A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age9+
SponsorGalderma R&D

About this trial

The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.

Eligibility criteria

Qualifiers

Male or female Chinese participants aged 9 years or older at the screening visit.

A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline.

Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline.

A minimum of 20 inflammatory lesions and 20 non-inflammatory lesions but no more than 100 non-inflammatory lesion counts on the trunk (shoulders, upper back, and upper anterior chest) reachable for self-application of investigational product by the participant at Screening and Baseline (optional criterion for participant between 9 and 11 years of age).

Disqualifiers

Pregnant women (positive serum pregnancy test result at the screening visit or positive UPT at the baseline visit), breastfeeding women, or women planning a pregnancy during the study or within 1 month after the last investigational product application.

Severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g., chloracne, drug-induced acne) at the screening and baseline visits.

More than 1 nodule on the face at the screening and baseline visits.

More than 1 nodule on the trunk at the screening and baseline visits.

Trial design

Treatments tested in this trial

  • Trifarotene
  • Vehicle Cream

Treatment groups

561 Participants
are divided into 2 treatment groups

Sponsors and collaborators