A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

- Male or female, 9 years of age and older at Screening visit.

- 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.

- The subject has truncal acne severity grade of PGA 3 (moderate) at Screening and Baseline visits on the shoulders, anterior chest and upper back reachable to self-application of study drug by the subject (this inclusion criterion is optional for children between 9 and 11 years old).

- The subject has a minimum of 20 inflammatory lesions and 20 noninflammatory lesions at Screening and Baseline visits on the shoulders, upper back and anterior chest (this inclusion criterion is optional for children between 9 and 11 years old).
Are the trial subjects under 18? yes
Number of subjects for this age range: 108
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 more than 1 nodule on the trunk at Screening and at Baseline visits.

- The Subject has any acne cyst on the face at Screening and at Baseline visits.

- The Subject has any acne cyst on the trunk at Screening and at Baseline visits.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety and efficacy of CD5789 50µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris.;Secondary Objective: Efficacy will be evaluated as a secondary objective.;Primary end point(s): Safety:<br>1- assessment of local tolerability on treated areas and adverse events,<br>2- vital signs and physical eamination,<br>3- and laboratory tests;Timepoint(s) of evaluation of this end point: 1- at each visit<br>2- at Screening, baseline, WE12, W26 and W52<br>3- at Screening, baseline, W26 and W52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy :<br>- success rate of IGA, <br>- success rate of PGA, <br>- grade change from baseline of PGA,<br>- grade change from baseline of IGA, <br>- subject's assessement;Timepoint(s) of evaluation of this end point: at each time point

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