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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40582

Enrollment

Registered

2014-05-09

Start date

2014-04-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact dermatitis contact allergy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The remaining test areas are control areas to exclude allergic reactions to other ingredients from the hair dye or the anti-oxidant solution.	—

Countries

Netherlands

Outcome results