Safety of a PPD-Hair dye derivative in PPD-allergic subjects
| ISRCTN | ISRCTN13869335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13869335 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/03/2016
- Registration date
- 31/03/2016
- Last edited
- 18/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Dermatology
University of Maryland Baltimore
419 W. Redwood St.
Baltimore
21030
United States of America
 ORCID ID |
0000-0003-3453-0774 |
|---|---|
| Phone | +1 410 294 9053 |
| agaspari@som.umaryland.edu |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Tolerability of 2-methoxymethyl-p-phenylenediamine in p-phenylenediamine Allergic Volunteers using Allergy Alert Test: A Pilot Study |
| Study acronym | Me-PPD Study |
| Study objectives | Methoxymethyl p-phenylene diamine (PPD) is a safe, well-tolerated hair dye in PPD allergic subjects. |
| Ethics approval(s) | Institutional Review Board of the University of Maryland Baltimore, 03/12/2014, ref: HP-00060991 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 03/12/2014 |
| Completion date | 02/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Aged 18 years and over 2. History of hair dye intolerance 3. Positive patch test to PPD |
| Key exclusion criteria | 1. Life threatening diseases 2. Poor health 3. Anaphylaxis to PPD |
| Date of first enrolment | 05/01/2015 |
| Date of final enrolment | 02/11/2015 |
Locations
Countries of recruitment
- United States of America
Study participating centre
419 W. Redwood St., Ste. 260
Baltimore
21201
United States of America
Sponsor information
Industry
Sulzbacher StraBe 40
Schwalbach am Taunas
65824
Germany
"ROR" |
https://ror.org/02t2pyr24 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in JAMA Dermatology. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2016 | 18/11/2021 | Yes | No |
Editorial Notes
18/11/2021: Publication reference and total final enrolment added.
