Unique

know-how

Research &

development

Clinical

trials

RESEARCH AND DEVELOPMENT OF DERMATOLOGICAL MEDICAL DEVICES

Laboratoires Carilene History

Over the last 30 years, Laboratoires Carilène have demonstrated the therapeutic properties of OGT (Oxidised Glycerol Triester) by mechanical effect. For more than 30 years, Laboratoires Carilène have investigated, tried and tested new OGT fields of therapeutic applications. Pharmaceutical research relies frequently on traditional medicine sourcing. Laboratoires Carilène have screened the medical potential of some oxidised fatty acids recommended by Oriental medicine. As a result of their observation, they formulated a range of original products validated by clinical studies and developed a new therapeutic family. Numbers of patents protect the manufacturing process, the indications and commercialisation of most of the OGT base products.

certification

EPALINE 100 & EPALINE DM
“Raw materials approved by ECOCERT GREENLIFE, comply with the COSMOS standard”.

New certification for Laboratoires CARILENE: obtaining of “COSMOS Certification” in connection with peroxidized oils - EPALINE 100 & EPALINE DM. COSMOS certification was carried out by an independent and recognized control body in the field of Organic & natural Cosmetics: ECOCERT GREENLIFE. The peroxidized oils called: EPALINE 100 * - Peroxidized Corn Oil EPALINE DM * - Peroxidized Deodorized Corn Oil comply with the requirements of the COSMOS “Cosmetics Organic & Natural Standard” ** version V3.0 - September 2018. These raw materials also meet the requirements of Regulation (EC) 1906/2006 REACH as a "substance for the Cosmetics Industry & for Medical Devices" *. This certification granted by "Ecocert Greenlife" is the result of a voluntary process undertaken by Laboratoires CARILENE, the objective of which is to meet current needs in terms of conformity of products of natural origin. The main commitment of Laboratoires CARILENE remains the satisfaction of customer expectations and needs while promoting the guarantee of providing products and services offering a high degree of quality and innovation.


*EPALINE 100 – EPALINE DM – TGO: INCI name: Oxidized corn oil - REACH number: 01-2120745900-56-0000
** COSMOS (COSMetic Organic Standard) is a private standard on a European scale developed by five founding members: BDIH (Germany) / Cosmebio (France) / ECOCERT Greenlife SAS (France) / ICEA (Italy) / Soil Association (Great Britain).




certification


Laboratoires Carilène are ISO 13485 version 2016 certified for "MANUFACTURING AND MARKETING OF PEROXIDIZED OILS and MANUFACTURING AND MARKETING OF MEDICAL DEVICES BASED ON THESE PEROXIDIZED OILS. "

Laboratoires Carilène have a Quality Policy meeting the regulatory requirements of the ISO13485: 2016 standard & the current Medical Device regulations, Directive 93/42 / EEC & amendments but also the new requirements of the EC Regulation 2017/745 implemented. This certification is a guarantee of the involvement of management and all staff in the quality of products and services. All members of the company accept responsibility for the quality of the products. They are aware of the challenges and needs of their customers, and their objective is to offer a high level of quality to medical devices & peroxidized oils marketed as part of their activities.

Laboratoires CARILENE define their Quality Policy around these 5 main axes: :
COMPLIANCE / CUSTOMER REQUIREMENTS / EFFICIENCY & EFFICIENCY / COMMITMENT

Certification certificates are available on written request from CARILENE Laboratories – contact@carilene.fr

  • Stéphane Desjonqueres is the president of Laboratoires Carilène
    which he founded in 1982.

    Jack Black
    Stéphane Desjonquères, Président

Oxidised Glycerol Triester

resulting from vegetable oil oxydation

  • An original chemistry
    Laboratoires Carilène have developed a unique controlled oxidation process for the manufacture of Oxidised Glycerol Triester. Laboratoires Carilène produce their oxidised compounds in their industrial site in full compliance with the in-house procedures of their Quality Assurance System ISO 13485 version 2016.

  • Industrial reliability
    Laboratoires Carilène have full control of the industrial know-how of OGT. The oxidation is continuously monitored by an ‘’in-process control’’ which consists in the measure of the peroxide index. Over the last thirty years, Laboratoires Carilene have been the pioneers of the industrialisation of the controlled oxidation process of vegetable oils.

  • CARILENE’S RANGE OF MEDICAL DEVICES
    Based on demonstrated biomechanical properties, OGT by topical application open up a broad spectrum of therapeutic fields. Topical application of OGT generates a protective lipidic film on the skin and/or mucous membranes generating a soothing effect.

  • Over the last thirty years, Laboratoires Carilene have been the pioneers of the industrialisation of the controlled oxidation process of vegetable oils.

    Jack Black
    Stéphane Desjonquères, Président

COSMETIC INDUSTRY

OGT, tolerance factor

Tolerance of cosmetic preparations is an essential concern of the cosmetic industry. Formulation of many cosmetic products will derive full benefit to include a given percentage of OGT, and so doing, promote a product well tolerated. For more than 30 years, Laboratoires Carilene deliver to the cosmetic industry an important supply of OGT. These new cosmetic formulations permit to secure the tolerance factor without alteration of the cosmetic value of their products.

 

Innovation

Innovation is the heart of Laboratoires Carilene culture.

They consequently developed a number of applications with their peroxidised oils in various fields such as the treatment of herpes symptoms, the relief of xerostomia symptoms, the prevention of pressure ulcers and Stop hair loss. These innovations are internationally patented. This innovation process is continuous and some patents are still on-going.

RESEARCH AND DEVELOPMENT

Laboratoires Carilene have been involved for many years in a clinical investigations program related to medical devices containing mainly the peroxidised oils they manufacture.

HERPECARE (RD2)

Evaluation of the efficacy and safety of the product HERPECARE, covering and protecting gel, indicated in functional symptoms of genital herpes, in a randomised, multicentre, comparative study, carried out in simple blind investigator, on patients suffering of recurrent genital herpes (2011).

ACURA (RD1)

Evaluation of the efficacy and safety of the product CS 20, covering and protecting gel, indicated in functional symptoms of labial herpes, in a randomised, multicentre, comparative study, carried out in simple blind investigator, on patients suffering of recurrent labial herpes (2010).

AEQUASYAL

Evaluation of the efficacy and safety of the product AEQUASYAL indicated in the relief of the symptoms and signs of xerostomia in a randomised, multicentre study, carried out in two parallel groups on patients suffering from xerostomia (2005).

On-going developments

Les Laboratoires Carilène continue their R&D work in several new indications. NEW DESIGN PROJECTS CAN BE IMPLEMENTED INCLUDING FORMULATION AND CLINICAL INVESTIGATION STAGES FOR ANY NEW REFERENCES.

PARTERSHIP

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