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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01688531
• Collaborator: (none)
• Enrollment: 38
• Locations: 3
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 12.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acne	Drug: CD0271 0.1%/CD1579 2.5% gel; Drug: CD0271 0.1%/CD1579 2.5% gel vehicle	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Basic Science
• Official Title: A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD0271 0.1%/CD1579 2.5% gel Split-face design, one application a day for 6 months	Drug: CD0271 0.1%/CD1579 2.5% gel vehicle; one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
Placebo Comparator: CD0271 0.1%/CD1579 2.5% gel vehicle Split-face design, one application a day for 6 months	Drug: CD0271 0.1%/CD1579 2.5% gel; one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months

Outcome Measures

Primary Outcome Measures

1. Description and documentation of acne lesions [over 6 months]

Secondary Outcome Measures

1. Treatment effect on acne lesions [over 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational site	Windsor	Ontario	Canada
2	Galderma Investigational site	Montreal	Quebec	Canada
3	Galderma Investigational site	Nantes		France

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01688531
• Other Study ID Numbers: RD.03.SPR.40183E; NCT01718665
• First Posted: Sep 20, 2012
• Last Update Posted: Sep 18, 2019
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Sep 18, 2019