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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01799174
First received: February 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Scleroderma, Localized
Morphea
Scleroderma, Circumscribed
Procedure: UVA-1 Phototherapy
Procedure: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Something New Under the Sun: A Randomized, Double-Blinded, Controlled Trial of UVA1 Phototherapy in Morphea

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To determine the effect of UVA1 phototherapy in patients with morphea using a validated clinical outcome measure, the Localized Scleroderma Severity Index (LoSSI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    PGA-A has been validated for content validity, reliability, and sensitivity to change. This will serve as a secondary outcome.

  • To use gene expression profiling to characterize pathways and mechanisms that are involved in the therapeutic effect of UVA1 phototherapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The molecular mechanisms underlying the efficacy of UVA1 phototherapy in morphea are incompletely understood. To identify UVA1-induced molecular pathways that may account for its efficacy, we will perform gene expression profiling using RNA derived from affected and nonlesional whole skin from patients with morphea before and after UVA1 phototherapy.


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UVA-1 Phototherapy
Receive medium dose UVA-1 (70 J/cm2) 3x/week for 10 weeks
Procedure: UVA-1 Phototherapy
Sham Comparator: Placebo
Receive "sham" UVA1 phototherapy (0 J/cm2) 3x/week for 10 weeks
Procedure: Placebo

  Eligibility

Ages Eligible for Study:   6 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799174

Contacts
Contact: Heidi Jacobe, MD, MSCS 214.633.1837 heidi.jacobe@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center - Department of Dermatology Recruiting
Dallas, Texas, United States, 75390-9069
Contact: Heidi Jacobe, MD, MSCS    214-633-1837    heidi.jacobe@utsouthwestern.edu   
Principal Investigator: Heidi Jacobe, MD, MSCS         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01799174     History of Changes
Other Study ID Numbers: 022012025
Study First Received: February 22, 2013
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Localized
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014