Study Completed

Healthy

Bayer Identifier:

15854

ClinicalTrials.gov Identifier:

NCT01430533

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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 summary

Enrollment Goal

240

Trial Dates

September 2011 - December 2011

Phase

Phase 1

Could I Receive a placebo

Products

Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Robert I. Cooper, MD	Fargo, 58104, United States

Primary Outcome

skin sensitization reaction
skin reactions will be assessed, using a standardized scoring scale
Time Frame:
day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
Safety Issue:
Yes

Trial design

A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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