The BioSil® Clinical Trials
Proven Results, Statistically Significant
Researchers used the gold standard of clinical trial protocols, randomized, double-blind, placebo-controlled, parallel group. This is the same protocol that the US government requires the pharmaceutical companies to use. It ensures accuracy and repeatable results.
For skin and nails, participants were all healthy women in their 40’s, 50’s and 60’s who showed clear signs of sun-damaged skin on top of natural-aged skin. That meant skin wrinkles, sagging skin, and loss of skin elasticity caused by decreased collagen, a degraded collagen “mesh” and degraded elastin. These women were chosen because over time the changes caused by the sun would occur naturally. For hair, the participants were all women between the ages of 18 and 65 who all showed signs of weak, thinning, dull hair. The large cross section of ages eliminated the possibility of strictly age-related thinning.
All results in the BioSil clinical trials are considered statistically significant (p<.05). “Statistical significance” means that the results obtained have come from the compound tested (in this case BioSil’s patented ch-OSA®). This reduces any possibility of “chance” to a great extent. BioSil is clinically proven to:
- Reduce fine line and wrinkles by 30.0%*
- Increase skin elasticity by 89.0%*
- Strengthen hair by 13.1%§
- Thicken hair by 12.8%§
- Dramatically strengthen nails (see VAS Scores in “Clinical Trials”)*
§ After 36 weeks versus the placebo group.
PLEASE NOTE: All BioSil results are clinically proven. Often times, you see products making the claim “clinically tested” or “clinically studied.” This says nothing about the results, which could have shown no improvement at all.
The Published Graphs From Peer-Reviewed Medical Journals
BioSil Results in Peer-Reviewed Medical Journals. See the Proof You’re Looking For.
Here’s your proof that BioSil does exactly what it claims to do. That is, reduce fine lines and wrinkles by 30%, thicken and strengthen hair by 13%, increase skin elasticity 89% and dramatically strengthen nails. These statistically significant results of these double-blind, placebo-controlled, randomized clinical trials have been peer-reviewed and published in leading medical journals.
Keep in mind, you see products making the claim “clinically tested” or “clinically studied.” Remember, this type of claim says nothing about the results, which could have shown no improvement at all. Of the products that do make the claim “clinically proven,” very few can say the clinical study used the randomized, double-blind, placebo-controlled protocol (the type of study required by the U.S. government for all pharmaceuticals). Even fewer can make the qualifying claim “statistically significant” – meaning the results are reliable and caused by ch-OSA itself. Of those that can say “statistically significant,” even fewer (if any) can say the results have been reviewed by peers in the medical community and been published in bona fide medical journals. But BioSil can say all that, and much more! That’s your proof that BioSil delivers what it promises.
Clinical Trial Protocols – Courtesy of Statistical Consultancy Team
When running a clinical trial the industry standard is a double-blind, placebo-controlled, parallel group trial. This is because it is the best way to ensure that the characteristics of subjects in each treatment group are the same, whilst ensuring the investigators cannot anticipate the treatment of a subject. An integral part of the study, ensuring the success of the trial and the integrity of the results is the randomization of subjects into the trial. Randomization ensures that every patient entering a trial has an equal chance of receiving the active treatment. This minimizes potential bias that could be introduced into the clinical trial.
There are several factors that need to be taken into account when conducting randomization in clinical trials. All current documentation (e.g. protocol, protocol amendments) for the trial should be provided by the primary investigator. It is important to establish the requirements for the randomization at an early stage and develop a specification document to detail the format that the randomization will take. This allows the primary investigator to see the format that the randomization will take without un-blinding them to the final randomization schedule.
The following must be clearly defined, documented and agreed with the primary investigator prior to the randomization being produced:
- Proportion of subjects to be allocated to each treatment group
- Stratification factors to be considered
- Block size to use
- Number of centers
- What outputs are required (e.g. schedule, randomization envelopes)
- The format any outputs will take
Regular communication between the sponsor and the investigator will help ensure the correct information is collected. Then the randomization information is sent to the correct places to ensure there is no accidental un-blinding.
The team producing the randomization must not be involved in the reporting of the study as they will be un-blinded to the treatment allocation and could cause bias in the results. A dummy randomization may be produced to show the investigator the exact format and layout that the final outputs will take – these must clearly be labelled as draft to ensure there is no confusion with the final randomization.
Print randomization envelopes may also be produced to un-blind study personnel in an emergency to the treatment allocation of a particular subject, for example, a subject may be experiencing a serious adverse event (SAE), and it is critical to find out what treatment they have received. Randomization envelopes allow un-blinding of an individual subject, without having to un-blind the entire study which could cost the sponsor significant amounts of money and time invested in the clinical trial.
Once a randomization has been produced and sent to the relevant staff as detailed in the specification document it is important to store the randomization correctly to ensure that no study staff can accidentally be un-blinded to the treatment allocations. No information can be stored on computer networks. All randomization information should be stored in a secure facility which has limited access only for certain un-blinded staff members. For example, fireproof cabinets are used and controlled access with records of which statisticians are allowed access to the keys to these secure facilities.
Randomizations conducted correctly help to ensure the success of the trial and the integrity of the results. If the randomization of a clinical trial was to be performed incorrectly it could result in introducing bias into the study results and potentially the use of incorrect methodology.