Anti-Pollution, Blue Light, Skin Microbiome

Register to our ‚Hot Topics‘-Webinar scheduled for 30.1.2020, 3 pm cet

Hot Topics in Cosmetic Claims Support – Anti Pollution, Blue Light, Skin Microbiome

Delegates of this webinar will be introduced into the latest advancements of the three major cosmetic trends in recent years: Anti-Pollution, Skin Microbiome and Blue Light. After explaining the scientific background, concepts for appropriate claims support will be presented. As a delegate, you will be provided with our recent clinical trial learnings including the presentation of example studies results. The webinar will be given by Stephan Bielfeldt, Vice President and Director Science & Innovation of proDERM. In the end of the presentation, you will have the chance to submit your questions using the webinar chat.

Presenter:
Stephan Bielfeldt
Vice President and Director Science and Innovation

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Clinical photography

New possibilities in facial photography, study documentation and image analysis

Clinical photography

New possibilities in facial photography, study documentation and image analysis

We have expanded our service in the field of clinical photography and purchased the Colorface® system from the French company Newtone. Colorface® is a standardized system for capturing the entire face with multiple lighting modalities and views. Subsequently Newtone offers both standardized and customized image analysis. A special feature is “Mean Face”, a face that is composed of all participants of a study and shows the average effects.

Due to this special focus on facial photography, Colorface® is a useful addition to the existing image recording options such as the proDERM USR CliP.

The system can applied in the following fields of application:

  • Standardized photography
  • Redness
  • Rosacea
  • Skin colour
  • Skin surface
  • Porphyrins
  • Wrinkles
  • Pores
  • Pigmentation
  • Gloss
  • Dark circles under the eyes
  • Homogeneity
  • Blackheads
  • Acne
  • Melasma
  • Lips
  • Eyebrows
  • Foundation

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4.11.2020: The Medical Devices Seminar

Medical Devices in the EU – Challenges after May 2020

4.11.2020: The Medical Devices Seminar

Medical Devices in the EU – Challenges after May 2020

Why this seminar?

The new Medical Devices Directive 2017/745 comes into force on the 26th of May 2020. Manufacturers, distributors, Notified Bodies and other players in the field of medical devices have to adapt to massive changes according to the directive. On the 4th and 5th November of this year, we are gathering experts from the medical device industry in Hamburg to inform you about the changes mentioned above and to enable you to exchange information directly.

In this seminar:

  • you will get an overview of the requirements of MDR
  • you will learn how challenges are acted upon and solved by different parties
  • you will examine the problems from different perspectives together with the experts
  • you will receive answers to urgent questions, which allows you to prepare for the future
  • you will be able to obtain the opinions of various stakeholders in the final panel discussion

We are currently working out the program and the schedule of the event in detail. We will be able to provide you further information shortly. You are welcome to register for our E-Alert. In this case we will automatically provide you with the relevant information.

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Eye Irritation, Eye Tolerability, No-Tears-Claim

About the importance and possibilities in the field of eye tolerance research

Eye Irritation, Eye Tolerability, No-Tears-Claim

About the importance and possibilities in the field of eye tolerance research

There is no panacea that guarantees you success with your product on the market. The factors are too complex for that. Nevertheless, there are aspects to which you must pay attention in the context of product development. These certainly include the question of the compatibility of your product. Your chances of success are poor if consumers believe that your product is causing intolerances. This has become all the more important in times of digital communication and social networks, as consumers can exchange information across borders and in short periods of time. In the world of clinical research, the testing of a product’s tolerability is primarily associated with the examination of skin compatibility in form of common patch tests. Since our foundation in 1994, these tests have been part of our standard. You can find a corresponding overview of our services here.

How is your product used?

It is also essential that you ask yourself how the consumer uses your product. If contact with the area around the eyes is possible – intentionally or unintentionally -, you should include the evaluation of the eye tolerability of the product in your development strategy. The procedures we offer, like the Human Eye Irritation Test and the Eye Tolerability Test, differ in terms of intensity and objectives.

Human Eye Irritation Test

In this study, we apply the test product in diluted or undiluted form to one eye and a reference product to the other eye. The concentration of the test product is tested and determined in advance by using a small number of study participants. At certain points in time, parameters such as lacrimation, palpebral irritation and bulbar irritation (certain areas of the conjunctiva) and scleral vasodilatation (deeper vessels in the eye) are examined by an ophthalmologist in a slit-lamp inspection. At the same time, a subjective assessment is made by the test person with regard to the parameters tingling, prickling, burning, pricking and itching. The primary and only objective of this study is to evaluate the tolerability in the eye. If the study participant still feels a stronger burning, stinging or itching after 15 minutes, this indicates poor tolerance of the product. If the ophthalmologist also notices an affected scleral, i.e. the deeper vessels, the product appears to cause more irritation, which also indicates poor tolerability.

