NCT01430533

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 1, 2020

Status Verified

February 1, 2014

Enrollment Period

3 months

First QC Date

September 6, 2011

Last Update Submit

March 30, 2020

Conditions

Healthy

Keywords

dermal sensitization potential

Outcome Measures

Primary Outcomes (1)

  • skin sensitization reaction

    skin reactions will be assessed, using a standardized scoring scale

    day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)

Study Arms (3)

Verum

EXPERIMENTAL

Topical application of verum (azelaic acid pre foam formulation) on the skin

Drug: azelaic acid pre foam formulation

Vehicle

PLACEBO COMPARATOR

Topical application of vehicle formulation (same as verum but without active drug substance) on the skin

Drug: Vehicle pre foam formulation

Negative control

PLACEBO COMPARATOR

Topical application of distilled water (negative control) on the skin

Drug: Water

Interventions

azelaic acid pre foam formulationDRUG
Verum
Vehicle pre foam formulationDRUG
Vehicle
WaterDRUG
Negative control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers
  • male or female subjects
  • aged 18 - 65 years
  • ability to understand and fulfill the study requirements

You may not qualify if:

  • affected skin in designated test area
  • pregnancy or lactation
  • not willing to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert I. Cooper, MD

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 8, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 1, 2020

Record last verified: 2014-02

Locations

US(1)