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21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01430312
First received: September 6, 2011
Last updated: October 21, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: azelaic acid pre-foam formulation
Drug: Vehicle pre-foam formulation
Drug: Water
Drug: Sodium lauryl sulfate
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:
  • irritancy rating scale [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    skin reaction as well as superficial layer effects will be scored according to standardized scales


Study Start Date: September 2011
Arms Assigned Interventions
Experimental: Verum Drug: azelaic acid pre-foam formulation
Placebo Comparator: Vehicle Drug: Vehicle pre-foam formulation
Placebo Comparator: Negative control Drug: Water
Active Comparator: Positive control Drug: Sodium lauryl sulfate

Detailed Description:

This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.

  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 ore 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: NCT01430312

Locations
United States, North Dakota
Robert I. Cooper, MD
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Intendis GmbH
  More Information

No publications provided

Responsible Party: Intendis GmbH
ClinicalTrials.gov Identifier: NCT01430312     History of Changes
Other Study ID Numbers: 1401841
Study First Received: September 6, 2011
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Intendis GmbH:
dermal irritative potential

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

ClinicalTrials.gov processed this record on May 16, 2013