Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Vehicle pre foam formulation; Drug: Water; Drug: azelaic acid pre foam formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430533

1401842 (Other Identifier)

15854

Details and patient eligibility

About

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

Full description

In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers
• male or 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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240 participants in 3 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

Sponsors of this trial

Lead Sponsor

LEO Pharma

Collaborating Sponsor

Bayer