What is a clinical trial?
Cosmetic products can only fulfill their role because their claim has been carefully studied and their efficacy and tolerability have been properly established.
You will be using a dermo cosmetic product under medical control
What are Good Clinical Practices (GCP)?
Good Clinical Practices (GCP) are ethical and internationally recognized quality requirements, to be applied from the conception to the completion of trials in which volunteers are involved
How my child can participate in a clinical trial?
For minors, the consent of the legal representatives is essential. Authorisation to participate in a research study must be given by both parents. In cases where one parent cannot come to the center to give consent for participation, a proxy form must be signed by the absent parent.
Can I participate in several clinical trials at the same time?
No, for ethical and safety reasons, a volunteer cannot participate in more than one trial at the same time.
As a volunteer, am I compensated?
Volunteers participating in a clinical trial may be compensated. This compensation covers the constraints related to the trial (availability, travel costs, number of evaluations at the center, etc.).
The amount of compensation varies depending on the complexity of the study.
In the case of minor volunteers, compensation is paid to parents / holders of parental authority
Once I get into a clinical trial can I stop?
Anyone who has given their consent to participate in a study can change his mind AT ANY TIME, AND WITHOUT JUSTIFYING.
– The trial staff will discuss with you to understand your decision and try to reassure if necessary, but cannot in any case force you to maintain your participation.
– Also, the doctor may decide to stop your participation if he considers that the benefit / risk ratio is no longer positive
– Your health is ALWAYS a priority over the clinical trial.
What is the Wash-Out Period
The success of a trial largely depends on strict compliance with all instructions provided in the information documents, including those concerning the use of the product.
How am I protected?
Clinical trials are conducted according to the principles of the Declaration of Helsinki and in compliance with local laws (for Mauritius, Clinical Trial Act 2011). We ensure the protection of volunteers by submitting the appropriate documents to regulatory authorities and independent ethics committees
The volunteers are used as guinea pigs?
Abuse of language related to the treatment of the clinical research subject by the mainstream media.
Unlike the guinea pig, the participant in a clinical trial is totally VOLUNTARY. He can withdraw from the test at any time.
Any research (on cosmetic or pharmaceutical product) must be done with respect for health, integrity and of the dignity of the person. Animal testing is also banned in more and more of country…
Where is my personal information stored?
Are there any risks if I participate in a clinical trial?
The tests are carried out for cosmetic products whose safety has been proven by a toxicologist. The probability of local reactions, however, cannot be excluded. Usually these reactions are limited to the area of application and disappear within a few days.
Volunteers benefit from 24/7 assistance by phone. In case of emergency, Call on 401 26 00