Studying the Effects of 50µg/g Cream versus Placebo on Patients who have Acne

Phase 1

• Conditions: Acne Vulgaris; MedDRA version: 20.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-002860-15-CZ
• Lead Sponsor: Galderma R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-11
• Study Completion: 2017-11-14
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1208

Inclusion Criteria

- Male or female, 9 years of age and older), at the Screening visit. For Russia: Male or female, 9-17 years of age OR 18 years and older, at the
Screening visit
- The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
- The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 622
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- The subject has more than 1 nodule on the face at Screening and Baseline.
- The subject has more than 1 nodule on the trunk at Screening and Baseline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks in subjects with moderate facial and truncal<br>acne vulgaris.;Secondary Objective: Not applicable;Primary end point(s): 1) Success Rate, defined as the percentage of subjects who achieve an<br>IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade<br>improvement<br>2) Absolute Change in facial non-inflammatory lesion count.<br>3) Absolute Change in facial inflammatory lesion count;Timepoint(s) of evaluation of this end point: 1) from Baseline to Week 12<br>2) from Baseline to Week 12<br>3) from Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Percentage of subjects who achieve a PGA score of 1 (Almost Clear)<br>or 0 (Clear) and at least a 2 grade improvement<br>2) Absolute change in truncal non-inflammatory lesion count<br>3) Absolute change in truncal inflammatory lesion count;Timepoint(s) of evaluation of this end point: 1) from Baseline to Week 12<br>2) from Baseline to Week 12<br>3) from Baseline to Week 12