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

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ClinicalTrials.gov Identifier: NCT03915860
Recruitment Status : Completed
First Posted : April 16, 2019
Results First Posted : December 15, 2021
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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
Acne Vulgaris Drug: Trifarotene 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Trifarotene

Arm Intervention/treatment
Experimental: Trifarotene
Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
Drug: Trifarotene
Topical Cream




Primary Outcome Measures :
  1. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 [ Time Frame: 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.

  2. Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24 [ Time Frame: 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.

  3. Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24 [ Time Frame: 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.

  4. Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET) [ Time Frame: 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.

  5. Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET) [ Time Frame: 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.

  6. Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24 [ Time Frame: 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.

  7. Change From Baseline in EQ-5D-5L VAS at Week 12 and 24 [ Time Frame: 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 :
  1. 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 ]
    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.

  2. Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24 [ Time Frame: 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.

  3. Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 [ Time Frame: 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.

  4. Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915860


Locations
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United States, Arkansas
Galderma Investigational Site
Fort Smith, Arkansas, United States, 72916
United States, Massachusetts
Galderma Investigational Site
Beverly, Massachusetts, United States, 01915
United States, New Hampshire
Galderma Investigational Site
Portsmouth, New Hampshire, United States, 03801
United States, Pennsylvania
Galderma Investigational Site
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
Galderma Investigational Site
Austin, Texas, United States, 78759
Galderma Investigational Site
Beaumont, Texas, United States, 77701
Galderma Investigational Site
Irving, Texas, United States, 75062
Galderma Investigational Site
Pflugerville, Texas, United States, 78660
Galderma Investigational Site
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Galderma R&D
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Study Protocol  [PDF] June 4, 2019
Statistical Analysis Plan  [PDF] June 4, 2019

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03915860    
Other Study ID Numbers: RD.06.SPR.118295
First Posted: April 16, 2019    Key Record Dates
Results First Posted: December 15, 2021
Last Update Posted: December 15, 2021
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Trifarotene
Dermatologic Agents