Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Study Details
Study Description
Brief Summary
Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
There was no formal hypothesis to be tested. Approximately 50 subjects would be enrolled to evaluate the subject reported outcomes (quality of life and satisfaction survey). The sample size was not based on any formal hypothesis testing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trifarotene Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
Drug: Trifarotene
Topical Cream
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 [Baseline, Week 12 and Week 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.
- Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24 [Baseline, Week 12 and Week 24]
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.
- Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24 [Baseline, Week 12 and Week 24]
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.
- Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET) [Week 12 and Week 24/End of Treatment (ET)]
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.
- Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET) [Week 12 and Week 24/ET]
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.
- Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24 [Baseline, Week 12 and Week 24]
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.
- Change From Baseline in EQ-5D-5L VAS at Week 12 and 24 [Baseline, Week 12 and Week 24]
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.
Secondary Outcome Measures
- 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 [Baseline, Week 12 and Week 24]
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.
- Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24 [Week 12 and 24]
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.
- Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 [Baseline, Week 12 and 24]
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.
- Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 [Baseline, Week 12 and Week 24]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The participant was a male or female, 9 years of age or older, at Screening visit.
-
The participant had moderate acne at Screening and Baseline.
-
The participant was a female of non childbearing potential.
-
The participant was a female of childbearing potential with a negative pregnancy test and who was strictly abstinent or who agreed to use an effective and approved contraceptive method for the duration of the study and at least 1 months after the last study drug application.
Exclusion Criteria:
-
The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g., chloracne, drug induced acne, etc.).
-
The participant had any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant took part to the trial.
-
The participant had been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the participant was planning intense UV exposure during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).
-
The participant was unwilling to refrain from use of prohibited medication during the Clinical Trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Galderma Investigational Site | Fort Smith | Arkansas | United States | 72916 |
| 2 | Galderma Investigational Site | Beverly | Massachusetts | United States | 01915 |
| 3 | Galderma Investigational Site | Portsmouth | New Hampshire | United States | 03801 |
| 4 | Galderma Investigational Site | Philadelphia | Pennsylvania | United States | 19103 |
| 5 | Galderma Investigational Site | Austin | Texas | United States | 78759 |
| 6 | Galderma Investigational Site | Beaumont | Texas | United States | 77701 |
| 7 | Galderma Investigational Site | Irving | Texas | United States | 75062 |
| 8 | Galderma Investigational Site | Pflugerville | Texas | United States | 78660 |
| 9 | Galderma Investigational Site | Richardson | Texas | United States | 75081 |
Sponsors and Collaborators
- Galderma R&D
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- RD.06.SPR.118295
Study Results
Participant Flow
| Recruitment Details | The study was conducted at United States between 27 March 2019 and 23 December 2019. |
|---|---|
| Pre-assignment Detail | A total of 47 participants were enrolled in the study. Of which, 46 participants were treated. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Period Title: Overall Study | |
| STARTED | 47 |
| Treated | 46 |
| COMPLETED | 33 |
| NOT COMPLETED | 14 |
Baseline Characteristics
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Overall Participants | 47 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
15.6
(3.00)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
13
27.7%
|
| Male |
34
72.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
