Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.
Full Title of Study: “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
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Investigator)
- Study Primary Completion Date: November 2009
- Other: Medium Dose UVA-1
- UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.
- Other: High Dose UVA-1
- High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.
Arms, Groups and Cohorts
- Active Comparator: 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.
- Active Comparator: 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.
Clinical Trial Outcome Measures
- Efficacy of UVA-1 treatment vs. topical steroid.
- Time Frame: 5 years
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 99 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Provider of Information About this Clinical Study
- Principal Investigator: Heidi Jacobe, Principal Investigator – University of Texas Southwestern Medical Center
- Overall Official(s)
- Heidi Jacobe, M.D., Principal Investigator, UT Southwestern Medical Center at Dallas
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