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

The University of Texas System (UT)

Status: Completed

Conditions: Symmetric Limited Morphea

Treatments: Other: High Dose UVA-1; Other: Medium Dose UVA-1

Study type: Interventional

Funder types: Other

Identifiers

NCT00812188

112004027

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Medium Dose UVA-1

Active Comparator group

Description:

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.

Treatment:

Other: Medium Dose UVA-1

High Dose UVA-1

Active Comparator group

Description:

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.

Treatment:

Other: High Dose UVA-1