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 Chambers® (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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list