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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00812188
First received: December 18, 2008
Last updated: December 19, 2008
Last verified: September 2008

December 18, 2008
December 19, 2008
November 2004
November 2009   (final data collection date for primary outcome measure)
Efficacy of UVA-1 treatment vs. topical steroid. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00812188 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Active, not recruiting
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812188
112004027
No
Heidi Jacobe, M.D. - Assistant Professor of Dermatology, UT Southwestern Medical Center at Dallas
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
September 2008

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