Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings

Laboratoires Innothera1 site in 1 country3 target enrollmentNovember 2011

ConditionsSkin Lesions

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Skin Lesions
Sponsor: Laboratoires Innothera
Enrollment: 3
Locations: 1
Primary Endpoint: nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.

Detailed Description

To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratoires Innothera

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
•Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
•Subjects for whom the incriminated stockings provide class 2 compression or higher.
•Subjects covered by French national health insurance.
•Subjects who give their written informed consent and who accept the constraints of the study.

Exclusion Criteria

•Known allergy to local anesthetics (lidocaine, etc.).
•History of anaphylactic shock.
•Ongoing antihistamine treatment or having taken during the week before inclusion.
•Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
•Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
•Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back).
•Patient having concomitantly used compression stockings and a topical corticosteroid on the thighs in the 48 hours preceding lesion onset.
•List of diseases which will prevent a subject from participating in the study:
•acquired, infectious or drug-induced congenital immunosuppression (systemic corticosteroid therapy, immunosuppressives, chemotherapy),
•Congenital bullous disorder (congenital epidermolysis bullosa) or acquired bullous disorder (pemphigus, pemphigoid, dermatitis herpetiformis, linear IgA dermatosis, etc.).