scleroderma. Systemic sclerosis [scleroderma]
Conditions
Interventions
Intervention 1: Intervention group: A solution of 200 units of hyaluronidase in 6 mL of normal saline will be injected subcutaneously in two concentric rows of 1 cm-spaced aliquots around the vermilio
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Diagnosis of systemic sclerosis with moderate to severe reduced oral aperture diagnosed and confirmed by 2 board certified rheumatologists Willingness to participate in the study
Exclusion criteria
Exclusion criteria: History of adverse reactions to Hyaluronidase Unwillingness to comply with study requirements Patients with a change to immunosuppressive therapy within 3 months or during treatment were excluded Known history of hypersensitivity to any components in the formulation Active skin infection at the proposed injection site Patients who were pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mouth Opening Capacity (MOC) refers to the maximum vertical distance between the upper and lower lips when the mouth is fully opened. This metric indicates the ability of patients with systemic sclerosis to open their mouths and is one of the primary evaluation criteria in this study. Timepoint: Measurements are taken before the treatment and during follow-up sessions, specifically at 2 weeks and 3 months after the injections. Method of measurement: MOC is measured using a precise ruler, and the distance is recorded in centimeters.;The Mouth Handicap in Systemic Sclerosis (MHISS) score assesses the level of oral impairment caused by systemic sclerosis. It is measured using a 12-item questionnaire with a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score can reach up to 48, reflecting the degree of impact the disease has on the patient’s oral function. Timepoint: Measurements are taken before the treatment and during follow-up sessions, specifically at 2 weeks and 3 months after the injections. Method of measurement: The questionnaire is completed by the patients at specific times, and their scores are recorded. These scores will be calculated and documented before the start of treatment, 2 weeks, and 3 months after the injections to assess the changes in scores over the course of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to initial symptomatic improvement refers to the time required to observe the first signs of improvement in mouth opening or reduction in oral impairment. This metric reflects the speed of patient response to the treatment. Timepoint: The question is asked during the follow-up sessions, specifically at 2 weeks and 3 months after the injections. Method of measurement: This duration is calculated from the day treatment starts until the first follow-up session when the patient reports symptomatic improvement, recorded in days.;The incidence of adverse events includes any unintended reactions experienced by patients during injections. This outcome is assessed to evaluate the safety and tolerability of the treatments. Timepoint: The question is asked during the follow-up sessions, specifically at 2 weeks and 3 months after the injections. Method of measurement: eported adverse events are recorded during follow-up sessions. The type, severity, and duration of each adverse event are documented.;The duration until stabilization of improvement indicates the time it takes for the patient to reach a stable level of symptomatic improvement. This outcome is crucial, as some patients may experience rapid initial improvement that may not be sustained. Timepoint: The question is asked during the follow-up sessions, specifically at 2 weeks and 3 months after the injections. Method of measurement: This duration is recorded in days from the beginning of treatment until the symptoms reach a stable level with no significant fluctuations. Stability is confirmed through repeated measurements at follow-up sessions.;Patient satisfaction reflects the overall level of satisfaction and experience that patients have regarding the effectiveness of the treatments. This metric indicates the degree of acceptance and perceived improvement by patients after receiving injections. Timepoint: It is measured during the follow-up sessions, specifically at 2 weeks and 3 months after the injections | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShirin Zaresharifi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed