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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01430533
First received: September 6, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: azelaic acid pre foam formulation
Drug: Vehicle pre foam formulation
Drug: Water
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • skin sensitization reaction [ Time Frame: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase) ] [ Designated as safety issue: Yes ]
    skin reactions will be assessed, using a standardized scoring scale


Enrollment: 240
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
Topical application of verum (azelaic acid pre foam formulation) on the skin
Drug: azelaic acid pre foam formulation
Placebo Comparator: Vehicle
Topical application of vehicle formulation (same as verum but without active drug substance) on the skin
Drug: Vehicle pre foam formulation
Placebo Comparator: Negative control
Topical application of distilled water (negative control) on the skin
Drug: Water

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430533

Locations
United States, North Dakota
Robert I. Cooper, MD
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01430533     History of Changes
Other Study ID Numbers: 15854, 1401842
Study First Received: September 6, 2011
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
dermal sensitization potential

Additional relevant MeSH terms:
Azelaic acid
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014