Eye Tolerability Test

In addition to eye tolerance, there is often the desire to examine the irritation of the skin and/or the effectiveness of the product in the area of application. The appropriate procedure for this scenario is the Eye Tolerability Test. In this test, the product is handed out to the study participants and will be applied according to the protocol in a phase of one week or several weeks. With regard to the secondary objective, the eye tolerability, an ophthalmological evaluation of the following parameters is performed both before and after the application of the product: Eczema of the eyelids, conjunctivitis, follicles in the conjunctiva, blistered conjunctiva swelling and tolerance on the eyelids. In addition, a subjective evaluation is made by the test person.

‘No Tears’ or ‘Tears-Free’

Especially for shampoos, shower gles and baby products it may be of interest for manufacturers to prove the special eye tolerance claim ‘No Tears’ (common alternatives: ‘No More Tears’, ‘Tears Free’, ‘Kind to Eyes’ etc). We would prove this with the Human Eye Irritation Test described above.

We will be happy to answer any questions about our services in the field of ‘Eye Care’. As a precautionary measure, we have listed the various procedures and backgrounds for you in our FactSheet ‘Ophthalmological Control’. You can request the FactSheet via the following link.

FACTSHEET OPHTHALMOLOGICAL CONTROL




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In-vivo Determination of the Sun Protection Factor

proDERM conducts studies according to the new standard DIN EN ISO 24444:2019

In vivo determination of the sun protection factor

proDERM conducts studies according to the new standard DIN EN ISO 24444:2019

The procedure for in vivo determination of the sun protection factor is regulated by DIN EN ISO 24444. This standard has to be applied to all sunscreen products that are intended to come into contact with human skin, including any components that may absorb, reflect or scatter ultraviolet radiation. 1

The ISO (International Organization for Standardization) has recently prepared a revision of the standard, which now is available in version 24444:2019. The revision includes the following changes:

  • The definition of the minimal erythema response (MED) criteria has been revised
  • Enrolment of study subjects shall be based on ITA° classification
  • The ITA° is used to define the range of unprotected MED doses for the provisional or the test day unprotected MED determination (if no provisional MEDu determination is made)
  • Three new Reference Standards (P5, P6, P8) were validated and shall be applied in studies with Sun Protection Products having a protection factor of ≥ 25
  • The guideline includes new test methods which shall guarantee the uniformity of big and small solar simulators
  • The product application procedure is described in more detail
  • With the Annex F the guideline now includes photographic examples of erythemic reactions as well as instructions for evaluation
  • Modifications to evaluation tables listed in Annex G and the requirements of Clause 11 have been made
  • The library has been updated

We have modified our method for the determination of the sun protection factor in accordance with the new standard. With that, we can carry out the determination in accordance with the latest version of the standard.

If you have any questions about our portfolio in the field of sun protection or about the new features of the standard, please don’t hesitate to contact Stephan Bielfeldt, Vice President and Director Research at proDERM. Please use the contact form below.

1 https:a//www.beuth.de/de/norm/din-en-iso-24444/126570861

FAQ - TESTING OF SUN PROTECTION PRODUCTS




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Our Team Grows

Let us introduce our new colleagues to you

Our Team Grows

Let us introduce our new colleagues to you

At the beginning of this year, our workforce grew once again. Up to now we count 95 FTEs (Full Time Equivalents) and our Human Resources Manager, Ms. Franziska Laboch, has recently announced further new hires. Just recently, Ghaith Kourbaj, Lorena Bechthold, Carolin Mull and Carlos Heras Bautista (shown above, from left to right) have joined our team. We would like to inform you briefly about their main focus:

Ghaith Kourbaj
Ghaith Kourbaj received an employment contract on the 1st of January 2020. Previously he completed his master’s thesis with the title: ‘Measurement of Dermal Water Content by Confocal Raman Spectroscopy to Investigate Intrinsic Aging and Photoaging of Human Skin In Vivo’ at proDERM. He now supports us in our ‘Development and Technical Services’ department, which is responsible for the management and further development of our technical and methodological services. His focus will remain on Raman methodology.

