NCT00643630

Brief Summary

To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable healthy

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

October 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

Same day

First QC Date

March 20, 2008

Last Update Submit

May 19, 2008

Conditions

Healthy

Keywords

Tetrix creaskin barrierantigen reactionpreventionThe efficacy of Tetrix Cream to prevent an antigen reaction on the skin.

Outcome Measures

Primary Outcomes (1)

  • Prevention of delayed bype hypersensitivity reaction following application of antigen

    up to 96 hours after antigen application

Study Arms (2)

1

EXPERIMENTAL

Twice daily topical application

Device: Tetrix

2

PLACEBO COMPARATOR

Twice daily topical application

Device: Tetrix

Interventions

TetrixDEVICE

Twice daily topical application

1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal subjects who are sensitized to nickel, neomycin, or fragrance mix.

You may not qualify if:

  • Under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatolgoy Specialists, LLC

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Joseph Fowler, MD

    Dermatology Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

US(1)