Clinical Dermatology
Fargo
| East Grand Forks |
Dermatology
The PRACS
commitment to clinical research
PRACS Institute conducts safety, efficacy and claims substantiation testing
for the skin care, chemical and consumer product industries.
PRACS Institute also serves as an investigational clinical research site for multi-center
topical pharmaceutical trials.
We understand the importance of high quality work delivered on time and on budget and the correct interpretation of clinical results. Our dermatology studies are led by experienced personnel who have worked in the skin and personal care industries, giving us a unique appreciation of the needs of our clients.
Advantages of using PRACS as your service provider| • Trained visual grading | |
| • Complete bioinstrumentation capabilities | |
| • Cold and Dry upper Midwest climate (ideal for dry skin testing) | |
| • Experienced in Dry Skin and Moisturization studies | |
| • Experienced in Vasoconstrictor assays following the FDA Guidance | |
| • Rapid study recruitment with exceptionally compliant subjects |
Our Dermatology team conducts routine and custom testing of a wide variety of products in the following categories:
| Human Safety Testing | |
| • Acute primary irritation | |
| • Cumulative irritation | |
| • Medical device compatibility | |
| • Outdoor sunscreen use | |
| • Photoallergy | |
| • Phototoxicity | |
| • Safety-in-use studies | |
| • Sensitivity (dermal injections) | |
| • Sensitization (HRIPT) |
| Claims Substantiation | |
| • Anti-cellulite | |
| • Anti-inflammatory activity | |
| • Anti-wrinkle | |
| • Cell turnover (exfoliation) | |
| • Comedogenicity | |
| • Latex and synthetic gloves | |
| • Mildness | |
| • Moisturization | |
| • Product Compatibility | |
| • Skin lightening | |
| • SPF |
| Topical Pharmaceutical Testing | |
| • Phase I first-in-man safety & patch studies | |
| • Phase II - IV testing for a variety of dermatologic indications |
Human
Topical Pharmacokinetic Studies
Once the in vitro pharmacokinetic characteristics of a topical formulation
have been defined, our expert staff will help you progress smoothly into
in vivo Phase I pharmacokinetic and safety studies. We have over 20 years
of topical in vivo DPK expertise and a facility specifically designed
to accommodate topical Phase I studies. Reports are tailored for in-house
circulation or in FDA/ICH format for submission to the appropriate regulating
agency.
| We have experience in the following areas: | ||
| • First-in-Man | ||
| • Standard Phase I studies | ||
| • Proof-of-Delivery studies | ||
| • Customized in vivo study designs for: | ||
| - Collection of blood, urine, feces or exhaled air | ||
| - Surface wash recovery of unabsorbed product | ||
| - Tape stripping to recover stratum corneum content | ||
| - Biopsies to assess epidermal and dermal content | ||
| - Protection of dosing sites with and without occlusion | ||
| - Multiple dosing regimens from 2 hours to 21 or more days | ||
| - Monitoring of vitals and cardiac function (ECG and Holter) | ||
| - Differentiating adverse events associated with skin reactions vs. systemic reactions | ||
Bioequivalence
Studies
Bioequivalence studies are performed to compare generic formulations to
innovator lots or in comparing new formulations to innovators.
| We have experience in the following areas: | |
| • Vasoconstriction studies (custom or by FDA guidance) | |
| • DPK tape stripping | |
| • Trans-epidermal water loss studies | |
| • Blood / urine level studies | |
| • Biopsy and stratum corneum deposition studies |
Contact
us today to find out how we can keep your next clinical trial on track.
Copyright © 2007, PRACS Institute, Ltd.