Lorena Bechthold
Dr. Lorena Bechthold strengthens our Business Development department. Lorena holds a PhD in Materials Science from the University of Manchester. In cooperation with the company Henkel AG & CO. KGaA, Germany she successfully developed a novel measurement method for the quantification of the hair movement. Her doctoral thesis was awarded with the SEPAWA Young Researcher Award 2019. You can already meet Lorena personally at the IMCAS (International Masters Course of Aging Skin) in Paris from the 30th of January to the 1st of February 2020.

Carolin Mull
Dr. Carolin Mull supports the team Clinical Operations as project manager. The team Clinical Operations is responsible for the execution of clinical studies with drugs and medical devices. She is a trained biotechnologist and completed her doctorate at the University Medical Center Hamburg-Eppendorf. Carolin will supervise the clinical studies and will be one of your primary contact persons.

Carlos Heras Bautista
Dr. Carlos Heras Bautista joins the team Data Operations as data analyst. In this team, he previously worked as an intern. His main focus will be the programming of SAS, VBA and SQL and the topic of automation. Prior to his further training as Clinical Data Manager, Carlos obtained a Master’s degree in Biomedical Engineering at the University of Applied Sciences in Aachen. Afterwards he completed his doctorate in biomaterials in Cologne.

ISO 9001:2015

Repeatedly certified quality management

ISO 9001:2015

Repeatedly certified quality management

We are pleased to inform you that the conformity of our management system with the standard(s) according to ISO 9001:2015 was confirmed in a three-day audit by the certification body DNV-GL. Thus, 18 years after our initial certification, it has been repeatedly determined that we meet the requirements of ISO.

The following topics, among others, were the subject of the audit:

  • Company structure
  • Internal communication
  • Organizational changes
  • Company goals
  • Living the mission statement
  • Continuous improvement
  • Control of documents and records
  • Continuous improvement
  • Visit of the new facilities
  • Processes and structures
  • Staff recruitment
  • Familiarization, training plans & training organization, training of the MA
  • Training of SOPs and other specification documents
  • Training & Documentation
  • Use of equipment in studies
  • Data backup / electronic archiving

Events

Where you can meet us in 2020

Events

Where you can meet us in 2020

At the beginning of the year we would like to give you an outlook on our congress and trade fair participations. The events ‘IMCAS’ and ‘VIVANESS’ in Paris and Nuremberg are coming soon. The ‘Vivaness’ is a trade exhibition for natural cosmetics. IMCAS’ is organized by the International Masters Course of Aging Skin and the main focus will be on the science of ageing, dermatology and aesthetic surgery.

If you are planning to visit one of these events, we would be very happy to meet you there. You are welcome to make an appointment with us in advance. Please send an email to our Business Development Manager Ms. Kathrin Friedrichsen. Below you will find a complete overview of the business event participations currently planned. Below you will find a complete overview of planned event participations.

You can meet with us at the following events:

  • 30.1.-1.2.2020: IMCAS World Congress, Paris
  • 12.2.-15.2.2020: Vivaness, Nuremberg
  • 20.-24.3.2020: AAD Annual Meeting, Denver
  • 18.3.-21.3.2020: IADR/AADR/CADR General Session & Exhibition, Washington, D.C.
  • 31.3.-2.4.2020: in-cosmetics global. Barcelona
  • 14.4.-17.4.2020: 17th Perspectives in Percutaneous Penetration Conference, La Grande Motte
  • 5.-6.5.2020: Supplier`s Day, New York
  • 7.5.2020: Sepawa CAT, Mainz
  • 12.5.-13.5.2020: DGK Forum Cosmeticum, Berlin
  • 27.5.-28.5.2020: Deutsche Biotechnologietage, Wiesbaden
  • 2.6.-3.6.: Anti Aging Skin Care Conference, London
  • 3.-.5.6.2020: PCMG – Pharmaceutical Contracts Management Group / Congress, Krakow
  • 3.-.5.6.2020: International Applied Hair Science Conference (TRI), Red Bank
  • 8.10.-11.10.2020: German Ophthalmology Society Congress, Berlin
  • 28.10.-30.10.2020: Sepawa Congress, Berlin
  • 28.10.-1.11.2020: 29th EADV Congress, Wien
  • 10.11.-12.11.2020: Dermatology Drug Development Summit, Boston
  • 16.11.-19.11.2020: Medica/Compamed, Düsseldorf