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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Goldman, Butterwick, Fitzpatrick and Groff.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by:
Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier:
NCT01267149
First received: December 23, 2010
Last updated: December 27, 2010
Last verified: December 2010
  Purpose

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.


Condition
Wrinkles

Study Type: Observational
Official Title: 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

Further study details as provided by Goldman, Butterwick, Fitzpatrick and Groff:

Estimated Enrollment: 13
Study Start Date: August 2010
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cosmetic Dermatology Practice Patients

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267149

Contacts
Contact: Karina Brazdys, RN 858-657-1002 ext 109 kbrazdys@gbk.com
Contact: Donna Perez 858-657-1002 ext 120 dperez@gbkderm.com

Locations
United States, California
Goldman, Butterwick, Fitzpatrick and Groff Recruiting
La Jolla, California, United States, 92121
Contact: Karina Brazdys, RN    858-657-1002 ext 109    kbrazdys@gbkderm.com   
Contact: Donna Perez    858-657-1002 ext 120    dperez@gbkderm.com   
Principal Investigator: Mitchell P. Goldman, MD         
The Maas Clinic Recruiting
San Francisco, California, United States, 94115
Contact: Emily Shamban    415-567-7000    research@maasclinic.com   
Principal Investigator: Corey Mass, MD         
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
Mentor Worldwide, LLC
Investigators
Principal Investigator: Mitchell P Goldman, MD Dermatology and Cosmetic Laser Associated La Jolla
  More Information

No publications provided

Responsible Party: Mitchell Goldman MD, Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT01267149     History of Changes
Other Study ID Numbers: PRV-2010
Study First Received: December 23, 2010
Last Updated: December 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Goldman, Butterwick, Fitzpatrick and Groff:
superficial vertical perioral lines
superficial horizontal and lateral canthal lines
correct moderate to severe facial wrinkles and folds

ClinicalTrials.gov processed this record on October 21, 2014