Acne Vulgaris
Conditions
Keywords
Acne vulgaris, Trifarotene, Aklief, CD5789
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
Interventions
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
Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in PIH ODS Scores at Week 24 | 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. |
| Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Baseline, at Week 12, Week 16 and Week 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. |
| 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 | 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. |
Countries
Spain, United States
Participant flow
Recruitment details
The study was conducted at 18 investigational centers in the United States and Spain from 22 Dec 2021 to 15 Dec 2022.
Pre-assignment details
A total of 150 participants were screened, out of which 123 participants were randomized and enrolled in two treatment groups. 60 participants were randomized in Trifarotene (CD5789) Cream treatment group and 63 were assigned in Trifarotene Vehicle Cream treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Trifarotene (CD5789) Cream Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks. | 60 |
| Trifarotene Vehicle Cream Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks. | 63 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Non-Compliance with Investigational Product | 1 | 1 |
| Overall Study | Withdrawal by Parent or Guardian | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Trifarotene Vehicle Cream | Total | Trifarotene (CD5789) Cream |
|---|---|---|---|
| Age, Continuous | 21.9 years STANDARD_DEVIATION 5.95 | 22.3 years STANDARD_DEVIATION 6.11 | 22.7 years STANDARD_DEVIATION 6.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 48 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 75 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 45 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 31 Participants | 56 Participants | 25 Participants |
| Sex: Female, Male Female | 48 Participants | 93 Participants | 45 Participants |
| Sex: Female, Male Male | 15 Participants | 30 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 63 |
| other Total, other adverse events | 10 / 60 | 19 / 63 |
| serious Total, serious adverse events | 0 / 60 | 1 / 63 |
Outcome results
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 \<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.
Time frame: Baseline and Week 24
Population: The Intent to Treat (ITT) population included all participants who were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Trifarotene (CD5789) Cream | Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 | -2.1 score on a scale | Standard Error 0.27 |
| Trifarotene Vehicle Cream | Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 | -2.1 score on a scale | Standard Error 0.24 |
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 \<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.
Time frame: Baseline, at Week 12, Week 16 and Week 20
Population: The ITT population included all participants who were randomized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Trifarotene (CD5789) Cream | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Absolute change at Week 12 | -1.6 score on a scale | Standard Error 0.18 |
| Trifarotene (CD5789) Cream | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Absolute change at Week 16 | -1.9 score on a scale | Standard Error 0.2 |
| Trifarotene (CD5789) Cream | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Absolute change at Week 20 | -2.0 score on a scale | Standard Error 0.22 |
| Trifarotene Vehicle Cream | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Absolute change at Week 12 | -1.1 score on a scale | Standard Error 0.17 |
| Trifarotene Vehicle Cream | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Absolute change at Week 16 | -1.7 score on a scale | Standard Error 0.19 |
| Trifarotene Vehicle Cream | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | Absolute change at Week 20 | -1.9 score on a scale | Standard Error 0.21 |
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 \<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.
Time frame: Baseline and Week 24
Population: The ITT population included all participants who were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Trifarotene (CD5789) Cream | Percent Change From Baseline in PIH ODS Scores at Week 24 | -45.4 Percent change | Standard Error 5.73 |
| Trifarotene Vehicle Cream | Percent Change From Baseline in PIH ODS Scores at Week 24 | -44.9 Percent change | Standard Error 5.18 |
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 \<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.
Time frame: Baseline, at Week 12, Week 16 and Week 20
Population: The ITT population included all participants who were randomized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Trifarotene (CD5789) Cream | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | Percent Change at Week 12 | -34.4 Percent change | Standard Error 3.78 |
| Trifarotene (CD5789) Cream | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | Percent Change at Week 16 | -41.2 Percent change | Standard Error 4.35 |
| Trifarotene (CD5789) Cream | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | Percent Change at Week 20 | -43.9 Percent change | Standard Error 4.83 |
| Trifarotene Vehicle Cream | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | Percent Change at Week 12 | -23.6 Percent change | Standard Error 3.6 |
| Trifarotene Vehicle Cream | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | Percent Change at Week 16 | -36.1 Percent change | Standard Error 4.17 |
| Trifarotene Vehicle Cream | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | Percent Change at Week 20 | -41.0 Percent change | Standard Error 4.75 |