CARILÈNE LABORATORIES
Research and Development of Dermatological Medical Devices
History
For over 40 years, Carilène Laboratories have explored numerous application areas for peroxided oils, pioneering the industrialization of the controlled oxidation process for vegetable oils. Based on demonstrated physicochemical properties, Oxidized Glycerol Triesters (OGT), named EPALINE®, open up a wide therapeutic universe for local application.
Peroxided vegetable oils induce the formation of a protective lipid film on the skin or mucous membranes, promoting the healing and regeneration of inflamed or damaged tissues. The tolerance and performance of each new product developed by Carilène Laboratories are demonstrated through biological evaluation tests and clinical investigations in accordance with European regulatory requirements.
Product patents or application patents protect all references in the range of products developed and marketed by Carilène Laboratories.
Presentation of Carilène Laboratories
Carilène Laboratories specialize in the Research & Development of dermatological medical devices.
“Manufacturers” of Oxidized Glycerol Triesters derived from essential vegetable fatty acids, these peroxided vegetable oils are intended for the Cosmetic industry and the Medical Device industry.
Carilène Laboratories are also “Manufacturers” of Medical Devices within the meaning of Medical Device Regulations, with production outsourced in “Full-service” to contractors located in Europe.
Our primary commitment is to provide quality health products with a high degree of safety, meeting regulatory requirements and the expectations of customers and patients.
As a leader in the field of dermatological medical devices, we ensure global control of all stages from design to market placement of MDs, with post-market surveillance also managed within our ISO 13485:2016 certified Quality Management System.
Certifications
Carilène Laboratories’ Quality Management System is ISO 13485:2016 certified for “THE MANUFACTURING AND MARKETING OF PEROXIDED OILS AND THE MANUFACTURING AND MARKETING OF MEDICAL DEVICES BASED ON THESE PEROXIDED OILS.”
EPALINE® 100 & EPALINE® DM
“Raw Materials approved by ECOCERT GREENLIFE, in accordance with the COSMOS Standard.”
OGT
A unique original process
Carilène Laboratories implement the specific controlled oxidation process for vegetable oils, thereby manufacturing Oxidized Glycerol Triesters, named EPALINE®.
L’unité industrielle de l’EPALINE® est située à Naples en Italie.
The Quality Management System complies with ISO 13485 version 2016
Medical Devices
Developed by Carilène Laboratories and validated by clinical studies
Aequasyal
DRY MOUTH
Relief of the signs and symptoms of xerostomia through a protective lipid film on mucous membranes
Herpecare
GENITAL HERPES
Covering and protective gel acting on the functional signs of genital herpes.
Acura
LABIAL HERPES
Covering and protective gel acting on the functional signs of labial herpes.
COSMETIC INDUSTRY
EPALINE® — Tolerance Factor
The tolerance of cosmetic preparations is a key concern for dermo-cosmetic manufacturers.
La formulation de nombreux produits cosmétiques incluant un certain pourcentage de OGT permet d’obtenir et de commercialiser des produits bien tolérés.
L’EPALINE® est la gamme d’huiles peroxydées développée par les Laboratoires Carilène pour l’industrie cosmétique.
For over 40 years, Carilène Laboratories have supplied a large quantity of OGT to the international cosmetic industry. The tolerance of these new cosmetic formulations is thus ensured without any alteration of product value.
EPALINE® 100 and EPALINE® DM comply with the requirements of the COSMOS standard (Cosmetics Organic & Natural Standard) and are approved by ECOCERT GREENLIFE.
Research AND Development
Carilène Laboratories have been engaged for many years in a clinical investigation program on medical devices primarily containing the peroxided oils they manufacture.
HERPECARE® (RD2)
Evaluation of the activity and tolerance of HERPECARE®, a covering and protective gel, on the functional signs of genital herpes. A multicenter randomized single-blind investigator study conducted on patients with a history of recurrent genital herpes (2011).
ACURA® (RD1)
Evaluation of the activity and tolerance of ACURA®, a covering and protective gel, on the functional signs of labial herpes. A monocentric randomized single-blind investigator study conducted on patients with a history of recurrent labial herpes (2010).
AEQUASYAL® (CS18)
Evaluation of the activity, tolerance, and acceptability of AEQUASYAL® in relieving the signs and symptoms of xerostomia. A multicenter randomized single-blind investigator study conducted on patients suffering from xerostomia (2005).
Ongoing Research
Carilène Laboratories continue their R&D work in several new indications. New design projects can be implemented, including formulation and clinical investigation stages for any new reference.
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// Cosmetics
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The EPALINE® production unit
Controlled oxidation process conducted in a dedicated unit, under a Quality Management System compliant with ISO 13485:2016.
Contacts
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CARILÈNE LABORATORIES
Head Office:
Tour Franklin, 100-101 Terrasse Boieldieu
92800 Puteaux — FRANCE
Administrative Office:
5 rue du Helder
75009 Paris — FRANCE
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