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
Status: | Recruiting |
---|---|
Conditions: | Cosmetic |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 35 - 65 |
Updated: | 4/2/2016 |
Start Date: | August 2010 |
Contact: | Karina Brazdys, RN |
Email: | kbrazdys@gbk.com |
Phone: | 858-657-1002 |
Phase 4 Study - 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
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.
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.
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 stabilized will not be considered for entry into
the study
- A patient with a significant history or current evidence of a medical, psychological
or other disorder that, in the investigator's opinion, would preclude enrollment into
the study.
- A patient with a known hypersensitivity to any of the components of the study
medications
- A patient who is actively smoking or plans to smoke at any time of the duration of
this study
- A patient with an active skin condition/disease that might interfere with the
diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema,
psoriasis, seborrheic dermatitis, herpes labialis)
- A patient planning any other cosmetic procedure to their facial area during the study
period, other than the treatments that will be performed by the investigator
- A patient using any topical (prescription or over the counter) medicated creams,
lotions, gels, balms, powders, etc. on the treatment areas during the study period
- A patient receiving any topical products containing alpha-hydroxy acids, salicylic
acid, and vitamins C or D (includes derivatives thereof) on the perioral or lateral
canthal areas within 7 days prior to or during the study period, other than the study
products
- A patient receiving any investigational drug and/or has had a microdermabrasion
(light or medium skin peel) treatment on their perioral or lateral canthal areas
within 30 days prior to or during the study period
- A patient using any topical tretinoin product or derivative on their perioral or
lateral canthal areas within 12 weeks prior to or during the study period
- A patient receiving a chemical peel, any systemic steroids, a non-ablative laser,
light or radio frequency treatment and/or has had a Dermabrasion (deep skin peel) or
ablative laser treatments on their perioral or lateral canthal areas must have
discontinued the drug/treatment and/or had the procedure at least 6 months prior to
entering the study
- A patient that has previously been treated with botulinum toxin in the perioral or
lateral canthal areas within the past six months
- A patient that has previously been treated with dermal filler in the perioral or
lateral canthal areas within the past year
- A patient that with a history of allergic reaction to a dermal filler or lidocaine
- A patient that with a history of a permanent filler to the perioral or lateral
canthal areas
- A female patient who is pregnant, nursing an infant or planning a pregnancy during
the study [throughout the course of the study, women of child-bearing potential must
use reliable forms of contraception (i.e., oral contraceptive, intrauterine device,
abstinence, or spermicides and condoms used in combination)]
- Current participation or participation within 30 days prior to the start of this
study in a drug or other investigational research study.
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