Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01430312
First received: September 6, 2011
Last updated: February 27, 2014
Last verified: February 2014

September 6, 2011
February 27, 2014
September 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01430312 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: azelaic acid pre-foam formulation
  • Drug: Vehicle pre-foam formulation
  • Drug: Water
  • Drug: Sodium lauryl sulfate
  • Experimental: Verum
    Topical application of verum (azelaic acid pre-foam formulation) on the skin
    Intervention: 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
    Intervention: Drug: Vehicle pre-foam formulation
  • Placebo Comparator: Negative control
    Topical application of distilled water (negative control) on the skin
    Intervention: Drug: Water
  • Active Comparator: Positive control
    Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin
    Intervention: Drug: Sodium lauryl sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430312
15853, 1401841
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP