A Clinical Study of Tranilast in the Treatment of Mucinoses

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03490708

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mucinoses	Drug: Tranilast	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Clinical Study of Tranilast in the Treatment of Mucinoses

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranilast Subjects who were treated with tranilast	Drug: Tranilast Subjects will be treated with tranilast

Arm

Intervention/Treatment

Experimental: Tranilast

Subjects who were treated with tranilast

Drug: Tranilast

Subjects will be treated with tranilast

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical and histopathological examination has been proved to be Mucinoses;
Ultrasound and magnetic resonance detection found that the skin was thickened.

Exclusion Criteria:

With a liver or kidney disease, or accompanied by a severe infection;
Poor control of primary disease;
With mental disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT03490708

Other Study ID Numbers:

Mucinoses MH Hou

First Posted:

Apr 6, 2018

Last Update Posted:

Apr 6, 2018

Last Verified:

Feb 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The First Affiliated Hospital with Nanjing Medical University

Mucinoses

Tranilast

Additional relevant MeSH terms:

Mucinoses

Tranilast

Study Results

No Results Posted as of Apr 6, 2018