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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430533

Enrollment

240

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 sensitization potential

Brief summary

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

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.

Interventions

DRUGazelaic acid pre foam formulation

DRUGVehicle pre foam formulation

DRUGWater

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 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

Design outcomes

Primary

Measure	Time frame	Description
skin sensitization reaction	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

Countries

United States

Outcome results

None listed

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