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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Symmetric Limited Morphea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Medium Dose UVA-1

Intervention Type OTHER

UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.

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.

Group Type ACTIVE_COMPARATOR

High Dose UVA-1

Intervention Type OTHER

High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.

Interventions

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Medium Dose UVA-1

UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.

Intervention Type OTHER

High Dose UVA-1

High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No