What is a clinical study?
Clinical trials are research studies that explore whether a treatment or device is safe and/or effective for humans. The purpose of clinical trials is research, so they follow strict scientific standards. These standards ensure the protection of test subjects and the production of reliable study results.
Why would I need a clinical study?
Studies conducted at Evalulab will provide you the tools to:
- Target a market segment effectively
- Highlight product benefits with confidence
- Enhance product image
- Gain customer loyalty
- Build a solid foundation for long-term growth
- Minimize product returns.
Why would I need Evalulab?
Evalulab is your clinical lab partner. Evalulab’s team is committed to provide you the highest quality of clinical studies services. Evalulab has built a trust relationship with its clients and business partners by adhering to a professional code based on the following principles:
- Constant involvement in the industry
- Continuous improvement of the quality system
- Respect of ethics and confidentiality
- Respect of project objectives and deadlines
- Transparency and clarity of communications.
PRODUCTS THAT CAN BE TESTED
Products applied to the skin can be classified into several categories. The classification varies according to each country’s regulations. However, in general, products may be classified into three main categories:
Cosmetics, also called beauty, make-up or personal care products are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FDA definition for cosmetic products).
Cosmeceuticals are products applied to the skin (creams, lotions, ointments or gels) that contain biologically active ingredients believed to have medical effects or benefits similar to drugs. Products that are orally administered and have benefits perceived on the skin are known as nutraceuticals.
Some products may have cosmetics-like characteristics but are also classified as drugs or OTC products. These products include, for example, anti-acne products, antiperspirants, anti-dandruff shampoos, medicated topical products, products for diaper rash, topical antiseptic cleansers, sunscreens (protection against sunburn) and some skin lightening products.
The development of a new product is a long path full of pitfalls. Before the commercialization, clinical tests are usually carried on by an independent laboratory (or in-house when facilities allow it) to learn more about the product’s characteristics. When the results of analyses, stability tests, toxicology tests, safety tests, etc. are acquired, the product can be tested on humans via clinical studies.
A clinical trial aims to prove or to review the product’s effects to determine the performance claims later. Therefore, it confirms all the attributes on the marketing support (labels, packaging, catalogues, advertisements, companies’ websites and social media).
It is important for the company to be honest and consistent especially on everything that is presented explicitly and implicitly on their products.
Clinical tests especially efficacy studies allow to objectively check or confirm the performance of a given product with specific instruments and scientific techniques.
The main goal of this type of study is to determine the performance of a product developed by a sponsor (for example, a cream) for a given claim. In order to obtain better quantitative values, the clinical study development evaluates the efficacy of a product by measuring different predetermined criteria and using scientific methods.
Note that the second objective of a clinical study is to assess the tolerance of the product to be tested, under normal and foreseeable conditions of use.
Evalulab offers clinical tests, standard or personalized (customized), to evaluate the performance of cosmetics, personal care products, medical devices, over-the-counter (OTC) drugs or natural products.
A performance claim
A performance claim is a concise statement describing the tested product’s performance for a specific parameter under precise study conditions.
According to the laws and regulations of the country where your product is sold, the allegation should respect the rules which can slightly be different. However, a consensus is generally reached when a claim should be true and supported by proofs.
For example, in Canada, the “Guidelines for Cosmetic Advertising and Labelling Claims” are published by Health Canada and guide the manufacturers in the process of claims.
In the United States, the Federal Trade Commission has the purpose to prevent the anti-competitive, misleading or unfair business practices for consumers.
Europe also has its office of claims under the European Commission which requires that every cosmetic manufacturer holds an accessible record with proofs of allegations done on their products (see Règlement EU No 655/2013 published in July 2013).