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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812188
First Posted: December 22, 2008
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heidi Jacobe, University of Texas Southwestern Medical Center
December 18, 2008
December 22, 2008
December 9, 2014
November 2004
November 2009   (Final data collection date for primary outcome measure)
Efficacy of UVA-1 treatment vs. topical steroid. [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT00812188 on ClinicalTrials.gov Archive Site
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Not Provided
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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.
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
Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Symmetric Limited Morphea.
  • 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.
  • 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.
    Intervention: Other: Medium Dose UVA-1
  • 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.
    Intervention: Other: High Dose UVA-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00812188
112004027
No
Not Provided
Not Provided
Heidi Jacobe, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Heidi Jacobe, M.D. UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP