NCT00646867

Brief Summary

To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

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

February 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

Same day

First QC Date

March 26, 2008

Last Update Submit

May 19, 2008

Conditions

Contact Dermatitis

Keywords

Tetrix cream, contact dermatitis, effect on burning and itching

Outcome Measures

Primary Outcomes (1)

  • Improvement in symptoms of burning and itching.

    after 14 days of treatment

Study Arms (2)

1

EXPERIMENTAL

Experimental

Device: Tetrix

2

PLACEBO COMPARATOR

Placebo

Device: Placebo

Interventions

TetrixDEVICE

Twice daily topical application

1
PlaceboDEVICE

Twice daily topical application

2

Eligibility Criteria

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

You may qualify if:

  • Normal subjects with sensitivity to nickel
  • Subjects with hand eczema

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

MeSH Terms

Conditions

Dermatitis, ContactPruritus

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

US(1)