Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT00640250
Brief Summary:
We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
Detailed Description:
Primary endpoint:
To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
* Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
* Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
* Concordance/discordance as compared to the corresponding reference petrolatum allergen.
Secondary endpoint:
To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
* The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning.
* The frequency and characterization of adverse events and serious adverse events.
* The frequency and characterization of late and/or persistent reactions.
Study:
NCT00640250
Study Brief:
Protocol Section:
NCT00640250