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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915860
• Other study ID #: RD.06.SPR.118295
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: April 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Trifarotene
Topical Cream

Locations

Country	Name	City	State
United States	Galderma Investigational Site	Austin	Texas
United States	Galderma Investigational Site	Beaumont	Texas
United States	Galderma Investigational Site	Beverly	Massachusetts
United States	Galderma Investigational Site	Fort Smith	Arkansas
United States	Galderma Investigational Site	Irving	Texas
United States	Galderma Investigational Site	Pflugerville	Texas
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Portsmouth	New Hampshire
United States	Galderma Investigational Site	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12 and Week 24
Primary	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.	Baseline, Week 12 and Week 24
Primary	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.	Baseline, Week 12 and Week 24
Primary	Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 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.	Week 12 and Week 24/End of Treatment (ET)
Primary	Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 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.	Week 12 and Week 24/ET
Primary	Change From Baseline in EQ-5D-5L Index Score at Week 12 and 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.	Baseline, Week 12 and Week 24
Primary	Change From Baseline in EQ-5D-5L VAS at Week 12 and 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.	Baseline, Week 12 and Week 24
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	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.	Baseline, Week 12 and Week 24
Secondary	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.	Week 12 and 24
Secondary	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.	Baseline, Week 12 and 24
Secondary	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.	Baseline, Week 12 and Week 24