Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea

NCT01799174 | Completed

• 1 other identifier: 022012025
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, and controlled trial to assess the efficacy and safety of UVA1 phototherapy in the treatment of active morphea in adults and children. Forty patients will be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1 phototherapy) with an ultraviolet translucent acrylic screen or "sham" UVA1 (0 J/cm2) phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The phototherapists, patients, and principal investigator will be blinded to whether the patients receive active or sham UVA1 phototherapy. Patients will only be allowed to apply emollients during the study. Patients completing the randomized placebo controlled trial (RPCT) will be followed during an open observation period for 3 months. During the open phase, all outcome measures from the RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients who received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy using the same protocol as in the RPCT during the open observation. Adult patients enrolled in the RPCT will also be part of a nested translational study investigating the effect of UVA1 phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1) and after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in lesional skin before and after treatment as well as nonlesional skin.

Conditions

Scleroderma, Localized; Morphea; Scleroderma, Circumscribed

Outcome Measures

Primary Outcomes (1)

• To determine the effect of UVA1 phototherapy in patients with morphea using a validated clinical outcome measure, the Localized Scleroderma Severity Index (LoSSI)

  Forty patients will be randomized to receive either active (n=20) or sham (n=20) medium dose UVA1 phototherapy three times a week for 10 weeks followed by a 3 month open follow up. The primary outcome measure is mean change in Localized Scleroderma Severity Index (LoSSI), a validated clinical score of morphea activity, from baseline versus after 30 treatments.

  3 years

Secondary Outcomes (2)

• To determine the effect of UVA1 phototherapy on physician's global assessment of disease activity (PGA-A) in the same group of patients and controls.

  3 years

• To use gene expression profiling to characterize pathways and mechanisms that are involved in the therapeutic effect of UVA1 phototherapy.

  3 years

Study Arms (2)

UVA-1 Phototherapy

ACTIVE COMPARATOR

Receive medium dose UVA-1 (70 J/cm2) 3x/week for 10 weeks

Procedure: UVA-1 Phototherapy

Placebo

SHAM COMPARATOR

Receive "sham" UVA1 phototherapy (0 J/cm2) 3x/week for 10 weeks

Procedure: Placebo

Interventions

UVA-1 Phototherapy PROCEDURE

UVA-1 Phototherapy

Placebo PROCEDURE

Placebo

Eligibility Criteria

• Age: 6 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least one active morphea lesion (linear, plaque, generalized, or mixed subtypes) confirmed by the primary investigator and/or by histopathological examination. Morphea lesions are clinically distinctive and therefore biopsy will only be performed if the diagnosis is in doubt.
• Age \> 6 years at enrollment
• Male or female
• Patient or legal guardian must be able to speak and read English or Spanish at a 6th grade reading level. A translator will be available with additional consent forms in Spanish.
• Both male and female patients will be eligible
• All races and ethnic backgrounds will be included
• Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the study (if \> 10 -17 years).

You may not qualify if:

• Age \< 6 years at enrollment. (Patients under the age of 6 years will be excluded because study participants must be able to comply with the use of protective goggles and lie still during UVA1 phototherapy.)
• Presence of morphea profunda or eosinophilic fasciitis
• Contraindication to UVA1 phototherapy, including personal history of melanoma or non-melanoma skin cancer, history of photosensitive disorders (systemic lupus erythematosus, porphyrias, polymorphic light eruption, xeroderma pigmentosum, and the like), history of any type of organ transplant (solid organ or bone marrow).
• Current or \<2 months prior use of systemic immunosuppressive therapy (methotrexate, prednisone mycophenolate mofetil, etc) or UVA1 phototherapy \<2 months prior to enrollment.
• Prior failed UVA1 phototherapy (defined as requiring initiation of systemic therapy during or within 1 month of completion of prior course of UVA1 phototherapy).
• Presence of the following related to diagnosis of morphea: systemic manifestations (arthritis, uveitis, CNS changes, and the like), limited range of motion, contracture, limb length discrepancy requiring oral systemic therapy.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center - Department of Dermatology

Dallas, Texas, 75390-9069, United States

Location

Related Links

• UTSW UVA-1 Phototherapy Clinical Trial for Morphea

MeSH Terms

Conditions

Scleroderma, Localized

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Heidi Jacobe, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 26, 2013
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: September 13, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)