NCT00132600

Brief Summary

The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
Last Updated

October 19, 2005

Status Verified

August 1, 2005

First QC Date

August 19, 2005

Last Update Submit

October 18, 2005

Conditions

Allergic Contact Dermatitis

Keywords

Allergic contact dermatitisPatch testingbacitracin

Outcome Measures

Primary Outcomes (1)

  • Skin reaction to the patch test after 72-96 hours and after 7 days

Secondary Outcomes (2)

  • Evaluation of safety including late and persistent responses

  • Evaluation day 3/4, day 7 and day 21

Interventions

bacitracin (allergen)DRUG

Eligibility Criteria

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

You may qualify if:

  • Positive bacitracin patch test within the latest 5 years.
  • Age greater than or equal to 18 years.
  • Signed informed consent.

You may not qualify if:

  • Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
  • Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
  • Treatment with ultraviolet (UV)-light during the latest 3 weeks.
  • Widespread active dermatitis or dermatitis on test area.
  • Subjects not able to cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatological Clinic (Joseph Fowler MD)

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

BacitracinAllergens

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Joseph Fowler, Prof.

    Mekos Laboratories AS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

April 1, 2005

Study Completion

July 1, 2005

Last Updated

October 19, 2005

Record last verified: 2005-08

Locations

US(1)