Trial Outcomes & Findings for Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris (NCT NCT03915860)
NCT ID: NCT03915860
Last Updated: 2021-12-15
Results Overview
The DLQI was validated 10-item questionnaire for participants aged \>16 years that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). The total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
47 participants
Primary outcome timeframe
Baseline, Week 12 and Week 24
Results posted on
2021-12-15
Participant Flow
The study was conducted at United States between 27 March 2019 and 23 December 2019.
A total of 47 participants were enrolled in the study. Of which, 46 participants were treated.
Participant milestones
| Measure |
Trifarotene
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
Treated
|
46
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Trifarotene
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other than specified
|
3
|
Baseline Characteristics
Here, number analyzed=participants with available data at Baseline.
Baseline characteristics by cohort
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 3.00 • n=47 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
|
Dermatology Life Quality Index (DLQI) Score at Baseline
|
2.8 score on a scale
STANDARD_DEVIATION 3.00 • n=13 Participants • Here, number analyzed=participants with available data at Baseline.
|
|
C-DLQI (Children's Dermatology Life Quality Index) Score at Baseline
|
3.2 score on a scale
STANDARD_DEVIATION 4.17 • n=33 Participants • Here, number analyzed=participants with available data at Baseline.
|
|
Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne at Baseline
|
37.8 score on a scale
STANDARD_DEVIATION 17.69 • n=19 Participants • Here, number analyzed=participants with available data at Baseline
|
|
EuroQoL 5-Dimension (EQ-5D-5L) Index Score at Baseline
|
0.9416 score on a scale
STANDARD_DEVIATION 0.07334 • n=47 Participants
|
|
EuroQoL 5-Dimension (EQ-5D-5L) VAS Score at Baseline
|
90.0 score on a scale
STANDARD_DEVIATION 8.99 • n=47 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population that included all enrolled participants. Here, overall number of participants analyzed=participants with available data at Week 12 and 24.
The DLQI was validated 10-item questionnaire for participants aged \>16 years that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). The total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Outcome measures
| Measure |
Trifarotene
n=10 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24
Week 12
|
-1.8 score on a scale
Standard Deviation 2.97
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24
Week 24
|
-0.5 score on a scale
Standard Deviation 5.85
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data at Baseline. Number analyzed=participants with available data at specified time-points.
The C-DLQI are validated 10-item questionnaire for participants aged \<=16 that measured the dermatology related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Questions were scored as follows: No effect (0-1), Small effect (2-6), Moderate effect (7-12), Very large effect (13-18), Extremely large effect (19-30). The total C-DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 (Extremely large effect) and a minimum of 0 (No effect). A lower score on the C-DLQI indicates increased QOL.
Outcome measures
| Measure |
Trifarotene
n=33 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24
Week 12
|
-1.7 score on a scale
Standard Deviation 4.28
|
|
Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24
Week 24
|
-1.2 score on a scale
Standard Deviation 5.03
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data at Baseline. Number analyzed=participants with available data at specified time-points.
The CompAQ questionnaire is a comprehensive measure of facial and truncal acne's impact on health-related QOL. The 20 questions consisted of 5 domains that assessed a variety of psychosocial and physical impacts of acne: Psychological/Emotional, Social (Judgement from Others), Social Interactions, Treatment Concerns, Physical Symptoms. Each question is assessed with a numeric score between 0 (Never) and 8 (All the time) with a total possible score range of 0 (No effect) -160 (greater adverse impact). The higher the score, the more quality of life is impaired.
Outcome measures
| Measure |
Trifarotene
n=19 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24
Week 12
|
-7.4 score on a scale
Standard Deviation 17.39
|
|
Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24
Week 24
|
-0.6 score on a scale
Standard Deviation 39.96
|
PRIMARY outcome
Timeframe: Week 12 and Week 24/End of Treatment (ET)Population: Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points.
Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Feel about yourself: A lot better
|
9 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Feel about yourself: A little better
|
19 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Feel about yourself: Worse
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: Very satisfied
|
12 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: satisfied
|
12 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: Somewhat satisfied
|
11 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: Not satisfied
|
4 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Would you consider using this treatment again -Yes
|
28 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Would you consider using this treatment again - No
|
11 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: Yes
|
38 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: No
|
1 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes
|
30 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: No
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes
|
7 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No
|
31 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: Yes
|
15 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: No
|
23 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: None of the above: Yes
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: None of the above: No
|
36 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Not bothered at all
|
18 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Bothered somewhat
|
15 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Bothered
|
0 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Bothered a great deal
|
1 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: Very satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: satisfied
|
14 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: Somewhat satisfied
|
9 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: Not satisfied
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: Very satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: satisfied
|
18 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: Somewhat satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: Not satisfied
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Feel about yourself: Very much better
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Feel about yourself: A lot better
|
14 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Feel about yourself: A little better
|
13 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Feel about yourself: Worse
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: Very satisfied
|
6 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: satisfied
|
18 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: Somewhat satisfied
|
7 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: Not satisfied
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Would you consider using this treatment again -Yes
|
31 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Would you consider using this treatment again - No
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: Yes
|
32 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: No
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes
|
23 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: No
|
9 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes
|
7 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No
|
25 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer was pleasant to use: Yes
|
15 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer was pleasant to use: No
|
17 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: None of the above: Yes
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 12: Used moisturizing lotion: None of the above: No
|
30 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Not bothered at all
|
22 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Bothered somewhat
|
13 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Bothered
|
4 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Bothered a great deal
|
0 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: Very satisfied
|
9 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: satisfied
|
20 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: Somewhat satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: Not satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: Very satisfied
|
11 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: satisfied
|
15 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: Somewhat satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: Not satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
Week 24/ET: Feel about yourself: Very much better
|
9 Participants
|
PRIMARY outcome
Timeframe: Week 12 and Week 24/ETPopulation: Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points.
Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: Very satisfied
|
7 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: satisfied
|
22 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Not bothered at all
|
23 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Bothered somewhat
|
9 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Bothered
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Bothered By Treatment Side Effects: Bothered a great deal
|
0 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: Very satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: satisfied
|
16 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: Somewhat satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with the time it took for treatment to work: Not satisfied
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: Very satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: satisfied
|
18 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: Somewhat satisfied
|
10 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Satisfied with effectiveness of treatment: Not satisfied
|
1 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Feel about yourself: Very much better
|
6 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Feel about yourself: A lot better
|
14 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Feel about yourself: A little better
|
14 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Feel about yourself: Worse
|
0 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: Very satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: satisfied
|
13 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: Somewhat satisfied
|
10 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Overall-satisfied with the treatment: Not satisfied
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Would you consider using this treatment again -Yes
|
32 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Would you consider using this treatment again - No
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: Yes
|
33 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: No
|
1 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes
|
23 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: No
|
10 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No
|
25 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer was pleasant to use: Yes
|
14 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: moisturizer was pleasant to use: No
|
19 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: None of the above: Yes
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 12: Used moisturizing lotion: None of the above: No
|
30 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Not bothered at all
|
22 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Bothered somewhat
|
13 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Bothered
|
4 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Bothered By Treatment Side Effects: Bothered a great deal
|
0 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: Somewhat satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with the time it took for treatment to work: Not satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: Very satisfied
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: satisfied
|
19 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: Somewhat satisfied
|
7 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Satisfied with effectiveness of treatment: Not satisfied
|
5 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Feel about yourself: Very much better
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: No
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Feel about yourself: A lot better
|
11 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Feel about yourself: A little better
|
19 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Feel about yourself: Worse
|
1 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: Very satisfied
|
10 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: satisfied
|
17 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: Somewhat satisfied
|
9 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Overall-satisfied with the treatment: Not satisfied
|
3 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Would you consider using this treatment again -Yes
|
28 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Would you consider using this treatment again - No
|
11 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: Yes
|
37 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes
|
30 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: No
|
7 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes
|
8 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No
|
29 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: Yes
|
13 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: No
|
24 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: None of the above: Yes
|
2 Participants
|
|
Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
Week 24/ET: Used moisturizing lotion: None of the above: No
|
35 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, number analyzed=participants with available data at specified time-points.
