NCT00311454

Brief Summary

The study is required by the FDA as part of a post-marketing commitment. The purpose of the study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use exposure.The subjects will wear the patch test for 48 hours and reading will be performed day 3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions from respectively TRUE Test and use test will be compared using the McNemar Change Test.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

April 6, 2006

Status Verified

April 1, 2006

First QC Date

April 4, 2006

Last Update Submit

April 4, 2006

Conditions

Allergic Contact Dermatitis Towards Quaternium-15

Interventions

T.R.U.E.TestDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sensitivity to quaternium-15
  • Age more than 18 years

You may not qualify if:

  • Topical or systemic treatment with corticosteroids or immunosuppresives.
  • Treatment with UV-light
  • Widespread active dermatitis or dermatitis on test area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amtssygehuset i Gentofte

Gentofte Municipality, Gentofte, 2900, Denmark

Location

Central Study Contacts

Torkil Menné, Prof.

CONTACT

+4539773200

Jacob Thyssen, Ph.D

CONTACT

+4539773200

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

April 1, 2006

Last Updated

April 6, 2006

Record last verified: 2006-04

Locations

DK(1)