Clinical trials with medicinal products and medical devices

Be it the exclusion of an irritative or allergenic potential, the proof of bioequivalence or an efficacy investigation – we are available to you as an experienced and competent full-service partner with internationally recognized study protocols which cover the requirements of European and US regulatory authorities, to carry out GCP-compliant clinical trials as well as trials subject to regulatory approval. We carry these out in compliance with the relevant statutory requirements, guidelines, and standards for dermatological, allergological, ophthalmic and dental medicinal products as well as for medical devices. As a rule, we carry out your testing assignment as part of a monocentric study at our main site in Schenefeld near Hamburg. If necessary, we can also offer you a multi-center trial based on our network of qualified test centers. We are happy to conduct the following studies for you:

  • Safety studies (Phase I)
  • PK-studies (Phase I)
  • Proof-of-Principle/Proof-of-Concept (Phase II a)
  • Dose finding (Phase II a/b)
  • Pivotal Studies (Phase III)
  • Postmarketing Studies (Phase IV)
  • Bioequivalence studies

proDERM | Your partner for trustworthy clinical studies.

In Dermatology, Oral Care, Ophthalmology, Hair Care, Women’s Health and Sun Care

Local tolerability of topical medicinal products

When determining the local tolerability of a product, irritative and allergenic potentials must be excluded. If the formulation contains active substances or excipients that absorb within the UV spectrum, the photoallergenic potential must also be excluded. But for rarer issues as well, such as tolerability on mucous membranes or wounds, we have standard protocols and extensive experience at our disposal.

  • 21 Day Cumulative Irritation Patch Test
  • Human Repeat Insult Patch Test (HRIPT)
  • Repeated Open Application Test (ROAT)
  • Phototoxicity
  • Photosensitization
  • Scratch Patch Test
  • Local Eye Tolerance

Bioequivalence of topical medicinal products – the vasoconstriction test

In contrast to systemically available medications, there are very few possibilities for proving the bioequivalence of topically applied medications without a clinical study on patients. An important exception in this case is the corticosteroids. For these, we offer the vasoconstriction test in accordance with FDA guidance. Because of its comprehensive experience in conducting this test, proDERM already has a prescreened panel of “responders”. For other substances, it is increasingly possible to demonstrate bioequivalence by dermatopharmacokinetic parameters using Raman spectroscopy.

Efficacy of topical medicinal products

Proof of concept studies are conducted on symptomatic test subjects and represent a huge challenge when it comes to recruitment. proDERM, however, already has a pool of appropriately prescreened studies. Thus, we can reduce time of recruitment and increase the compliance. In addition to standard Proof of Concept studies with patients we also offer numerous models to generate symptoms enabling us to investigate anti-inflammatory efficacy, local anaesthetic effects or reduction of pruritus in healthy subjects in a timely manner.

Clinical Assessment of Medical Devices

Now, with the 4th revision of the Guideline, the requirements for the evaluation, testing and certification of medical devices have increased significantly. Specifically, the Guideline now describes, in very much more detail, how and over what period of time a clinical assessment is to be conducted. In addition, specifications regarding the data collection and literature search are given. A significant modification is the compulsory handover of the assessment protocol that describes the methods used in the clinical evaluation and the steps performed. In addition, the room for interpretation in the use of data of a comparison product is significantly reduced by the Guideline’s revision.

In the framework of the certification of your medical device, our team of scientists and physicians is available to you as a competent service provider for clinical evaluations, and as a ‘Think Tank’. Our support ranges from well-designed, scientific studies on the conduct of literature searches to the creation of experts‘ reports or concept papers. It is especially in the case of semi-solid topical formulations for application to the skin or in the eye that our many years of experience in dermatology and ophthalmology excels.

Examples of this are artificial tears for application in the eye and products for the improvement of the skin barrier.

Special study populations in clinical studies

The types of studies we offer are carried out on both healthy test subjects and symptomatic patients. The recruitment for your study is performed primarily on the basis of our extensive test subject and patient database, which can be conveniently filtered for study-relevant parameters. In addition, we have a network of dermatology testing centers and a wealth of honorary staff who support us in extreme recruitment situations. This enables us to successfully handle even the most difficult recruiting conditions. Our database includes the following special collectives, among others:

  • Rosacea
  • Psoriasis
  • Atopic Dermatitis
  • Acne
  • Herpes labialis
  • Active keratoses
  • Contact allergy
  • Pollinosis
  • Dermatoporosis
  • Nail fungus