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

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Trifarotene

Study type: Interventional

Funder types: Industry

Identifiers

NCT03915860

RD.06.SPR.118295

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Trifarotene

Experimental group

Description:

Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.

Treatment:

Drug: Trifarotene