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

Symmetric Limited Morphea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812188
• Other study ID #: 112004027
• Status: Completed
• Phase: N/A
• Start date: November 2004
• Est. completion date: November 2009

Study information

• Verified date: December 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Localized
• Symmetric Limited Morphea

Intervention

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

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of UVA-1 treatment vs. topical steroid.		5 years