Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
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.
Procedure: UVA-1 Phototherapy
|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|
- 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.
- 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.
|Study Start Date:||May 2012|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799174
|Contact: Heidi Jacobe, MD, MSCSfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Heidi Jacobe, MD, MSCS|