MorpheaEarly Phase 1NCT02411643
Molecular Effects of Topical Calcipotriene on Morphea
A Early Phase 1 study testing topical calcipotriene 0.005% ointment in people with Morphea and Localized Scleroderma, run by Northwestern University at 1 site in United States.
Trial summary
This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morphea, Localized Scleroderma
- What is being tested?
- topical calcipotriene 0.005% ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2016
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
- Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
- Age ≥ 18 years.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
- Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
- Subjects may not be receiving any investigational agents.
- Subjects must not be pregnant or nursing.
- Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.
- Conditions
- Morphea, Localized Scleroderma
- Being tested
- topical calcipotriene 0.005% ointment
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical calcipotriene 0.005% ointmentDrug
Also called Dovonex
Affected area will be treated twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| topical calcipotriene 0.005% ointment | Other | Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects Receives: Drug: topical calcipotriene 0.005% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Gene Expression From Skin Biopsy
Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels
Measured: day 0 and 3 months
Secondary outcomes (3)
Quality of Life
Quality of life questions will be asked at day 0 and 3 months
Measured: day 0 and 3 months
Modified Localized Scleroderma Skin Score
The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months
Measured: day 0 and 3 months
Change of Appearance of Skin Biopsy
Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins
Measured: day 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Accrual incomplete/Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MorpheaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Graham, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411643
- Sponsor's protocol ID
- STU00101294
- Status last verified
- Dec 2017
- First submitted
- 3 Mar 2015
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Effects of Topical Calcipotriene on Morphea
- ClinicalTrials.gov ID
- NCT02411643
- Acronym / sponsor ID
- STU00101294
- Conditions
- Morphea, Localized Scleroderma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual incomplete/Investigator left institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| topical calcipotriene 0.005% ointment | Other | Drug: topical calcipotriene 0.005% ointmentCalcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
- Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
- Age ≥ 18 years.
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (5 listed)
- Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
- Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
- Subjects may not be receiving any investigational agents.
- Subjects must not be pregnant or nursing.
- Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.
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 |
|---|---|---|
| topical calcipotriene 0.005% ointmentAlso: DovonexAffected area will be treated twice daily for 3 months | Drug | topical calcipotriene 0.005% ointment |
Primary outcome
Change of Gene Expression From Skin Biopsy
Time frame: day 0 and 3 months
Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels
3 secondary outcomes
Quality of Life
Time frame: day 0 and 3 months
Modified Localized Scleroderma Skin Score
Time frame: day 0 and 3 months
Change of Appearance of Skin Biopsy
Time frame: day 0 and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Morphea
Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
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Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
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RecruitingObservational study
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
Scleroderma, Localized, Morphea
Enrolling by invitationObservational study
Elastography Ultrasound in Localized Scleroderma (Morphea) Study
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Recruiting
Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing topical calcipotriene 0.005% ointment in people with Morphea and Localized Scleroderma, run by Northwestern University 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Sep 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Gene Expression From Skin Biopsy (time frame: day 0 and 3 months). 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 13 Sep 2018.