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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02556788
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: Galderma R&D
• Public title: Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
• Scientific title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
• Date of first enrolment: November 2015
• Target sample size: 1212
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02556788
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia, Hungary, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: Kevin Chan
• Affiliation: Galderma R&D

Key inclusion & exclusion 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 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



Age minimum: 9 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: CD5789 (trifarotene) 50µg/g Cream

Drug: Placebo Cream

Primary Outcome(s)

Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) [Time Frame: From Baseline to Week 12]

Secondary ID(s)

RD.06.SPR.18252

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02556788