Back to resultsTreatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
Primary Purpose
Scleroderma, Localized, Morphea, Scleroderma, Circumscribed
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UVA-1 Phototherapy
Placebo
Sponsored by
About this trial
This is an interventional other trial for Scleroderma, Localized
Eligibility 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.
Sites / Locations
- UT Southwestern Medical Center - Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
UVA-1 Phototherapy
Placebo
Arm Description
Receive medium dose UVA-1 (70 J/cm2) 3x/week for 10 weeks
Receive "sham" UVA1 phototherapy (0 J/cm2) 3x/week for 10 weeks
Outcomes
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)
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.
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.
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.
Full Information
NCT ID
NCT01799174
First Posted
February 22, 2013
Last Updated
September 24, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01799174
Brief Title
Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
Official Title
Something New Under the Sun: A Randomized, Double-Blinded, Controlled Trial of UVA1 Phototherapy in Morphea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Localized, Morphea, Scleroderma, Circumscribed
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UVA-1 Phototherapy
Arm Type
Active Comparator
Arm Description
Receive medium dose UVA-1 (70 J/cm2) 3x/week for 10 weeks
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Receive "sham" UVA1 phototherapy (0 J/cm2) 3x/week for 10 weeks
Intervention Type
Procedure
Intervention Name(s)
UVA-1 Phototherapy
Intervention Type
Procedure
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To determine the effect of UVA1 phototherapy in patients with morphea using a validated clinical outcome measure, the Localized Scleroderma Severity Index (LoSSI)
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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.
Description
PGA-A has been validated for content validity, reliability, and sensitivity to change. This will serve as a secondary outcome.
Time Frame
3 years
Title
To use gene expression profiling to characterize pathways and mechanisms that are involved in the therapeutic effect of UVA1 phototherapy.
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Jacobe, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center - Department of Dermatology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9069
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.utsouthwestern.edu/education/medical-school/departments/dermatology/research/uva-phototherapy/index.html
Description
UTSW UVA-1 Phototherapy Clinical Trial for Morphea
Learn more about this trial
Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
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