A Clinical Study of Tranilast in the Treatment of Mucinoses

Early Phase 1

• Conditions: Mucinoses
• Interventions: Drug: Tranilast

• Registration Number: NCT03490708
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-04
• Study Start: 2018-04
• Study First Submitted QC: 2018-04-01
• Last Update Submitted: 2018-04-01
• Study First Posted: 2018-04-06
• Last Update Posted: 2018-04-06
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranilast	Tranilast	Subjects who were treated with tranilast

Primary Outcome Measures

Name	Time	Method
Measure the volume change of skin lesions by ultrasound	This experiment will last for 12 months	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