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

NCT ID: NCT01688531

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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CD0271 0.1%/CD1579 2.5% gel

Split-face design, one application a day for 6 months

Group Type EXPERIMENTAL

CD0271 0.1%/CD1579 2.5% gel vehicle

Intervention Type DRUG

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

Split-face design, one application a day for 6 months

Group Type PLACEBO_COMPARATOR

CD0271 0.1%/CD1579 2.5% gel

Intervention Type DRUG

one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Galderma Investigational site

Windsor, Ontario, Canada

Site Status

Galderma Investigational site

Montreal, Quebec, Canada

Site Status

Galderma Investigational site

Nantes, , France

Site Status

Countries

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Canada France

Other Identifiers

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RD.03.SPR.40183E

Identifier Type: -

Identifier Source: org_study_id

NCT01718665

Identifier Type: -

Identifier Source: nct_alias

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