A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients

Phase 1

Completed

• Conditions: Acne
• Interventions: Drug: CD0271 0.1%/CD1579 2.5% gel vehicle; Drug: CD0271 0.1%/CD1579 2.5% gel

• Registration Number: NCT01688531
• Lead Sponsor: Galderma R&D

Brief Summary

Exploratory, international, multi-centre, randomized, investigator blinded study in acne

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-03
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Male or female subjects aged 18 to 35 years inclusive
• Subjects with active, moderate acne

Exclusion Criteria

• The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
• The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD0271 0.1%/CD1579 2.5% gel	CD0271 0.1%/CD1579 2.5% gel vehicle	Split-face design, one application a day for 6 months
CD0271 0.1%/CD1579 2.5% gel vehicle	CD0271 0.1%/CD1579 2.5% gel	Split-face design, one application a day for 6 months

Primary Outcome Measures

Name	Time	Method
Description and documentation of acne lesions	over 6 months

Secondary Outcome Measures

Name	Time	Method
Treatment effect on acne lesions	over 6 months

Trial Locations

Locations (1)

Galderma Investigational site; 🇫🇷 Nantes, France