Molecular Effects of Topical Calcipotriene on Morphea
| Status: | Terminated |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2018 |
| Start Date: | March 2015 |
| End Date: | April 2016 |
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Lauren V Graham, MD, PhD
Phone: 312-695-6829
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