Clinical trial NCT03915860: Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Official title: A Multi-Center Study to Evaluate Subject Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 47
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris

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.

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.

Primary outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24
timeFrame: Baseline, Week 12 and Week 24
measure: Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET)
timeFrame: Week 12 and Week 24/End of Treatment (ET)
measure: Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET)
timeFrame: Week 12 and Week 24/ET
measure: Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in EQ-5D-5L VAS at Week 12 and 24
timeFrame: Baseline, Week 12 and Week 24
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 12 and Week 24
measure: Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24
timeFrame: Week 12 and 24
measure: Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
timeFrame: Baseline, Week 12 and 24
measure: Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24
timeFrame: Baseline, Week 12 and Week 24
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Galderma Investigational Site
state: Arkansas
city: Beverly
country: United States
facility: Galderma Investigational Site
state: Massachusetts
city: Portsmouth
country: United States
facility: Galderma Investigational Site
state: New Hampshire
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Galderma Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Galderma Investigational Site
state: Texas
city: Irving
country: United States
facility: Galderma Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: Galderma Investigational Site
state: Texas
city: Richardson
country: United States
facility: Galderma Investigational Site
state: Texas
Study officials:
References: