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About proDERM Approach Service Study types Equipment Quality Consulting Site Management Publications

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| About proDERM

Trusted Partner

What started as a dermatological CRO in

1994 is today a clinical research service

provider with an unmatched range of

metho-dology, equipment and highly dedicated

scientific experts.

proDERM was founded in 1994 by Klaus-P. Wilhelm, MD, Professor of Dermatology, a renow-ned specialist in dermatopharmacology and dermatotoxicology.

With the motto 'Dedicated to Skin', the proDERM research team has been dedicated since then, body and soul, to conducting clinical dermatological studies.

This clear focus has been expanded over the years by other core areas such as the indications of ophthalmology, oral hygiene and hair care. Nevertheless, even after almost 20 years of work, proDERM stands primarily for one thing: Continuity!

Continuous growth, continuous leadership, continuous

indepen-dence - last but not least a continuously expanding scientific

methods of highest quality.

1994 | Foundation of proDERM

# of employees: 4 | # of studies p.a.: 40

1995 | Implementation of Pharmaceutical Division

5

16

1997 | Opening of Sun Protection Laboratory

2000 | Establishment of Deodorant and Antiperspirant Facilities 2002 | Start of Hair Care Laboratory

2007 | Incorporation of Oral Care Clinic

23 29 36 43 50 75 86 95 No. of employees Milestones

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| Services

Full Service

From early phase consulting until archiving

of study data - we are the professional,

flexible, and trustworthy partner for your

development project.

proDERM covers all aspects of a clinical trial. Thus, customers have the opportunity to

individually define the type and scope of the desired service from our range of services.

Cooperation usually starts with the development of an optimal study design and con-tinues with obtaining the regulatory approval. After suitable patients or volunteers are

recruited and the study is conducted in our clinical unit, the project is finalized by Data

Management, Statistics and Medical Writing.

Regardless of the type and scope of the project, with a total of 95 employees, we always

assure that there is a substitute for all functions. With that we can react with high flexibi -lity to the needs of our customers, even in times of high workload.

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Consultancy

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Regulatory Approval

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Patient Recruitment

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Project Management

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Data Management

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Statistics

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Report Writing

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Archiving

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| Approach

Providing Professional Solutions

Dedicated experts, innovative equipment

and experience are the success

ingre-dients of the professional solutions we

offer for both individual and standard

study objectives.

We combine our passion for clinical research with our approach towards quality. For this

reason, proDERM stands not only for dedication, but also for professionalism, scientific

methods and innovation.

This is the foundation of our daily work, in which the needs of our customers take center stage. This is also our impetus for continuously striving for improvement.

There are no differences made. Whether a top ten global player, a medium-sized enter -prise or a startup, whether a standard test or an individual study design –

our principles are applied to all projects at all times.

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Professional

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Scientific

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Innovative

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| Study types

| Safety &

Tolerance

proDERM conducts clinical phase I/IIa trials for pharmaceuticals, medical devices, cos-metics, food supplements and consumer products.

In most cases, it is a matter of proving the tolerability or efficacy of topically applied

products. Systemically acting products are also investigated as long as the primary target criteria are the effects on the skin or mucous membrane.

With the proDERM Pharma and proDERM Cosmetics departments, proDERM is em-bracing the fact that the regulatory environment and thus the conditions for a clinical trial vary greatly depending on the product to be tested.

Under the direction of Dr. Reinhold Gahlmann, proDERM Pharma investigates in pre-dominantly monocentric trials:

• the local tolerability of topical medicines • the bioequivalence of corticosteroids

• the efficacy of drugs or topical medical devices in proof-of-concept studies.

At the same time, proDERM Pharma has a network of qualified investigators in clinics

and practices for multi-center studies.

Stefan Bielfeldt and his team in the proDERM Cosmetics Division focus on the

tolera-bility and proof of efficacy of cosmetics, food supplements and consumer products.

| Efficacy &

Claim Support

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Pharmaceuticals

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Medical Devices

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Cosmetics

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Food Supplements

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Consumer goods

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Skin Care

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Oral Care

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Hair Care

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Eye Care

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Sun Protection

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Intimate Hygiene

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| Equipment

Experienced, Innovative,

One of a Kind

The multitude of innovative technologies (i.e.

Raman Spectroscopy) and the extensive

knowledge of our researchers to apply these

techniques make us a one of a kind CRO.

Our technical equipment goes far beyond known standards and is unique in the global CRO landscape. Thus, we are, for example, one of the few institutes that can offer the non-invasi-ve technologies of confocal microscopy and Raman spectroscopy in combination.

At the same time, we set benchmarks by our own developments. With our USR-CliP (Unit

for Standardized and Reproducible Clinical Photography), we can, for example, achieve a high level of reproducibility and color fidelity in clinical photography. Our MacIS (Macrosco

-pic Imaging System), on the other hand, allows unparalleled standardized macro photogra -phy.

In our tests, we combine the various technologies in a validated environment and can thus present our sponsors with undreamt of solutions.

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3D Scanners for Profilometry

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In-vivo Confocal Microscopy

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In-vivo Confocal Raman Spectroscopy

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Clinical Photography

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IR Thermography

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Laser Perfusion Imaging

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Radiometers

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Videomicroscopy

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UV Radiation Devices

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| Quality

Comprehensive Quality

Management and ISO

Certification

Our service is of high quality, and we attach great importance to this. It is therefore not surprising that our quality management system goes far beyond the standards and we

are the first German dermatological CRO to have received ISO certification.

Compliance with ethical standards, current legal requirements and standards, the assu-rance of credible and valid data, reliable compliance with target dates and, last but not least, the continuous improvement of our products and services are aspects that we

em-phasize in our quality management system.

Our system of standard operating procedures,

qua-lity control, qualification and training has proven

itself in audits by customers and authorities, and

is certified according to ISO 9001.

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Quality Control

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System Audits

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Study Audits

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Validation

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Qualification

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Training

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| Consulting

100 Years of Clinical Research

Experience

Make use of our problem-solving capabili

-ties and go the right path from the very

beginning.

You are not going the way of the standards but are blazing a new trail with your pro

-duct. Your innovative formulations require a pioneering spirit and scientific excellence

of the clinical implementation. Your product offers properties that cannot be proven by conventional methods.

Institute founder Prof. Dr. Klaus-P. Wilhelm and the senior consultant team with Dr. Reinhold Gahlmann, Stefan Bielfeldt and Dr. Dorothea Wilhelm will steer your project in the desired direction from the very start with their over 100 years of combined experi-ence. In addition, you will be taken care of by experts who, with experience from more than 6,000 studies and over 30,000 examined products, will hold the steering wheel

firmly in their hand and accompany you on your way with advice and action to solve

even the greatest challenges.

Because of our extensive inventory of technical equipment, you will benefit from a maxi

-mum of flexibility and methods developed explicitly for your project.

.

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Comprehensive publications

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Comprehensive academic network

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Close contacts to

responsible authorities

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Active in national and international working

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| Site

Management

Beyond Phase I: Hospitals and

Dermatologic Offices

Master the multicenter challenge with the

proDERM network of qualified investigators.

The distinctive idea of service, the passion for clinical research, the demands for quality and

professionalism - our test centers have been qualified in multiple ways in order to be inclu -ded in our network of clinical testing facilities.

As the primary responsible CRO, we will gladly support your project with this established network through and beyond phase I in the multicenter phases of development. Of course, the multicenter study can also be the start of our collaboration.

Whether starting or continuing a successful cooperation, we assume the following tasks:

• Creating the test protocol

• Obtaining the regulatory approvals and ethics opinions • Organization of the investigator's meeting

• Training & evaluator calibration • Site initiation • Monitoring • Data management • Statistics • Report writing

| Publications

Extract of recent Publications

Bielfeldt S, Röck C and Wilhelm KP, Chances and limits of an improved method to assess water resistance of cosmetic sunscreen products in vitro on polymethylmethacrylate pla-tes. Int J Cosmet Sci: 1-5, 2012.

Bielfeldt S, Henss R, Koop U, Degwert J, Heinrich U, Jassoy C, Meyer J, Tronnier H,

Jentzsch A and Blume G, Internet-based lay person rating of facial photographs to assess

effects of a cleansing product and a decent cosmetic foundation on the attractiveness of female faces. Int J Cosmet Sci: 1-5,2012.

Wilhelm D, Himmelmann A, Axmann E-M, Wilhelm K-P, Clinical efficacy of a new tooth

and tongue gel applied with a tongue cleaner in reducing oral halitosis, Quintessence Int, 43:709–718, 2012

Daehnhardt-Pfeiffer S, Surber C, Wilhelm K-P, Daehnhardt D, Springmann G, Boettcher M, Foelster-Holst R, Noninvasive stratum corneum sampling and electron microscopical exa-mination of skin barrier integrity: pilot study with a topical glycerin formulation for atopic dermatitis, Skin Pharmacol Physiol 25, 155, 2012.

Steiling W, Buttgereit P, Hall B, O'Keeffe L, Safford B, Tozer S and Coroama M, Skin expo -sure to deodorants/antiperspirants in aerosol form. Food Chem Toxicol, 50: 2206-2215, 2012.

Bielfeldt S, Böhling A and Wilhelm K-P, Bioengineering methods to assess aging parame-ters in the depth of the skin. SOFW Journal, 137: 2-9, 2011.

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References

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