The Allergy Alert Test, a proof of concept study

Completed

Conditions: Allergic contact dermatitis
contact eczema
10014982

Registration Number: NL-OMON38497

Lead Sponsor: 'Oréal

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Study subjects with PPD sensitization:
• Males and females, 18-65 years of age;
• Consecutively patch tested patients, who have shown positive reactions to PPD (+, ++ and +++) within the last 5 years included in the database of the department Dermatology;
• Clinical relevance of the positive patch test reaction: self-declared past exposure to oxidation hair dyes and clinical manifestations compatible with contact sensitivity to hair dyes (documented in CRF). All patients will be required to provide information on the approximate shade (light, medium or dark) responsible for their reaction.
• Healthy skin on the test site for at least 3 months on entering the study;
• Legal competent;PPD-negative subject must meet all of the following criteria:
• Consecutively patch tested patients, males and females, oxidative hair dye consumers, 18-65 years of age, who have shown negative reactions to PPD and to all other tested allergens with the exception of nickel (tests carried out 12 months to 3 weeks before inclusion into the study);
• Sex and age-matched (within 5 years), whenever possible, to test subjects;
• No history of adverse reactions to hair colouring products;
• Healthy skin on the test site for at least 3 months;
• Legal competent

Exclusion Criteria

• Hairdressers; current or past occupation
• Current acute or widespread eczema at any site, any eczema on the test sites within the last 3 months before study;
• Significant past medical history which in the opinion of the investigator can interfere with the study;
• Febrile illness lasting more than 24 hours in the six days prior to each patch application;
• Past or concomitant medication likely to affect the response to the test articles or confuse the results of the study (systemic treatment: corticosteroid or immunosuppressive 1 month prior and during the study);
• Recent vaccination (less than 3 weeks prior to patch application);
• Insulin-dependent diabetes;
• Recent history of extensive sun exposure;
• Deliberate exposure of the test sites to natural sunlight or artificial sources of UV light in the two weeks preceding the study, during the study, and during the two weeks following the study;
• Participation in a diagnostic patch test during the six preceding weeks for PPD-positive subjects and during the three preceding weeks for PPD-negative subjects;
• Pregnancy or breast feeding or active childwish

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The result of the Skin Self Test, read by a dermatologist.<br /><br>The reaction will be scored according to a strict protocol: negative (-),<br /><br>positive (+, ++ or +++), irritant (IR) or doubtful (?) reaction, for which all<br /><br>positive reactions will be considered as POSITIVE, whereas the doubtful,<br /><br>negative and irritant reactions will be considered as NEGATIVE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The result of the Skin Self Test, interpretated by the study subject. Graded<br /><br>negative (no reaction at all) or positive (some kind of reaction)<br /><br>- Agreement between independent test evaluations of the dermatologist and the<br /><br>study subject.<br /><br>- The result of the Skin Self Test graded by the dermatologist scored as<br /><br>negative (-), positive (+, ++ or +++), irritant (IR) or doubtful (?) reaction<br /><br><br /><br>The influence of:<br /><br>- Product applied: hair colouring formula mixed with developer (in use ratio)<br /><br>- Reading time:<br /><br>a) dermatological evaluation at 15 - 20 minutes after test removal, Day 2,<br /><br>Day 4 and later if considered necessary<br /><br>b) independent daily self-evaluation by subjects: 15 - 20 minutes after test<br /><br>removal, Day 1, Day 2, Day 3 Day 4 and later if neces-sary.<br /><br>- Site: retro-auricular region versus volar aspect of forearms</p><br>