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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 2009

Interventions

  • 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

Primary Measures

  • Efficacy of UVA-1 treatment vs. topical steroid.
    • Time Frame: 5 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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