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NCT01688531 Clinical Trial

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

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01688531
Other study ID # RD.03.SPR.40183E
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2012
Est. completion date September 2013

Study information
Verified date March 2016
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Other known NCT identifiers
  • NCT01718665

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Canada Galderma Investigational site Montreal Quebec
Canada Galderma Investigational site Windsor Ontario
France Galderma Investigational site Nantes

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

Canada,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Description and documentation of acne lesions over 6 months
Secondary Treatment effect on acne lesions over 6 months
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