Study on Hypoallergenic Hair Dye

NCT ID: NCT04772482

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-05-13

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.

Detailed Description

For patients with PPD sensitizations, it is important to find alternatives for dark hair dyes. P-toluenediamine (PTD) and potentially also 2-methoxyethyl p-phenylenediamine (ME-PPD) show cross-reactivity with PPD and therefore we want to prove that our new compounds PPD-6 and PPD-7 show no or significantly reduced cross-reactions with PPD and do not induce relevant allergic reactions in patients with proven PPD sensitizations.

Our specific aims for this study are the following:

A1) To show that PPD 6 and PPD 7 have reduced or optimally no reaction in standard patch tests in patients with proven allergy to PPD A2) To compare the sensitization pattern to other possible commercially available alternatives for hair dye, such as ME-PPD and PTD A3) To evaluate and rule out any possible non-specific irritant reaction of PPD-6 and PPD-7 in these patch tests (i.e. confirm in-vitro safety profile in-vivo)

Conditions

Contact Dermatitis; Allergy; Dermatitis; Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

All participants will undergo path testing to determine skin sensitivity to certain compounds.

Sensitivity Patch Testing

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Sensitivity Patch Testing

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Bigliardi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

DERM-2020-29233

Identifier Type: -

Identifier Source: org_study_id