Allergy; Dermatitis, Contact Dermatitis, Dermatitis
Conditions
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)
Interventions
DIAGNOSTIC_TESTSensitivity 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.
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allergy to Study Compounds | 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. |
Countries
United States
Outcome results
None listed