NCT00643214

Brief Summary

To determine if Tetrix Cream,, when applied to the skin lesions on patients with contact dermatitis, slows or interferes with the healing of the lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day 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

1 month

First QC Date

March 20, 2008

Last Update Submit

May 19, 2008

Conditions

Healthy

Keywords

Tetrix CreamAntigen reactioneffect on healingTo determine if application of Tetrix Cream to lesions of contact dermatitis interferes with their rate of healing

Outcome Measures

Primary Outcomes (1)

  • Clearing of signs and symptoms of contact dermatitis

    10 days after induction of lesion and start of treatment

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+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal subjects with sensitivity to nickel.

You may not qualify if:

  • Under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Specialists, LLC

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Joseph Fowler, MD

    Dermatology Specialists, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
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

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

US(1)