Overview

This trial is active, not recruiting.

Condition acne vulgaris
Treatment cd5789
Phase phase 3
Sponsor Galderma R&D
Start date February 2015
End date February 2017
Trial size 455 participants
Trial identifier NCT02189629, RD.06.SPR.18250

Summary

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cd5789

Primary Outcomes

Measure
Assessment of Local tolerability and Adverse Event at each visit
time frame: up to 52 weeks

Eligibility Criteria

Male or female participants at least 9 years old.

Inclusion Criteria: - The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits. - The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face. - Exclusion Criteria: - The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.). - The Subject has more than 1 nodule on the face at Screening and at Baseline visits. - The Subject has any acne cyst on the face at Screening and at Baseline visits.

Additional Information

Official title A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
Description To determine the safety and efficacy of CD5789 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Galderma R&D.