Evaluation of efficacy and safety of collagenase enzyme in the treatment of cutaneous sclerosis in patients with systemic scleroderma.
Design
Clinical trial, randomized, Phase 2, non-blinded
Settings and conduct
This study was performed on 17 scleroderma patients referred to Hazrat Rasoul Hospital.The amount of facial wrinkles (opening mouse), scleroderma lesions of the face and around the lips and necrotic lesions of the fingers are examined. The blinding rule is not used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients should have at least one active scleroderma lesion.
2. Patients 20 to 70 years old.
Exclusion criteria:
1-Patients who have received or inhaled oral prostanoids in the past 3 months. 2- Phosphodiesterase inhibitors have been used in the past month.
3- Take antibiotics 2 weeks before the study
4- Patients with common diseases such as diabetes, thyroid, cardiovascular complications such as ischemic heart disease.
Intervention groups
The intervention group is patients suffering from scleroderma lesions and receiving collagenase ointment as interferer, twice a day for three months. This study is a pilot study and before and after the patient is in control.
Main outcome variables
Qualitative and quantitative intensity of scleroderma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140624018210N11
Registration date:2021-12-12, 1400/09/21
Registration timing:prospective
Last update:2021-12-12, 1400/09/21
Update count:0
Registration date
2021-12-12, 1400/09/21
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-04-17, 1401/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of collagenase enzyme in the treatment of cutaneous sclerosis in patients with systemic scleroderma
Public title
effect of collagenase enzyme in scleroderma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should have at least one active scleroderma lesion
Exclusion criteria:
Patients who have received or inhaled oral prostanoids in the past 3 months.
Phosphodiesterase inhibitors have been used in the past month.
Take antibiotics 2 weeks before the study.
Age
From 20 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
17
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran university -Hemat Highway
City
Tehran
Province
Tehran
Postal code
19922347512
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.IUMS.FMD.REC.1400.501
Health conditions studied
1
Description of health condition studied
systemic scleroderma
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]
Primary outcomes
1
Description
Qualitative intensity of scleroderma
Timepoint
Before treatment and 3 months after treatment
Method of measurement
Patient complaint, objective evaluation by a physician.
Secondary outcomes
1
Description
Quantitative intensity of scleroderma
Timepoint
Before treatment, three months after treatment
Method of measurement
Determine the size of the lesions with visioface, determine the location and number of lesions
Intervention group: The intervention group is patients suffering from scleroderma. The intervention group will use collagenase ointment topically, twice a day for three months without interruption. It should be noted that the patient will receive routine treatments for this disease and will not be deprived of routine treatments.