A Clinical Study of Tranilast in the Treatment of Mucinoses

Mucinoses Clinical Trial

Official title:

A Clinical Study of Tranilast in the Treatment of Mucinoses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03490708
• Other study ID #: Mucinoses MH Hou
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: February 4, 2018
• Last updated: April 1, 2018
• Start date: April 2018
• Est. completion date: December 2022

Study information

• Verified date: February 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

56 participants with Mucinoses will be selected to receive treatment of tranilast. After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.

Description:

56 participants with Mucinoses will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos,the thickness and area of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast (0.1g each time, three times a day,12 months) treatment, participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness and area. With 3 month as a time point, participants were observed for four points. After the experiment, the experimental data will be arranged and the data of the thickness and area change of skin lesions will be statistically processed to determine whether it is meaningful.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical and histopathological examination has been proved to be Mucinoses;

2. Ultrasound and magnetic resonance detection found that the skin was thickened.

Exclusion Criteria:

1. With a liver or kidney disease, or accompanied by a severe infection;

2. Poor control of primary disease;

3. With mental disease.

Related Conditions & MeSH terms

• Mucinoses

Intervention

Drug:
• Tranilast
Subjects will be treated with tranilast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the volume change of skin lesions by ultrasound	During tranilast (0.1g each time, three times a day, 12 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective	This experiment will last for 12 months