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

• Status: Completed
• Trial end date: 2019-12-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Trifarotene

Criteria

Inclusion Criteria:

• The Subject is a male or female, 9 years of age or older, at Screening visit.

• The Subject has moderate acne at Screening and Baseline.

• The Subject is a female of non childbearing potential.

• The Subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees 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 Subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g., chloracne, drug induced acne, etc.).

• The Subject has 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 subject at significant risk (according to the Investigator's judgment) if the Subject takes part to the trial.

• The Subject has been exposed to excessive.

• The Subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).

• The Subject is unwilling to refrain from use of prohibited medication during the Clinical Trail.