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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430312

Enrollment

Registered

2011-09-08

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

dermal irritative potential

Brief summary

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

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.

Interventions

DRUGazelaic acid pre-foam formulation

DRUGVehicle pre-foam formulation

DRUGWater

DRUGSodium lauryl sulfate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
irritancy rating scale	21 days	skin reaction as well as superficial layer effects will be scored according to standardized scales

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026