Assessment of the botulinum toxin type A effect on Intensified Raynauds Phenomenon in Sclerodermic patients
Phase 2
- Conditions
- Systemic sclerosis [scleroderma].Systemic sclerosis [scleroderma]
- Registration Number
- IRCT20200106046023N1
- Lead Sponsor
- Oroumia University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
Patients with scleroderma based on ACR criteria
Patients with Age over 18 years
Intensified and Resistant Raynauds
Exclusion Criteria
A history of allergy to Botox
History of myasthenia gravis disease
Pregnancy and lactation
Taking estrogen-containing pills in the last month
History of vascular surgery and sympathectomy
Consumption of Aminoglycoside Antibiotics
The presence of active infection
The presence of severe bleeding tendency
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Raynauds activity. Timepoint: Before intervention; one and two months after injection of botulinum toxin A. Method of measurement: The Reynolds Activity Score will be measured using a standard questionnaire consisting of 4 subsets, each rated 0-4 score.;Number of new wounds. Timepoint: Before intervention; one and two months after injection of botulinum toxin A. Method of measurement: The number of new wounds in the fingers will be counted by clinical examination.
- Secondary Outcome Measures
Name Time Method The number of fingers wounds. Timepoint: Before intervention, one and two months after injection of botulinum toxin A. Method of measurement: The number of wounds in the fingers will be counted by clinical examination.;Pain. Timepoint: Before intervention, one and two months after injection of botulinum toxin A. Method of measurement: Visual Analogue Scale.