Safety of a PPD-Hair dye derivative in PPD-allergic subjects

Tolerability of 2-methoxymethyl-p-phenylenediamine in p-phenylenediamine Allergic Volunteers using Allergy Alert Test: A Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13869335

Enrollment

Registered

2016-03-31

Start date

2015-01-05

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic contact dermatitis Skin and Connective Tissue Diseases Allergic contact dermatitis

Interventions

The vehicle (Koleston Perfect formula without fragrance) containing the hair dye precursor (4% ME-PPD, free base) and couplers (1.9% 2-methylresorcinol and 1.9% 2-methyl-5-hydroxyethylaminophenol), as

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over 2. History of hair dye intolerance 3. Positive patch test to PPD

Exclusion criteria

Exclusion criteria: 1. Life threatening diseases 2. Poor health 3. Anaphylaxis to PPD

Design outcomes

Primary

Measure	Time frame
Skin test reactivity is determined by Anthony Gaspari and Amir Zahir at baseline, 30 minutes, 48 and 72 hours using a standard contact dermatitis scoring system (ICDRG criteria).	—

Secondary

Measure	Time frame
No secondary outcome measures.	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026