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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: azelaic acid pre foam formulation (Drug); Vehicle pre foam formulation (Drug); Water (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: skin sensitization reaction

Detailed 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Robert I. Cooper, MD, Fargo, North Dakota 58104, United States
Additional Information

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Starting date: September 2011
Last updated: February 27, 2014

Page last updated: August 20, 2015

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