]>
IRCT20091012002581N7 IRCT 2020-09-05 Tabriz University of Medical Sciences Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea 2020-04-20 anticipated 20 Complete https://irct.ir/trial/46993 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization will be carried out on an individual basis by Rand List software.The allocation will be seated by an independent monitor and will not be broken until the end of the study. 3 Localized morphea. Intervention 1: Intervention group: 10 people with localized morphea will be treated with topical ointment fluocinolone and tacrolimus 0.1 percent every 12 hours for 4 months. Intervention 2: Control group: 10 people with localized morphea treated with topical fluocinolone ointment every 12 hours with phototherapy with NBUVB will be given three sessions a week for 4 months. Yes - There is a plan to make this available What will be shared: All data will be shared after being unidentified. When: All any time To whom: It will be free for every one. Conditions: There are no special conditions. Where to obtain: Email: Drherizchi@yahoo.com, 09141168780, Dr Hamide Herizchi Ghadim, Dermatology Department - Sina Hospital - Azadi sreet - Tabriz. How to obtain: The request will be checked, then data will be sent by Email in 1 month. Comments:
public Dr Hamide Herizchi Ghadim
Azadi Street
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 8236 3549 Drherizchi@yahoo.com Tabriz University of Medical Sciences scientific Dr Hamide Herizchi Ghadim
Azadi Street
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 8236 3549 Drherizchi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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) L94.0 Localized scleroderma [morphea] Treatment - Other Treatment - Other Intervention group: 10 people with localized morphea will be treated with topical ointment fluocinolone and tacrolimus 0.1 percent every 12 hours for 4 months. Control group: 10 people with localized morphea treated with topical fluocinolone ointment every 12 hours with phototherapy with NBUVB will be given three sessions a week for 4 months. 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. Patient satisfaction after treatment. Timepoint: Months 0- 2- 4. Method of measurement: Patient serial examination - questionnaire. Tabriz University of Medical Sciences Approved 2020-07-20 Ethics committee of Tabriz University of Medical Sciences Daneshgah Tabriz East Azarbaijan Iran (Islamic Republic of)