10
21.3%
|
| Not Hispanic or Latino |
37
78.7%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
10.6%
|
| White |
42
89.4%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Dermatology Life Quality Index (DLQI) Score at Baseline (score on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [score on a scale] |
2.8
(3.00)
|
| C-DLQI (Children's Dermatology Life Quality Index) Score at Baseline (score on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [score on a scale] |
3.2
(4.17)
|
| Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne at Baseline (score on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [score on a scale] |
37.8
(17.69)
|
| EuroQoL 5-Dimension (EQ-5D-5L) Index Score at Baseline (score on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [score on a scale] |
0.9416
(0.07334)
|
| EuroQoL 5-Dimension (EQ-5D-5L) VAS Score at Baseline (score on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [score on a scale] |
90.0
(8.99)
|
Outcome Measures
| Title | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 10 |
| Week 12 |
-1.8
(2.97)
|
| Week 24 |
-0.5
(5.85)
|
| Title | Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 33 |
| Week 12 |
-1.7
(4.28)
|
| Week 24 |
-1.2
(5.03)
|
| Title | Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 19 |
| Week 12 |
-7.4
(17.39)
|
| Week 24 |
-0.6
(39.96)
|
| Title | Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET) |
|---|---|
| Description | 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. |
| Time Frame | Week 12 and Week 24/End of Treatment (ET) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Week 12: Bothered By Treatment Side Effects: Not bothered at all |
18
38.3%
|
| Week 12: Bothered By Treatment Side Effects: Bothered somewhat |
15
31.9%
|
| Week 12: Bothered By Treatment Side Effects: Bothered |
0
0%
|
| Week 12: Bothered By Treatment Side Effects: Bothered a great deal |
1
2.1%
|
| Week 12: Satisfied with the time it took for treatment to work: Very satisfied |
8
17%
|
| Week 12: Satisfied with the time it took for treatment to work: satisfied |
14
29.8%
|
| Week 12: Satisfied with the time it took for treatment to work: Somewhat satisfied |
9
19.1%
|
| Week 12: Satisfied with the time it took for treatment to work: Not satisfied |
3
6.4%
|
| Week 12: Satisfied with effectiveness of treatment: Very satisfied |
5
10.6%
|
| Week 12: Satisfied with effectiveness of treatment: satisfied |
18
38.3%
|
| Week 12: Satisfied with effectiveness of treatment: Somewhat satisfied |
8
17%
|
| Week 12: Satisfied with effectiveness of treatment: Not satisfied |
3
6.4%
|
| Week 12: Feel about yourself: Very much better |
5
10.6%
|
| Week 12: Feel about yourself: A lot better |
14
29.8%
|
| Week 12: Feel about yourself: A little better |
13
27.7%
|
| Week 12: Feel about yourself: Worse |
2
4.3%
|
| Week 12: Overall-satisfied with the treatment: Very satisfied |
6
12.8%
|
| Week 12: Overall-satisfied with the treatment: satisfied |
18
38.3%
|
| Week 12: Overall-satisfied with the treatment: Somewhat satisfied |
7
14.9%
|
| Week 12: Overall-satisfied with the treatment: Not satisfied |
3
6.4%
|
| Week 12: Would you consider using this treatment again -Yes |
31
66%
|
| Week 12: Would you consider using this treatment again - No |
3
6.4%
|
| Week 12: Used moisturizing lotion: Yes |
32
68.1%
|
| Week 12: Used moisturizing lotion: No |
2
4.3%
|
| Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes |
23
48.9%
|
| Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: No |
9
19.1%
|
| Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes |
7
14.9%
|
| Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No |
25
53.2%
|
| Week 12: Used moisturizing lotion: moisturizer was pleasant to use: Yes |
15
31.9%
|
| Week 12: Used moisturizing lotion: moisturizer was pleasant to use: No |
17
36.2%
|
| Week 12: Used moisturizing lotion: None of the above: Yes |
2
4.3%
|
| Week 12: Used moisturizing lotion: None of the above: No |
30
63.8%
|
| Week 24/ET: Bothered By Treatment Side Effects: Not bothered at all |
22
46.8%
|
| Week 24/ET: Bothered By Treatment Side Effects: Bothered somewhat |
13
27.7%
|
| Week 24/ET: Bothered By Treatment Side Effects: Bothered |
4
8.5%
|
| Week 24/ET: Bothered By Treatment Side Effects: Bothered a great deal |
0
0%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: Very satisfied |
9
19.1%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: satisfied |
20
42.6%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: Somewhat satisfied |
5
10.6%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: Not satisfied |
5
10.6%
|
| Week 24/ET: Satisfied with effectiveness of treatment: Very satisfied |
11
23.4%
|
| Week 24/ET: Satisfied with effectiveness of treatment: satisfied |
