CLINICAL STUDIES FOR PHARMACEUTICAL, COSMETIC AND LASER COMPANIES:
Features
PROVEN VALIDITY
Publication in peer-reviewed medical journals is the gold standard of clinical study validity, and we have over 75 published or presented studies in dermatology journals and conventions around the world.
WHAT WE DO
Study Types:
Determines the efficacy or likelihood of a product to cause an adverse reaction and to determine the organoleptic and aesthetic characteristics of the investigated product subsequent to its use and to gather consumer feedback regarding the product.
This procedure determines the specific substance or ingredient, called allergen, that is causing contact dermatitis on the skin and whether this is an allergic or irritant reaction. Patch testing for allergens can be done by either of the following: HRIPT/RIPT (Human Repeat Insult Patch Testing), ROAT (Repeat Open Application Testing), SOPT (Standard Occlusive Patch Testing) with multiple subjects.
Testing for the potential of a cosmetic product or of its components to form acne-like clogged hair follicles called comedones (whitehead/blackheads) by various methods such as follicular cyanoacrylate biopsy with analysis by epiluminescence microscopy.
Sunscreens work by reflecting/absorbing UV Radiation (ultraviolet radiation/visible light). Studies to determine the protection factor of sunscreen products (oral/ topical) vs. a control to enhance ultraviolet/visible light/infrared radiation protection studies are done to measure the ability of a sunscreen to delay skin reaction induced by solar radiation. Can be done in-vitro with the use of a spectrophotometer.
Long term/short term* – studies where investigational medical products are given to randomized patients. Particular dermatological diseases are studied by the team consisting of a Principal Investigator, Sub-investigator, study coordinator, research nurse and unblinded staff. *May vary depending on the phase the proposed study is in. (e.g Phase 1, 2, 3 etc)
Analyses can be done in vitro (controlled environment) or in vivo (living organisms). Can be done in combination with sunscreen protection determination.
Subjects are assigned randomly in different groups to receive one of the several clinical interventions. These clinical studies are customized according to a company’s product claim.
Studies for sensitivity to outdoor/indoor UV, plant-antioxidants, microbiota, anti-inflammatory diets, Biologics and on the use of Virgin Coconut Oils.
Gather additional information about a product’s safety, efficacy, or optimal use. Products are then observed for adverse drug reactions or ADRs.*
An ADR is defined by the World Health Organization (WHO) as: ‘a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function’
MEDICAL CLINIC:
Unlike a pure laboratory setting, VSRC is also a full dermatological clinic. In addition to patient volume, our innovative, ethical care leads to stronger, more creative research with real-world applications. VSRC offers either the full-blanket of clinical research testing or contracts for specific purposes.
