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Study on Hypoallergenic Hair Dye

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ClinicalTrials.gov Identifier: NCT04772482
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : March 7, 2023
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment
Contact Dermatitis Allergy; Dermatitis Dermatitis Diagnostic Test: Sensitivity Patch Testing

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)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Testing of Alternatives for Dark Hair Dyes in Patients With Proven Sensitization to Para-Phenylenediamine
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
All Participants
All participants will undergo path testing to determine skin sensitivity to certain compounds.
Diagnostic Test: 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.

Primary Outcome Measures :
  1. Allergy to Study Compounds [ Time Frame: 4 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with sensitivity to PPD and/or PTD

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772482

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Contact: Paul Bigliardi, MD 952 594 9767 pbigliar@umn.edu

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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Paul Bigliardi, MD         
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Paul Bigliardi, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04772482    
Other Study ID Numbers: DERM-2020-29233
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases