Brow Lifting With Dysport (NCT01401803) | Clinical Trial Compass
CompletedPhase 4
Brow Lifting With Dysport
United States24 participantsStarted 2011-09
Plain-language summary
The purpose of this study is to provide data to assess Dysport™ injections as a treatment therapy for brow ptosis. This study will assess the outcome of brow lifting with use of Dysport.
Who can participate
Age range25 Years – 75 Years
SexALL
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Inclusion Criteria:
* Healthy male or female subjects of any race, 25-75 years of age
* Mild to Moderate brow ptosis (2 or 3 on a 5-point Brow Positioning Grading Scale)
* Subject has signed the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
* Subject is able to follow study instructions and likely to complete all required visits, as assessed by the Treating Investigator
* Subject has had a urine pregnancy test evaluated as negative\* within 7 days prior to planned study treatment, has used contraception for at least a month prior to planned study treatment, and agrees to use contraception for the duration of the study
* 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:
* postmenopausal 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 spermicide or diaphragm or cervi…