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

Not Applicable

Completed

• Conditions: Symmetric Limited Morphea
• Interventions: Other: High Dose UVA-1; Other: Medium Dose UVA-1

• Registration Number: NCT00812188
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2014-12
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose UVA-1	High Dose UVA-1	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.
Medium Dose UVA-1	Medium Dose UVA-1	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of UVA-1 treatment vs. topical steroid.	5 years

Trial Locations

Locations (1)

UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials; 🇺🇸 Dallas, Texas, United States