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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.

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ClinicalTrials.gov Identifier: NCT00812188
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
Heidi Jacobe, University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment Phase
Symmetric Limited Morphea. Other: Medium Dose UVA-1 Other: High Dose UVA-1 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : November 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009


Arm Intervention/treatment
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.
Other: Medium Dose UVA-1
UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 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.
Other: High Dose UVA-1
High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.



Primary Outcome Measures :
  1. Efficacy of UVA-1 treatment vs. topical steroid. [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812188


Locations
United States, Texas
UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Heidi Jacobe, M.D. UT Southwestern Medical Center at Dallas

Responsible Party: Heidi Jacobe, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00812188     History of Changes
Other Study ID Numbers: 112004027
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Heidi Jacobe, University of Texas Southwestern Medical Center:
Morphea
Plaque morphea
Localized Scleroderma

Additional relevant MeSH terms:
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Fluocinonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents