)	19 of 63 (30.2%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41286546Dias-Barbosa C, Taylor N, Chan K, York JP, Puelles J, Chavda R. Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings. Patient. 2026 Mar;19(2):343-352. doi: 10.1007/s40271-025-00789-9. Epub 2025 Nov 24.

Related trials for Acne Vulgaris

RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
RecruitingPhase 1
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Acne

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trifarotene Cream in people with Acne Vulgaris, run by Galderma R&D at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05089708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.