Status:
COMPLETED
Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Scleroderma, Localized
Morphea
Eligibility:
All Genders
6-95 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01799174
Start Date
May 1 2012
End Date
September 13 2019
Last Update
September 25 2019
Active Locations (1)
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1
UT Southwestern Medical Center - Department of Dermatology
Dallas, Texas, United States, 75390-9069