15
31.9%
|
| Week 24/ET: Satisfied with effectiveness of treatment: Somewhat satisfied |
8
17%
|
| Week 24/ET: Satisfied with effectiveness of treatment: Not satisfied |
5
10.6%
|
| Week 24/ET: Feel about yourself: Very much better |
9
19.1%
|
| Week 24/ET: Feel about yourself: A lot better |
9
19.1%
|
| Week 24/ET: Feel about yourself: A little better |
19
40.4%
|
| Week 24/ET: Feel about yourself: Worse |
2
4.3%
|
| Week 24/ET: Overall-satisfied with the treatment: Very satisfied |
12
25.5%
|
| Week 24/ET: Overall-satisfied with the treatment: satisfied |
12
25.5%
|
| Week 24/ET: Overall-satisfied with the treatment: Somewhat satisfied |
11
23.4%
|
| Week 24/ET: Overall-satisfied with the treatment: Not satisfied |
4
8.5%
|
| Week 24/ET: Would you consider using this treatment again -Yes |
28
59.6%
|
| Week 24/ET: Would you consider using this treatment again - No |
11
23.4%
|
| Week 24/ET: Used moisturizing lotion: Yes |
38
80.9%
|
| Week 24/ET: Used moisturizing lotion: No |
1
2.1%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes |
30
63.8%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: No |
8
17%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes |
7
14.9%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No |
31
66%
|
| Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: Yes |
15
31.9%
|
| Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: No |
23
48.9%
|
| Week 24/ET: Used moisturizing lotion: None of the above: Yes |
2
4.3%
|
| Week 24/ET: Used moisturizing lotion: None of the above: No |
36
76.6%
|
| Title | Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET) |
|---|---|
| Description | 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. |
| Time Frame | Week 12 and Week 24/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Week 12: Bothered By Treatment Side Effects: Not bothered at all |
23
48.9%
|
| Week 12: Bothered By Treatment Side Effects: Bothered somewhat |
9
19.1%
|
| Week 12: Bothered By Treatment Side Effects: Bothered |
2
4.3%
|
| Week 12: Bothered By Treatment Side Effects: Bothered a great deal |
0
0%
|
| Week 12: Satisfied with the time it took for treatment to work: Very satisfied |
8
17%
|
| Week 12: Satisfied with the time it took for treatment to work: satisfied |
16
34%
|
| Week 12: Satisfied with the time it took for treatment to work: Somewhat satisfied |
8
17%
|
| Week 12: Satisfied with the time it took for treatment to work: Not satisfied |
2
4.3%
|
| Week 12: Satisfied with effectiveness of treatment: Very satisfied |
5
10.6%
|
| Week 12: Satisfied with effectiveness of treatment: satisfied |
18
38.3%
|
| Week 12: Satisfied with effectiveness of treatment: Somewhat satisfied |
10
21.3%
|
| Week 12: Satisfied with effectiveness of treatment: Not satisfied |
1
2.1%
|
| Week 12: Feel about yourself: Very much better |
6
12.8%
|
| Week 12: Feel about yourself: A lot better |
14
29.8%
|
| Week 12: Feel about yourself: A little better |
14
29.8%
|
| Week 12: Feel about yourself: Worse |
0
0%
|
| Week 12: Overall-satisfied with the treatment: Very satisfied |
8
17%
|
| Week 12: Overall-satisfied with the treatment: satisfied |
13
27.7%
|
| Week 12: Overall-satisfied with the treatment: Somewhat satisfied |
10
21.3%
|
| Week 12: Overall-satisfied with the treatment: Not satisfied |
3
6.4%
|
| Week 12: Would you consider using this treatment again -Yes |
32
68.1%
|
| Week 12: Would you consider using this treatment again - No |
2
4.3%
|
| Week 12: Used moisturizing lotion: Yes |
33
70.2%
|
| Week 12: Used moisturizing lotion: No |
1
2.1%
|
| Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes |
23
48.9%
|
| Week 12: Used moisturizing lotion: moisturizer helps to reduce irritation: No |
10
21.3%
|
| Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes |
8
17%
|
| Week 12: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No |
25
53.2%
|
| Week 12: Used moisturizing lotion: moisturizer was pleasant to use: Yes |
14
29.8%
|
| Week 12: Used moisturizing lotion: moisturizer was pleasant to use: No |
19
40.4%
|
| Week 12: Used moisturizing lotion: None of the above: Yes |
3
6.4%
|
| Week 12: Used moisturizing lotion: None of the above: No |
30
63.8%
|
| Week 24/ET: Bothered By Treatment Side Effects: Not bothered at all |
22
46.8%
|
| Week 24/ET: Bothered By Treatment Side Effects: Bothered somewhat |
13
27.7%
|
| Week 24/ET: Bothered By Treatment Side Effects: Bothered |
4
8.5%
|
| Week 24/ET: Bothered By Treatment Side Effects: Bothered a great deal |
0
0%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: Very satisfied |
7
14.9%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: satisfied |
22
46.8%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: Somewhat satisfied |
5
10.6%
