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

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ClinicalTrials.gov Identifier: NCT01688531
Recruitment Status : Completed
First Posted : September 20, 2012
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : August 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Description and documentation of acne lesions [ Time Frame: over 6 months ]

Secondary Outcome Measures :
  1. Treatment effect on acne lesions [ Time Frame: over 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688531


Locations
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Canada, Ontario
Galderma Investigational site
Windsor, Ontario, Canada
Canada, Quebec
Galderma Investigational site
Montreal, Quebec, Canada
France
Galderma Investigational site
Nantes, France
Sponsors and Collaborators
Galderma R&D
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01688531    
Obsolete Identifiers: NCT01718665
Other Study ID Numbers: RD.03.SPR.40183E
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: March 2016
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases