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Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.

Primary Purpose

Symmetric Limited Morphea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medium Dose UVA-1
High Dose UVA-1
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symmetric Limited Morphea focused on measuring Morphea, Plaque morphea, Localized Scleroderma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects 18 years of age or older.
  • Symmetric limited morphea.

Exclusion Criteria:

  • Known sensitivity to fluocinonide 0.05% cream.
  • Clinical evidence of superinfected skin.
  • Immunocompromised state (including previously documented HIV).
  • Generalized Scleroderma.
  • Previous history of skin cancer.
  • Non-English speaking subjects.

Sites / Locations

  • UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medium Dose UVA-1

High Dose UVA-1

Arm Description

Medium dose (60 J/cm2) UVA-1 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream to another morphea plaque twice daily for twelve weeks.

High dose UVA-1 treatment 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream twice daily for 12 weeks to another morphea plaque.

Outcomes

Primary Outcome Measures

Efficacy of UVA-1 treatment vs. topical steroid.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2008
Last Updated
February 14, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00812188
Brief Title
Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.
Official Title
A Prospective, Open Label Trial of High Dose UVA-1, 3x/Week or Medium Dose UVA-1, 3x/Week vs. Fluocinonide 0.05% Cream Treatment of Morphea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symmetric Limited Morphea
Keywords
Morphea, Plaque morphea, Localized Scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medium Dose UVA-1
Arm Type
Active Comparator
Arm Description
Medium dose (60 J/cm2) UVA-1 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream to another morphea plaque twice daily for twelve weeks.
Arm Title
High Dose UVA-1
Arm Type
Active Comparator
Arm Description
High dose UVA-1 treatment 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream twice daily for 12 weeks to another morphea plaque.
Intervention Type
Other
Intervention Name(s)
Medium Dose UVA-1
Intervention Description
UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
High Dose UVA-1
Intervention Description
High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.
Primary Outcome Measure Information:
Title
Efficacy of UVA-1 treatment vs. topical steroid.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects 18 years of age or older. Symmetric limited morphea. Exclusion Criteria: Known sensitivity to fluocinonide 0.05% cream. Clinical evidence of superinfected skin. Immunocompromised state (including previously documented HIV). Generalized Scleroderma. Previous history of skin cancer. Non-English speaking subjects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Jacobe, M.D.
Organizational Affiliation
UT Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.

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