Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum (NCT01728337) | Clinical Trial Compass
CompletedPhase 4
Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum
Brazil80 participantsStarted 2011-07
Plain-language summary
this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
* Female subjects;
* Phototype I to IV;
* Subjects aged between 18 and 60 years;
* Subjects naive for BT-A treatment;
* Subjects presenting the same degree of moderate (2) to severe (3) wrinkles on the left and right side of forehead under maximum voluntary contraction of the frontalis m. according WSS;
* Subjects with Minor's test showing at least grade III in the Sweating Intensity Visual Scale;
* Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
* Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
* Availability of the subject throughout the study (5 months);
* Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
* Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.
Exclusion Criteria:
* Pregnant women or women intending to become pregnant in the following 5 months after screening;
* Lactation period;
* Subjects participating in other clinical trials;
* Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharopl…
What they're measuring
1
Percentage of Responders After 5 Months After the Procedure