Condition category
Skin and Connective Tissue Diseases
Date applied
29/03/2016
Date assigned
31/03/2016
Last edited
31/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Paraphenylenediamine (PPD) is a chemical that is a common ingredient in permanent hair dye. Allergies to PPD are relatively common and use of products containing PPD can trigger an allergic reaction called contact dermatitis, in which the skin becomes inflamed (swollen), where the product has touched it. 2-Methoxymethyl-p-phenylenediamine (ME-PPD) is a PPD derivative which has recently been developed. Studies have shown that ME-PPD may be less allergenic (likely to cause an allergic reaction), and so products containing ME-PPD rather than PPD could be a good alternative to those with PDD allergies. The aim of this study is to compare the allergenic effects of PPD and ME-PPD on people who are allergic to PPD.

Who can participate?
Adults with a PPD allergy

What does the study involve?
All participants attend a total of three clinic visits over the course of one week. On the first visit, participants have an allergy test in which three different chemicals (PPD, ME-PPD and a control substance that does not contain any dye chemicals) are applied to the skin on the right arm. After thirty minutes, the chemicals are washed off and examined to see if there has been a skin reaction. These sites are also examined on the second and third visit (48 and 72 hours). At the first study visit, a sticky disc coated with ME-PPD is also placed on the participants back and left in place for 48 hours (the second study visit), at which time it is removed and the skin examined for signs of an allergic reaction.

What are the possible benefits and risks of participating?
There are no direct benefits to participants taking part in this study. There is a risk that participants will experience skin irritation, discomfort and itchiness during and after the patch test.

Where is the study run from?
University of Maryland, Baltimore (USA)

When is the study starting and how long is it expected to run for?
December 2014 to December 2015

Who is funding the study?
Procter and Gamble GmbH (Germany)

Who is the main contact?
Dr Anthony Gaspari
agaspari@som.umaryland.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Gaspari

ORCID ID

http://orcid.org/0000-0003-3453-0774

Contact details

Department of Dermatology
University of Maryland Baltimore
419 W. Redwood St.
Baltimore
21030
United States of America
+1 410 294 9053
agaspari@som.umaryland.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Me-PPD Study

Study hypothesis

Methoxymethyl p-phenylene diamine (PPD) is a safe, well-tolerated hair dye in PPD allergic subjects.

Ethics approval

Institutional Review Board of the University of Maryland Baltimore, 03/12/2014, ref: HP-00060991

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Allergic contact dermatitis

Intervention

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 well as the hydrogen peroxide solution (6% (w/w) Welloxon) will be provided by P&G. The hair dye test product will be always freshly prepared by mixing the tint (containing ME-PPD and the couplers) with the hydrogen peroxide solution using a small wooden stick (1:1, 90 microliters each). An amount of 100 microliters of the finished ME-PPD containing product is applied to the filter paper of the van der Bend ChambersĀ® (Brielle, the Netherlands, 1 cm2) using a pipette (infinite dose, 100 mg/cm2). A dye-free test product was used as control. The filled chambers were removed from the tape and directly placed on the skin of the lower arms. The chambers were additionally re-secured in the same position with 2 small stripes of tape (3M) across the plastic connections attached to the chamber (occlusion). After 30 minutes the formulations were gently rinsed off with a commercial shampoo and water to simulate hair dyeing use conditions. Responses were recorded at day 2 (D2, first reading after 48h) and day 3 (D3, second reading after 72h) and graded according to the ICDRG criteria.

Intervention type

Device

Phase

Drug names

Primary outcome measures

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 outcome measures

No secondary outcome measures.

Overall trial start date

03/12/2014

Overall trial end date

02/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

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

Recruitment start date

05/01/2015

Recruitment end date

02/11/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

University of Maryland
Department of Dermatology 419 W. Redwood St., Ste. 260
Baltimore
21201
United States of America

Sponsor information

Organisation

Procter and Gamble GmbH

Sponsor details

Sulzbacher StraBe 40
Schwalbach am Taunas
65824
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Procter and Gamble GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in JAMA Dermatology.

Intention to publish date

01/09/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes