Evaluating the effect of tropical sildenafil gel on incidence and severity of Raynaud’s Phenomenon Attacks in patients with systemic sclerosis: A double blinded randomized clinical trial

Determining the effect of topical sildenafil gel on the occurrence of Raynaud's phenomenon and severity of symptoms in patients with systemic scleroderma(SS) in a double-blind clinical trial study.

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Sealed cards are used in the randomization method.

Patients with SS with skin involvement referring to Shahrekord rheumatology clinic are included in the study. Before entering the study, the patients will be visited once and their pain intensity and quality of life will be evaluated. They will also undergo nailfold capiloroscopy. This study will be done in a double-blind manner; In this way, first, all gels (sildenafil and placebo) will be coded by the clinical pharmacist and will be delivered to the researcher following the patient. Each patient will be followed up with a code that the content of the medicine he received will not be known until the end of the study. After two weeks have passed They will be visited again and evaluated in terms of pain intensity, quality of life and NF.

People diagnosed with SS according to the American College of Rheumatology classification criteria or LeRoy and Medsger criteria and skin involvement limited to fingers, hands, face, forearms and foot.

Patients in both groups (Sildenafil 1% and placebo) will be used topically every 12 hours. The length of the treatment period for each patient is 14 days and it will end if the patient recovers completely and reaches the end point of the treatment. It should be noted that the routine treatment of patients in both groups will be the same and will be based on the latest relevant guidelines.

Pain intensity, quality of life and nailfold capiloroscopy

By simple randomization, an envelope with a hidden card (35 group 1 and 35 group 2) will be selected for each person eligible to enter the study, and each patient will be assigned to the intervention or placebo group. Only the statistician and the clinical pharmacist will know the contents of each card and medicine received, and the shape, smell, color and other physical properties of the placebo will be similar to the medicine received by the intervention group.

This study will be done in a double-blind manner; In this way, first, all gels (sildenafil and placebo, which are completely similar in terms of shape, color, smell, and consistency) will be coded by the clinical pharmacist and will be delivered to the researcher following the patient based on the block in which the patient is located. . Each patient will be followed up with a code that is not known about the content of the medicine he received until the end of the study.

To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published

The access period will start 6 months after the results are published

Our data will only be available to researchers working in academic and scientific institutions .

If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.

In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address alireza_rostamian@yahoo.com or the contact number 00989356824034

To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.