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

September 16, 2019 updated by: Galderma R&D
Exploratory, international, multi-centre, randomized, investigator blinded study in acne

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Windsor, Ontario, Canada
        • Galderma Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • Galderma Investigational Site
  • France
      • Nantes, France
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description and documentation of acne lesions
Time Frame: over 6 months
over 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment effect on acne lesions
Time Frame: over 6 months
over 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.40183E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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