21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: azelaic acid pre-foam formulation; Drug: Water; Drug: Vehicle pre-foam formulation; Drug: Sodium lauryl sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430312

1401841 (Other Identifier)

15853

Details and patient eligibility

About

The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

Full description

This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers
• male ore female subjects
• aged 18 - 65 years
• ability to understand and fulfill the study requirements

Exclusion criteria

• affected skin in designated test area
• pregnancy or lactation
• not willing to comply with study requirements

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Verum

Experimental group

Description:

Topical application of verum (azelaic acid pre-foam formulation) on the skin

Treatment:

Drug: azelaic acid pre-foam formulation

Vehicle

Placebo Comparator group

Description:

Topical application of vehicle formulation (same as verum but without active drug substance) on the skin

Treatment:

Drug: Vehicle pre-foam formulation

Negative control

Placebo Comparator group

Description:

Topical application of distilled water (negative control) on the skin

Treatment:

Drug: Water

Positive control

Active Comparator group

Description:

Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin

Treatment:

Drug: Sodium lauryl sulfate