Trial Outcomes & Findings for AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (NCT NCT05089708)

Last Updated: 2023-12-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

123 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2023-12-20

Participant Flow

The study was conducted at 18 investigational centers in the United States and Spain from 22 Dec 2021 to 15 Dec 2022.

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.

Participant milestones

Participant milestones
Measure	Trifarotene (CD5789) Cream Participants applied Trifarotene 50 micrograms per gram (mcg/g) cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
Overall Study STARTED	60	63
Overall Study COMPLETED	45	53
Overall Study NOT COMPLETED	15	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Trifarotene (CD5789) Cream Participants applied Trifarotene 50 micrograms per gram (mcg/g) cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
Overall Study Lost to Follow-up	9	7
Overall Study Withdrawal by Subject	3	1
Overall Study Non-Compliance with Investigational Product	1	1
Overall Study Withdrawal by Parent or Guardian	2	1

Baseline Characteristics

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trifarotene (CD5789) Cream n=60 Participants Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 Participants Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.	Total n=123 Participants Total of all reporting groups
Age, Continuous	22.7 years STANDARD_DEVIATION 6.30 • n=93 Participants	21.9 years STANDARD_DEVIATION 5.95 • n=4 Participants	22.3 years STANDARD_DEVIATION 6.11 • n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	48 Participants n=4 Participants	93 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=93 Participants	27 Participants n=4 Participants	48 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=93 Participants	36 Participants n=4 Participants	75 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	11 Participants n=93 Participants	6 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Black or African American	22 Participants n=93 Participants	23 Participants n=4 Participants	45 Participants n=27 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants	31 Participants n=4 Participants	56 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

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

Outcome measures

Outcome measures
Measure	Trifarotene (CD5789) Cream n=60 Participants Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 Participants Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
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	-2.1 score on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The ITT population included all participants who were randomized.

Outcome measures

Outcome measures
Measure	Trifarotene (CD5789) Cream n=60 Participants Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 Participants Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
Percent Change From Baseline in PIH ODS Scores at Week 24	-45.4 Percent change Standard Error 5.73	-44.9 Percent change Standard Error 5.18

SECONDARY outcome

Timeframe: Baseline, at Week 12, Week 16 and Week 20

Population: The ITT population included all participants who were randomized.

Outcome measures

Outcome measures
Measure	Trifarotene (CD5789) Cream n=60 Participants Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 Participants Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
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	-1.1 score on a scale Standard Error 0.17
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	-1.7 score on a scale Standard Error 0.19
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	-1.9 score on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, at Week 12, Week 16 and Week 20

Population: The ITT population included all participants who were randomized.

Outcome measures

Outcome measures
Measure	Trifarotene (CD5789) Cream n=60 Participants Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 Participants Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
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	-23.6 Percent change Standard Error 3.60
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	-36.1 Percent change Standard Error 4.17
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	-41.0 Percent change Standard Error 4.75

Adverse Events

Trifarotene (CD5789) Cream

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Trifarotene Vehicle Cream

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trifarotene (CD5789) Cream n=60 participants at risk Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 participants at risk Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
Psychiatric disorders Bipolar Disorder	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24

Other adverse events

Additional Information

Clinical Scientist

Galderma

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Trifarotene (CD5789) Cream n=60 participants at risk Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks.	Trifarotene Vehicle Cream n=63 participants at risk Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
Infections and infestations COVID-19	5.0% 3/60 • Number of events 3 • Adverse events were assessed from screening up to Week 24	9.5% 6/63 • Number of events 6 • Adverse events were assessed from screening up to Week 24
Infections and infestations Influenza	3.3% 2/60 • Number of events 2 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Nasopharyngitis	3.3% 2/60 • Number of events 2 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Bacterial vaginosis	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Ear infection	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Respiratory syncytial virus infection	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Tonsillitis	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Upper respiratory tract infection	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Infections and infestations Vaginal infection	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Gastrointestinal disorders Toothache	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Gastrointestinal disorders Vomiting	1.7% 1/60 • Number of events 1 • Adverse events were assessed from screening up to Week 24	0.00% 0/63 • Adverse events were assessed from screening up to Week 24
Nervous system disorders Headached	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	3.2% 2/63 • Number of events 2 • Adverse events were assessed from screening up to Week 24
Psychiatric disorders Attention deficit hyperactivity disorder	1.7% 1/60 • Number of events 1 • Adverse events were assessed from screening up to Week 24	0.00% 0/63 • Adverse events were assessed from screening up to Week 24
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	3.2% 2/63 • Number of events 2 • Adverse events were assessed from screening up to Week 24
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.7% 1/60 • Number of events 1 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Eye disorders Eye irritation	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
General disorders Application site burn	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Musculoskeletal and connective tissue disorders Muscle spasms	1.7% 1/60 • Number of events 1 • Adverse events were assessed from screening up to Week 24	0.00% 0/63 • Adverse events were assessed from screening up to Week 24
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair follicle tumour benign	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24
Psychiatric disorders Bipolar I disorder	0.00% 0/60 • Adverse events were assessed from screening up to Week 24	1.6% 1/63 • Number of events 1 • Adverse events were assessed from screening up to Week 24