Study on Hypoallergenic Hair Dye
Testing of Alternatives for Dark Hair Dyes in Patients With Proven Sensitization to Para-Phenylenediamine
1 other identifier
observational
8
1 country
1
Brief Summary
Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of p-phenylenediamine (PPD) with less allergy potential.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2021
1 active site
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
First Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2022
CompletedAugust 25, 2023
August 1, 2023
1.1 years
February 23, 2021
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Allergy to Study Compounds
The primary endpoint of the study is the percent of participants with a known PPD allergy who experience an allergic reaction to the study compounds PPD6 or PPD7.
4 days
Study Arms (1)
All Participants
All participants will undergo path testing to determine skin sensitivity to certain compounds.
Interventions
Testing patches will be applied on the upper arms. Para-phenylene diamine (PPD) 1% will be applied on one upper arm. Para-toluenediamine sulfate (PTD), 2-methoxyethyl p-phenylenediamine (ME-PPD), PPD6 and PPD7 will be applied to the other upper arm.
Eligibility Criteria
Adults with sensitivity to PPD and/or PTD
You may qualify if:
- \- Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)
You may not qualify if:
- Use of oral immunosuppressive, anti-inflammatory and chemotherapy medications, particularly corticosteroids for at least 1 month before testing.
- Immunocompromised patient (e.g. Cancer, Diabetes mellitus, medication, Immunodeficiency, radiation therapy)
- History of acute hepatitis, chronic liver disease or end stage liver disease.
- History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
- Use of illicit drugs within the past 6 months prior to study start and/or opioid use disorder.
- Pregnancy as established by questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55404, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Bigliardi, MD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2021
First Posted
February 26, 2021
Study Start
April 1, 2021
Primary Completion
May 13, 2022
Study Completion
May 13, 2022
Last Updated
August 25, 2023
Record last verified: 2023-08