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

Goldman, Butterwick, Fitzpatrick and Groff

Status: Unknown

Conditions: Wrinkles

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01267149

PRV-2010

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.