Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 6 - 95 |
| Updated: | 4/2/2016 |
| Start Date: | May 2012 |
| Contact: | Heidi Jacobe, MD, MSCS |
| Email: | heidi.jacobe@utsouthwestern.edu |
| Phone: | 214.633.1837 |
Something New Under the Sun: A Randomized, Double-Blinded, Controlled Trial of UVA1 Phototherapy in 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.
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.
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.
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