Phase 3
N=47
Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT03915860 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 — -1.8; -0.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trifarotene (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 |
-1.8; -0.5 | — |
| PRIMARY Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24 |
-1.7; -1.2 | — |
| PRIMARY Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24 |
-7.4; -0.6 | — |
| PRIMARY Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET) |
18; 15; 0; 1; 8; 14 | — |
| PRIMARY Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET) |
23; 9; 2; 0; 8; 16 | — |
| PRIMARY Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24 |
-0.0140; 0.0135 | — |
| PRIMARY Change From Baseline in EQ-5D-5L VAS at Week 12 and 24 |
1.0; 3.7 | — |
| SECONDARY 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 |
6.4; 19.1 | — |
| SECONDARY Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24 |
14.9; 6.4 | — |
| SECONDARY Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 |
-35.81; -38.59; -23.17; -35.16 | — |
| SECONDARY Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 |
-39.97; -41.36; -35.24; -44.20 | — |
Summary
Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03915860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.