ot applicable

Phase 1

Conditions: Acne vulgaris
MedDRA version: 19.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2016-000063-16-DE

Lead Sponsor: Galderma R&D SNC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. The subject is a male or a female aged from 18 to 35 years old before screening visit.
2. The subject has a medical diagnosis of acne vulgaris defined by :
2.1. at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) (Screening and Baseline)
2.2. symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side
3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).

2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.

3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator’s Brochure/Product label).

4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective of the study is to evaluate the safety of CD5024 1% cream applied once daily 5 days a week over a 6-week treatment period compared to its vehicle in adult patients suffering from acne vulgaris.;Main Objective: The primary objective of the study is to evaluate the efficacy of CD5024 1% cream applied once daily 5 days a week over a 6-week treatment period compared to its vehicle in adult patients suffering from acne vulgaris.;Primary end point(s): Efficacy: Inflammatory acne lesion count per half face;Timepoint(s) of evaluation of this end point: at day 40

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Inflammatory acne lesion count and percent reduction per half face<br>- Total acne lesion count and percent reduction per half face<br>- Non-inflammatory lesion count and percent reduction per half face;Timepoint(s) of evaluation of this end point: At each evaluation visit