Quaternium-15, Use Test | NCT00311454

Studies
Quaternium-15, Use Test

NCT00311454

Sponsor

Mekos Laboratories AS

Status

Unknown status

Last Update Posted

Apr 6, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Allergic Contact Dermatitis Towards Quaternium-15

Interventions

T.R.U.E.Test

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 4, 2006

First Submission Date that Met QC Criteria

Apr 4, 2006

First Posted Date

Apr 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2006

Last Update Posted Date

Apr 6, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
T.R.U.E.Test	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sensitivity to quaternium-15
Age more than 18 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Torkil Menné, Prof.	Contact	+4539773200
Jacob Thyssen, Ph.D	Contact	+4539773200

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amtssygehuset i Gentofte		Gentofte Municipality	Gentofte	2900	Denmark