Something New Under the Sun: A Randomized, Double-Blinded, Controlled Trial of UVA1 Phototherapy in Morphea

Study ID
STU 022012-025

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Noelle Teske
801/556-6604
noelle.teske@utsouthwestern.edu

Principal Investigator
Heidi Jacobe

Summary

This is a randomized, blinded, and controlled trial (RBCT) 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 [Quote]sham[Quote] uVa1 (0 J/cm2) phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The phototherapists, patients, and principle 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 RBCT will be followed during an open observation period for 3 months. During the open phase, all outcome measures from the RBCT will be assessed every 6 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 RBCT during the open observation. adult patients enrolled in the RBCT 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.

Participant Eligibility


* 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).