Scleroderma, LocalizedNCT01799174
Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
A study testing UVA-1 Phototherapy in people with Scleroderma, Localized and Morphea, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 95 years
- Conditions the study is for
- Scleroderma, Localized, Morphea, Scleroderma, Circumscribed
- What is being tested?
- UVA-1 Phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 13 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center - Department of Dermatology
Dallas, Texas, 75390-9069
About this study
Official title: 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.
- Conditions
- Scleroderma, Localized, Morphea, Scleroderma, Circumscribed
- Being tested
- UVA-1 Phototherapy, Placebo
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVA-1 PhototherapyProcedure or surgery
PlaceboProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| UVA-1 Phototherapy | Active comparator | Receive medium dose UVA-1 (70 J/cm2) 3x/week for 10 weeks Receives: Procedure: UVA-1 Phototherapy |
| Placebo | Sham comparator | Receive "sham" UVA1 phototherapy (0 J/cm2) 3x/week for 10 weeks Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, LocalizedStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Jacobe, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799174
- Sponsor's protocol ID
- 022012025
- Status last verified
- Sep 2019
- First submitted
- 22 Feb 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Something New Under the Sun: A Randomized, Double-Blinded, Controlled Trial of UVA1 Phototherapy in Morphea
- ClinicalTrials.gov ID
- NCT01799174
- Acronym / sponsor ID
- 022012025
- Conditions
- Scleroderma, Localized, Morphea, Scleroderma, Circumscribed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVA-1 Phototherapy | Active comparator | Procedure: UVA-1 PhototherapyReceive medium dose UVA-1 (70 J/cm2) 3x/week for 10 weeks |
| Placebo | Sham comparator | Procedure: PlaceboReceive "sham" UVA1 phototherapy (0 J/cm2) 3x/week for 10 weeks |
Who may qualify
- Ages
- 6 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVA-1 Phototherapy | Procedure or surgery | UVA-1 Phototherapy |
| Placebo | Procedure or surgery | Placebo |
Primary outcome
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
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.
2 secondary outcomes
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
To use gene expression profiling to characterize pathways and mechanisms that are involved in the therapeutic effect of UVA1 phototherapy.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- UTSW UVA-1 Phototherapy Clinical Trial for MorpheaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Jacobe, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVA-1 Phototherapy in people with Scleroderma, Localized and Morphea, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.