|
| Week 24/ET: Satisfied with the time it took for treatment to work: Not satisfied |
5
10.6%
|
| Week 24/ET: Satisfied with effectiveness of treatment: Very satisfied |
8
17%
|
| Week 24/ET: Satisfied with effectiveness of treatment: satisfied |
19
40.4%
|
| Week 24/ET: Satisfied with effectiveness of treatment: Somewhat satisfied |
7
14.9%
|
| Week 24/ET: Satisfied with effectiveness of treatment: Not satisfied |
5
10.6%
|
| Week 24/ET: Feel about yourself: Very much better |
8
17%
|
| Week 24/ET: Feel about yourself: A lot better |
11
23.4%
|
| Week 24/ET: Feel about yourself: A little better |
19
40.4%
|
| Week 24/ET: Feel about yourself: Worse |
1
2.1%
|
| Week 24/ET: Overall-satisfied with the treatment: Very satisfied |
10
21.3%
|
| Week 24/ET: Overall-satisfied with the treatment: satisfied |
17
36.2%
|
| Week 24/ET: Overall-satisfied with the treatment: Somewhat satisfied |
9
19.1%
|
| Week 24/ET: Overall-satisfied with the treatment: Not satisfied |
3
6.4%
|
| Week 24/ET: Would you consider using this treatment again -Yes |
28
59.6%
|
| Week 24/ET: Would you consider using this treatment again - No |
11
23.4%
|
| Week 24/ET: Used moisturizing lotion: Yes |
37
78.7%
|
| Week 24/ET: Used moisturizing lotion: No |
2
4.3%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: Yes |
30
63.8%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps to reduce irritation: No |
7
14.9%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: Yes |
8
17%
|
| Week 24/ET: Used moisturizing lotion: moisturizer helps you to be adherent to study treatment: No |
29
61.7%
|
| Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: Yes |
13
27.7%
|
| Week 24/ET: Used moisturizing lotion: moisturizer was pleasant to use: No |
24
51.1%
|
| Week 24/ET: Used moisturizing lotion: None of the above: Yes |
2
4.3%
|
| Week 24/ET: Used moisturizing lotion: None of the above: No |
35
74.5%
|
| Title | Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT population. Here, number analyzed=participants with available data at specified time-points. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Week 12 |
-0.0140
(0.09626)
|
| Week 24 |
0.0135
(0.08394)
|
| Title | Change From Baseline in EQ-5D-5L VAS at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT population. Here, number analyzed=participants with available data at specified time-points. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Week 12 |
1.0
(8.96)
|
| Week 24 |
3.7
(7.96)
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Intent-to-treat (ITT) population that included all enrolled participants. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Week 12 |
6.4
13.6%
|
| Week 24 |
19.1
40.6%
|
| Title | Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Week 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Week 12 |
14.9
31.7%
|
| Week 24 |
6.4
13.6%
|
| Title | Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT population. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Inflammatory Lesion: Week 12 |
-35.81
(41.124)
|
| Inflammatory Lesion: Week 24 |
-38.59
(42.643)
|
| Non-Inflammatory Lesion: Week 12 |
-23.17
(45.506)
|
| Non-Inflammatory Lesion: Week 24 |
-35.16
(46.946)
|
| Title | Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 12 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT population. |
| Arm/Group Title | Trifarotene |
|---|---|
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Measure Participants | 47 |
| Inflammatory Lesion: Week 12 |
-39.97
(32.564)
|
| Inflammatory Lesion: Week 24 |
-41.36
(39.131)
|
| Non-Inflammatory Lesion: Week 12 |
-35.24
(39.337)
|
| Non-Inflammatory Lesion: Week 24 |
-44.20
(37.650)
|
Adverse Events
| Time Frame | From start of the study drug administration up to end of the study (Week 24). | |
|---|---|---|
| Adverse Event Reporting Description | Analysis was performed on Safety Population that included any enrolled participants who applied/were administered the study drug at least once. | |
| Arm/Group Title | Trifarotene | |
| Arm/Group Description | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. | |
All Cause Mortality |
||
| Trifarotene | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | |
Serious Adverse Events |
||
| Trifarotene | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Trifarotene | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/46 (19.6%) | |
| General disorders | ||
| Application site pain | 5/46 (10.9%) | 10 |
| Application site dermatitis | 3/46 (6.5%) | 3 |
| Injury, poisoning and procedural complications | ||
| Sunburn | 3/46 (6.5%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Operations |
|---|---|
| Organization | Galderma |
| Phone | 817 961 5000 ext 1 |
| Clinical.Studies@galderma.com |
- RD.06.SPR.118295