Localized Scleroderma, Morphea
Conditions
Brief 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. 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.
Interventions
DRUGtopical calcipotriene 0.005% ointment
Affected area will be treated twice daily for 3 months
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Gene Expression From Skin Biopsy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | day 0 and 3 months | Quality of life questions will be asked at day 0 and 3 months |
| Modified Localized Scleroderma Skin Score | day 0 and 3 months | The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months |
| Change of Appearance of Skin Biopsy | day 0 and 3 months | Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Calcipotriene 0.005% Ointment Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects
topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Topical Calcipotriene 0.005% Ointment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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
Time frame: day 0 and 3 months
Population: Study was terminated prior to obtaining results.
Secondary
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
Time frame: day 0 and 3 months
Population: Study was terminated before results were obtained.
Secondary
Modified Localized Scleroderma Skin Score
The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months
Time frame: day 0 and 3 months
Population: Study was terminated before results were obtained.
Secondary
Quality of Life
Quality of life questions will be asked at day 0 and 3 months
Time frame: day 0 and 3 months
Population: Study was terminated prior to obtaining results.