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

Galderma

Status and phase: Completed; Phase 1

Conditions: Acne

Treatments: Drug: CD0271 0.1%/CD1579 2.5% gel vehicle; Drug: CD0271 0.1%/CD1579 2.5% gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01688531

RD.03.SPR.40183E

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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38 participants in 2 patient groups, including a placebo group

CD0271 0.1%/CD1579 2.5% gel

Experimental group

Description:

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

Treatment:

Drug: CD0271 0.1%/CD1579 2.5% gel vehicle

CD0271 0.1%/CD1579 2.5% gel vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: CD0271 0.1%/CD1579 2.5% gel