Product Development: Three Critical Steps To An Effective Product
The Therametics Method
Therametics scientists approach product development in a completely different way than other skincare companies. Our scientists use state of the art techniques in cellular and molecular biology to develop products with revolutionary skincare properties. At every stage of development we test our products to ensure that they are both safe and effective. The scientists at Therametics follow a multi-phase approach to develop novel active skincare therapeutics.
Phase 1: Bioactive Compound Identification and Characterization (Therascreen) Therametics scientists use an in vitro cell culture model and the most advanced procedures in molecular biology to screen and identify compounds that alter skin cell function in a positive way. All Therametics bioactive compounds originate from discoveries by Therametics scientists in the company R&D laboratory. Candidate compounds are evaluated for therapeutic activity using a multi-step screening program designed to determine: The skin cell types affected by the compound.
The specific molecular and cellular processes in each cell type that is regulated by the compound.
The optimal concentration of each compound that is required to regulate skin cell function.
Further information regarding how Therametics scientists identify and characterize bioactive compounds is provided as follows: Bioactive Compound Identification and Characterization.
Phase 2: Development of Topical Formulations that Deliver Bioactive Compounds into the Skin Even though a bioactive is effective in cell culture models, the incorporation of a bioactive into a topical formulation will only work if the compound penetrates the tough outer layer of skin to reach the target cells located deep within the skin. Therametics scientists use a scientific approach to formulation development in order to design formulations that:
Deliver precise amounts of each bioactive compound past the tough outer surface layer of skin down into the target cells.
Provide a time-released supply of bioactive to the target cells for 12 hours following a single application.
The delivery of bioactives through the skin by these formulations is verified by laboratory tests that use actual human skin. Due to Therametics rigorous approach to formulation development, Therametics formulations used twice daily guarantee that target skin cells are continuously exposed to bioactive, which further accelerates the healing process. Further information regarding how Therametics scientists determine the amount of bioactive that is delivered through the skin is provided as follows: Franz Cell Analysis.
Phase 3: Toxicology Testing to Determine Safety of Product
Therametics is committed to carrying out comprehensive studies to ensure the safety of our products. All of our products are subjected to a rigorous toxicology testing program similar to that required by the FDA for prescription drugs. While such tests are expensive, it is necessary to ensure that the bioactive molecules incorporated into our skincare products are completely safe. The toxicology studies include genetic analysis, skin and eye irritation, skin sensitization, and long-term repeated dose blood and tissue analysis.
Phase 4: Clinical Studies to Determine Product Efficacy
After a product has passed safety testing, it is subjected to independent, blinded, vehicle-controlled clinical studies to determine its efficacy in treating a particular skin problem or dermatological disease. Therametics conducts clinical studies using the same standards that are required by the FDA for prescription drugs. These studies require that two groups of patients are enrolled. One group is treated with the "active" product while another group is treated with a product that does not contain the "active" ingredient (the "control" group). To ensure complete objectivity, both the clinical investigator and the patient are "blinded", i.e. neither one knows if the patient is using the "control" product or the "active" product. For each study, the physician investigator uses a large number of clinical criteria to measure changes in the condition of the skin. Data are then analyzed using advanced biostatistics to make sure the results are significant and can be properly attributed to our product.