A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic… (NCT01267149) | Clinical Trial Compass
UnknownNot Applicable
A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
United States13 participantsStarted 2010-08
Plain-language summary
Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines in the treated areas as compared to baseline.
Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas as compared to baseline.
Who can participate
Age range35 Years – 65 Years
SexALL
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Inclusion Criteria:
* Females and males in good general health between 35 to 65 years of age.
* Must be willing to give and sign a HIPPA form, informed consent form and a photographic release form
* Patient is planning to undergo Prevelle Silk treatment
* A potential subject's must exhibit:
A. moderate to severe superficial, vertical perioral and horizontal canthus lines
* For FEMALE PATIENT OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study \[i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active\]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
* Negative urine pregnancy test results at the time of study entry (if applicable)
* Must be willing to comply with study regimen and complete the entire course of the study.
Exclusion Criteria:
* A patient with any UNCONTROLLED systemic disease. A potential patient in whom therapy for a systemic disease is not yet stab…