Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Placebo cream; Drug: CD5789 (trifarotene) 50μg/g cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02566369

RD.06.SPR.18251

Details and patient eligibility

About

Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.

Full description

Clinical Trial for each subject is approximately 14 weeks and are randomized to one of the two treatments for 12 weeks. Subjects must be 9 years of age and older with acne vulgaris.

Enrollment: 1,208 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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 month 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 ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., 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 trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,208 participants in 2 patient groups, including a placebo group

CD5789 (trifarotene) 50μg/g Cream

Experimental group

Description:

CD5789 (trifarotene) 50μg/g Cream

Treatment:

Drug: CD5789 (trifarotene) 50μg/g cream

Placebo Cream

Placebo Comparator group

Description:

Placebo cream

Treatment:

Drug: Placebo cream