Upper Facial Remodeling With Perlane-L and Dysport (NCT01354743) | Clinical Trial Compass
CompletedPhase 4
Upper Facial Remodeling With Perlane-L and Dysport
United States20 participantsStarted 2010-12
Plain-language summary
The purpose of this study is to provide data to support combination treatment of the upper face with Perlane-L® and Dysport™. This study will assess the outcome of upper face rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also be assessed as a secondary endpoint.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion Criteria:
* Outpatient,male or female subjects of any race, 40-75 years of age.
* Mild to Moderate temoral atrophy of (1 or 2 on Four Point Temporal Atrophy Scale)
* One of the following:
Periocular rhytids characterized by a measurement of 3 or more during maximum attempted muscle contraction (during maximum smiling) upon evaluation using the Rao-Goldman 5 point Facial Wrinkle Scale.
Mild to moderate glabella rhytiuds by a measurment of 3 or more upon evaluation using the Rao-Goldman 5-point Facial Wrinkle Scale.
* Subjects will be enrolled if previous history of facial cold sores, but will be medicated to avoid any recurrence.
* able to understand the requirements of the study and sign a Institutional Review Board Informed Consent/HIPPA Authorization forms and receive a copy.
* Subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study: A female is considered of childbearing potential unless she is post menopausal for \>12 months prior to study drug administration.
* without a uterus and/or both ovaries; or
* surgically sterile (e.g., tubal ligation) for \>6 months prior to study drug administration.
The following methods of contraception, if properly used, are generally considered reliable for females of childbearing potential who may participate in the study:
* hormonal contraceptives†(oral, patch, injection, implant);
* male condom with intra-vaginal…