Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris

Galderma R&D47 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

TrifaroteneDRUG

Topical Cream

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

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.

Locations (9)

Galderma Investigational Site

Fort Smith, Arkansas, United States

Galderma Investigational Site

Beverly, Massachusetts, United States

Galderma Investigational Site

Portsmouth, New Hampshire, United States

Galderma Investigational Site

Outcomes

Primary Outcomes

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score 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.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 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.

Time frame: Baseline, Week 12 and Week 24

Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 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.

Time frame: Baseline, Week 12 and Week 24

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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

Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at 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.

Time frame: Week 12 and 24

Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at 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.

Time frame: Baseline, Week 12 and 24

Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at 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.

Time frame: Baseline, Week 12 and Week 24