Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea
Design
This is a Phase 3 clinical trial study of randomized controlled and no blinding with parallel groups. Patients with active localized morphea with a maximum size of 10 cm2 in 20 individuals who were randomly assigned to two groups of 10 using Rand List software 1: Fluocinolone treatment with topical tacrolimus 2: Fluocinolone treatment with NBUVB Will take.
Settings and conduct
In this study, 20 patients with active localized morphea who referred to Sina Hospital's dermatology clinic were randomly assigned to two groups of 10 interventions (fluocinolone ointment with topical tacrolimus) and control (fluocinolone ointment with NBUVB).
Participants/Inclusion and exclusion criteria
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 10 cm2
• Do not use immunosuppressants or phototherapy in the last three months
Non-entry criteria:
Systemic sclerosis or pseudosclerosis
- Existence of a history of side effects in previous use of tacrolimus (hypersensitivity, intolerance)
- Having radiotherapy contraindications
Pregnant women or those who are planning to become pregnant during treatment
- Breastfeeding women
Intervention groups
Intervention group: receiving topical fluocinolone ointment with topical tacrolimus. In the intervention group of 10 patients with localized morphea, topical fluocinolone ointment with topical tacrolimus will be given every 12 hours for 4 months. In the control group of 10 patients with localized morphea, fluocinolone ointment will be given every 12 hours and NBUVB 3 times a week for 4 months.
Main outcome variables
Waste area; Dispigmentation; Stiffness; Atrophic extent of lesions and patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002581N7
Registration date:2020-09-05, 1399/06/15
Registration timing:registered_while_recruiting
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea
Public title
Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea
Purpose
Treatment
Inclusion/Exclusion criteria
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)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Approval date
2020-07-20, 1399/04/30
Ethics committee reference number
IR.TBZMED.REC.1399.401
Health conditions studied
1
Description of health condition studied
Localized morphea
ICD-10 code
L94.0
ICD-10 code description
Localized scleroderma [morphea]
Primary outcomes
1
Description
Morphea waste area
Timepoint
Months 0 -2- 4
Method of measurement
Measurement with ruler
2
Description
Dispigmentation
Timepoint
Months 0 -2- 4
Method of measurement
16 megapixel digital camera from a distance of 10 cm from the lesion
3
Description
Hardness
Timepoint
Months 0 -2- 4
Method of measurement
Observe and pinch through the lesion
4
Description
Atrophy
Timepoint
Months 0 -2- 4
Method of measurement
View and touch as well as digital camera
Secondary outcomes
1
Description
Patient satisfaction after treatment
Timepoint
Months 0- 2- 4
Method of measurement
Patient serial examination - questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Hamideh Herizchi
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Fax
+98 41 8406 3549
Email
Drherizchi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ataa Mahmoudpour
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamide Herizchi Ghadim
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamide Herizchi Ghadim
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Forough Yadegari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
f.yadegari8766@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after being unidentified.
When the data will become available and for how long
All any time
To whom data/document is available
It will be free for every one.
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Email: Drherizchi@yahoo.com, 09141168780, Dr Hamide Herizchi Ghadim, Dermatology Department - Sina Hospital - Azadi sreet - Tabriz.
What processes are involved for a request to access data/document
The request will be checked, then data will be sent by Email in 1 month.