Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea
Phase 3
Recruiting
- Conditions
- ocalized morphea.Localized scleroderma [morphea]L94.0
- Registration Number
- IRCT20091012002581N7
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
The disease is in its active phase
Patients have not received any treatment in the past 6 weeks
Existence of at least one morphea plaque with a total area of cm2 10
Lack of use of immunosuppressants, penicillamine, interferon gamma, or phototherapy in the last three months
Exclusion Criteria
Systemic sclerosis or pseudosclerosis
Existence of a history of side effects in previous use of tacrolimus (hypersensitivity, intolerance)
Contraceptive radiation therapy
Pregnant women or those who are planning to become pregnant during treatment
Breastfeeding women
Infectious active lesion at the site of morphea plaque
Recent vaccinations (28 days before the start of the study)
Borrelia burgdorferi infection (serological diagnosis)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morphea waste area. Timepoint: Months 0 -2- 4. Method of measurement: Measurement with ruler.;Dispigmentation. Timepoint: Months 0 -2- 4. Method of measurement: 16 megapixel digital camera from a distance of 10 cm from the lesion.;Hardness. Timepoint: Months 0 -2- 4. Method of measurement: Observe and pinch through the lesion.;Atrophy. Timepoint: Months 0 -2- 4. Method of measurement: View and touch as well as digital camera.
- Secondary Outcome Measures
Name Time Method Patient satisfaction after treatment. Timepoint: Months 0- 2- 4. Method of measurement: Patient serial examination - questionnaire.