Symmetric Limited MorpheaNCT00812188
Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.
A study testing Medium Dose UVA-1 and High Dose UVA-1 in people with Symmetric Limited Morphea, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Symmetric Limited Morphea
- What is being tested?
- Medium Dose UVA-1 and High Dose UVA-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2009
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 years of age or older.
- Symmetric limited morphea.
Who cannot join
- Known sensitivity to fluocinonide 0.05% cream.
- Clinical evidence of superinfected skin.
- Immunocompromised state (including previously documented HIV).
- Generalized Scleroderma.
- Previous history of skin cancer.
- Non-English speaking subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas - Department of Dermatology Clinical Trials
Dallas, Texas, 75390
About this study
Official title: A Prospective, Open Label Trial of High Dose UVA-1, 3x/Week or Medium Dose UVA-1, 3x/Week vs. Fluocinonide 0.05% Cream Treatment of Morphea
Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.
- Conditions
- Symmetric Limited Morphea
- Being tested
- Medium Dose UVA-1, High Dose UVA-1
- Keywords
- Morphea, Plaque morphea, Localized Scleroderma
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Dose UVA-1Other
UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.
High Dose UVA-1Other
High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Medium Dose UVA-1 | Active comparator | Medium dose (60 J/cm2) UVA-1 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream to another morphea plaque twice daily for twelve weeks. Receives: Other: Medium Dose UVA-1 |
| High Dose UVA-1 | Active comparator | High dose UVA-1 treatment 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream twice daily for 12 weeks to another morphea plaque. Receives: Other: High Dose UVA-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of UVA-1 treatment vs. topical steroid.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startNov 2004
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symmetric Limited MorpheaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Jacobe, University of Texas Southwestern Medical Center
- Investigators
- Heidi Jacobe, M.D., Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812188
- Sponsor's protocol ID
- 112004027
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2008
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Trial of High Dose UVA-1, 3x/Week or Medium Dose UVA-1, 3x/Week vs. Fluocinonide 0.05% Cream Treatment of Morphea
- ClinicalTrials.gov ID
- NCT00812188
- Acronym / sponsor ID
- 112004027
- Conditions
- Symmetric Limited Morphea
- Keywords
- Morphea, Plaque morphea, Localized Scleroderma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Dec 2008 (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.
Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium Dose UVA-1 | Active comparator | Other: Medium Dose UVA-1Medium dose (60 J/cm2) UVA-1 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream to another morphea plaque twice daily for twelve weeks. |
| High Dose UVA-1 | Active comparator | Other: High Dose UVA-1High dose UVA-1 treatment 3x/week for 12 weeks to one morphea plaque and fluocinonide 0.05% cream twice daily for 12 weeks to another morphea plaque. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects 18 years of age or older.
- Symmetric limited morphea.
Key exclusion criteria (6 listed)
- Known sensitivity to fluocinonide 0.05% cream.
- Clinical evidence of superinfected skin.
- Immunocompromised state (including previously documented HIV).
- Generalized Scleroderma.
- Previous history of skin cancer.
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 |
|---|---|---|
| Medium Dose UVA-1UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks. | Other | Medium Dose UVA-1 |
| High Dose UVA-1High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks. | Other | High Dose UVA-1 |
Primary outcome
Efficacy of UVA-1 treatment vs. topical steroid.
Time frame: 5 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 18 Feb 2019.
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, M.D. principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium Dose UVA-1 and High Dose UVA-1 in people with Symmetric Limited 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 2 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 18 Feb 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. 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?
Efficacy of UVA-1 treatment vs. topical steroid. (time frame: 5 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 18 Feb 2019.