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United States (US) algorithm, with scores ranging from -0.109 (extreme problems) to 1 (no problems). A higher score indicates better health state.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24
Week 12
|
-0.0140 score on a scale
Standard Deviation 0.09626
|
|
Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24
Week 24
|
0.0135 score on a scale
Standard Deviation 0.08394
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population. Here, number analyzed=participants with available data at specified time-points.
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Change From Baseline in EQ-5D-5L VAS at Week 12 and 24
Week 12
|
1.0 score on a scale
Standard Deviation 8.96
|
|
Change From Baseline in EQ-5D-5L VAS at Week 12 and 24
Week 24
|
3.7 score on a scale
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on Intent-to-treat (ITT) population that included all enrolled participants.
IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12 and Week 24
Week 12
|
6.4 percentage of participants
Interval 1.3 to 17.5
|
|
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12 and Week 24
Week 24
|
19.1 percentage of participants
Interval 9.1 to 33.3
|
SECONDARY outcome
Timeframe: Week 12 and 24Population: Analysis was performed on Intent-to-treat on the Trunk (ITTT) population that included any participants who were enrolled with moderate truncal acne at the Baseline visit.
The Physician's Global Assessment (PGA) was an instrument to evaluate the truncal acne severity in the shoulders, upper back and upper anterior chest areas. PGA was recorded from components collected on the CRF using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24
Week 12
|
14.9 percentage of participants
Interval 6.2 to 28.3
|
|
Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24
Week 24
|
6.4 percentage of participants
Interval 1.3 to 17.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 24Population: Analysis was performed on ITT population.
Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Inflammatory Lesion: Week 12
|
-35.81 percent change
Standard Deviation 41.124
|
|
Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Inflammatory Lesion: Week 24
|
-38.59 percent change
Standard Deviation 42.643
|
|
Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Non-Inflammatory Lesion: Week 12
|
-23.17 percent change
Standard Deviation 45.506
|
|
Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Non-Inflammatory Lesion: Week 24
|
-35.16 percent change
Standard Deviation 46.946
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Analysis was performed on ITT population.
Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Trifarotene
n=47 Participants
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Non-Inflammatory Lesion: Week 24
|
-44.20 percent change
Standard Deviation 37.650
|
|
Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Inflammatory Lesion: Week 12
|
-39.97 percent change
Standard Deviation 32.564
|
|
Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Inflammatory Lesion: Week 24
|
-41.36 percent change
Standard Deviation 39.131
|
|
Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
Non-Inflammatory Lesion: Week 12
|
-35.24 percent change
Standard Deviation 39.337
|
Adverse Events
Trifarotene
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trifarotene
n=46 participants at risk
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
|
|---|---|
|
General disorders
Application site pain
|
10.9%
5/46 • Number of events 10 • From start of the study drug administration up to end of the study (Week 24).
Analysis was performed on Safety Population that included any enrolled participants who applied/were administered the study drug at least once.
|
|
General disorders
Application site dermatitis
|
6.5%
3/46 • Number of events 3 • From start of the study drug administration up to end of the study (Week 24).
Analysis was performed on Safety Population that included any enrolled participants who applied/were administered the study drug at least once.
|
|
Injury, poisoning and procedural complications
Sunburn
|
6.5%
3/46 • Number of events 3 • From start of the study drug administration up to end of the study (Week 24).
Analysis was performed on Safety Population that included any enrolled participants who applied/were administered the study drug at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER