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

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.

Study Overview

• Status: Unknown
• Conditions: Wrinkles

• Study Type: Observational
• Enrollment (Anticipated): 13

Contacts and Locations

• Study Contact: Name: Karina Brazdys, RN; Phone Number: 109 858-657-1002; Email: kbrazdys@gbk.com
• Study Contact Backup: Name: Donna Perez; Phone Number: 120 858-657-1002; Email: dperez@gbkderm.com

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92121
      • Recruiting
      • Goldman, Butterwick, Fitzpatrick and Groff
      • Contact: Donna Perez; Phone Number: 120 858-657-1002; Email: dperez@gbkderm.com
      • Contact: Karina Brazdys, RN; Phone Number: 109 858-657-1002; Email: kbrazdys@gbkderm.com
      • Principal Investigator: Mitchell P. Goldman, MD
    • San Francisco, California, United States, 94115
      • Recruiting
      • The Maas Clinic
      • Contact: Emily Shamban; Phone Number: 415-567-7000; Email: research@maasclinic.com
      • Principal Investigator: Corey Mass, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cosmetic Dermatology Practice Patients

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Mentor Worldwide, LLC
• Investigators: Principal Investigator: Mitchell P Goldman, MD, Dermatology and Cosmetic Laser Associated La Jolla

Study record dates

Study Major Dates

• Study Start: August 1, 2010

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 27, 2010
• First Posted (Estimate): December 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 28, 2010
• Last Update Submitted That Met QC Criteria: December 27, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: superficial vertical perioral lines; superficial horizontal and lateral canthal lines; correct moderate to severe facial wrinkles and folds
• Other Study ID Numbers: PRV-2010