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)
- Scratch Patch Test
- Local Eye Tolerance
Bioequivalence of topical medicinal products
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.
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.