A Clinical Study of Tranilast in the Treatment of Mucinoses

Nanjing Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Mucinoses

Treatments: Drug: Tranilast

Study type: Interventional

Funder types: Other

Identifiers

NCT03490708

Mucinoses MH Hou

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Tranilast

Experimental group

Description:

Subjects who were treated with tranilast

Treatment:

Drug: Tranilast