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Polidocanol for use as immunomodulating agent

A technology for polidocanol and immune regulation, which is applied in the field of immune and inflammatory response regulators, and can solve problems such as unproven useful effects of polidocanol, improvement of skin nutrition, and undisclosed polidocanol.

Pending Publication Date: 2021-01-29
保罗卡索尼
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] To the applicant's knowledge, the useful effect of polidocanol concentrations below 0.25% has never been demonstrated, nor has the use of polidocanol been disclosed to improve skin nutrition, hair appearance or improve its immunomodulatory effects

Method used

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  • Polidocanol for use as immunomodulating agent
  • Polidocanol for use as immunomodulating agent
  • Polidocanol for use as immunomodulating agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1. Functional injection therapy (FIT) with diluted polidocanol.

[0054] commercially available polidocanol solution with normal saline solution Dilute to 0.05%. Then 1.4% sodium bicarbonate solution was added to obtain a final concentration of 0.06%. Eighty percent of the patients were women between the ages of 18 and 82 with mild to severe venous insufficiency who were treated with their free and informed consent.

[0055] Prior to treatment, approximately 100 patients were surveyed to assess their quality of life and to assess possible changes in inflammatory / inflammatory general status, venous microcirculation and circulatory function, and also more generally skin nutrition.

Embodiment 2

[0057] Example 2. Evaluation of long-term systemic effects of diluted polidocanol: QoL investigation.

[0058] Long-term systemic effects were assessed by surveys administered to patients after 3 or 4 treatments with diluted polidocanol.

[0059] In particular, they were required to be based on the definition in Launois R. et al., "Construction and validation of aquality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ), Qual. Life Res., 1996, 5(6):539-554 Standard fill out questionnaire (CIVIQ-20).

[0060] The questionnaire contained the questions outlined below, with answers indexed from 0 to 4 (0 if the discomfort described by the question was not applicable, and 1 to 4 if increasing levels of intensity were applicable). Below is a collection of activities that were found to improve after treatment:

[0061] 1) In the past 4 weeks, have you had hip or leg pain and to what extent? In 14% of cases a reduction in hip pain was observed after treatment...

Embodiment 3

[0084] Example 3. Likert Questionnaire Regarding the "Inflammation" Status of Treated Subjects

[0085] To the question on quality of life, 10 more specific questions were added to assess possible changes in "inflammatory" status (n=100 patients) after treatment. The survey was based on the indications of: "Evaluation by Likert-type scale 4-point (0-absent, 1-moderate, 2-severe and 3-very severe)" Elleuch et al., Adv Ther .2016Sep;33(9):1536-49.Subjects were asked to conduct a self-assessment after each treatment and to evaluate the survey results after 8 to 10 months (ie, after at least 4 to 5 treatments).

[0086] The survey was customized on a Likert scale and aimed to evaluate a number of symptoms associated with chronic inflammation, such as joint or arthritic manifestations (general and autoimmune sex), which specifically involves joint mobility and pain.

[0087] Answers are indexed on a scale from 0 to 3 (or 0 to 2).

[0088] 1. Joint Mobility

[0089] ...

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PUM

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Abstract

The present invention relates to the use of diluted, thus non-sclerosing, polidocanol solutions as immunomodulating and anti-inflammatory agents. The inventions further relates to non-sclerosing compositions 5 comprising polidocanol in concentration of from 0.03 to 0.10% w / V for the treatment of psoriatic skin rashes, for cosmetic use and for the reduction of peripheral venous stasis.

Description

[0001] field of invention [0002] The present invention relates to the use of diluted polidocanol for systemic administration and its use as a modulator of immune and inflammatory responses. Background technique [0003] Polydocanol or PEG-9 lauryl alcohol is a polyglycol ether of lauryl alcohol having an average value equal to 9 ethylene oxide units. It belongs to the category of nonionic surfactants and is represented by the structural formula shown below: [0004] [0005] In the past, this compound has been widely used as an additive / excipient in various formulations and for various applications. [0006] The use of polidocanol as a local anesthetic and antipruritic began around 1950 and is still used today in topical formulations, eg for the treatment of dermatitis, eczema and insect bites. [0007] In the 60's, polidocanol was first used as a tissue sclerosing agent in the treatment of small and reticular varicose veins. It is currently used primarily for this pur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/08A61K38/34A61P37/02A61P23/02A61P29/00A61P17/00A61P23/00
CPCA61K31/08A61P17/00A61P23/00A61P23/02A61P29/00A61P37/02A61P29/02
Inventor 保罗·卡索尼
Owner 保罗卡索尼
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