Pilot study: Role of anti-oxidants in the elicitation of contact allergic reaction to p-phenylenediamine (PPD).

Completed

• Conditions: Contact dermatitis; contact allergy; 10014982

• Registration Number: NL-OMON40582
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

• A history of (mild, moderate or severe) allergic contact dermatitis after exposure to a PPD-containing product (mostly hair dye)
• A positive patch-test to PPD (1% in white petrolatum)
• Adulthood (>=18 years)
• Legal competence
• Participated in one of the previous studies from the UMCG concerning PPD (METc 2007.230)

Exclusion Criteria

- Skin anomalies on the forearm
- Severe skinanomalies elsewhere on the body
- Immunosuppressive medication during or in the previous 4 weeks of the study
- (wish to become) pregnant
- Legally incompetent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the difference in the result of the skin reaction on day<br /><br>3 (72 hours) between the test area with only 2% PPD and the test area with<br /><br>pretreatment with the anti-oxidant solution, followed by 2% PPD.<br /><br><br /><br>Reading of the reactions will be accordance with the criteria of the ICDRG<br /><br>scored as -, ?, +, ++ or +++</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The remaining test areas are control areas to exclude allergic reactions to<br /><br>other ingredients from the hair dye or the anti-oxidant solution. </p><br>