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

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ClinicalTrials.gov Identifier: NCT01430533
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.

Condition or disease Intervention/treatment Phase
Healthy Drug: azelaic acid pre foam formulation Drug: Vehicle pre foam formulation Drug: Water Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
    skin reactions will be assessed, using a standardized scoring scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01430533     History of Changes
Other Study ID Numbers: 15854
1401842 ( Other Identifier: Company Internal )
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Bayer:
dermal sensitization potential

Additional relevant MeSH terms:
Azelaic acid
Antineoplastic Agents
Dermatologic Agents