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A Slit Face Trial Using Micro-injections of Transparent Hyaluronic Acid Gel for Rejuvenation of the Cheek

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ClinicalTrials.gov Identifier: NCT02679924
Recruitment Status : Unknown
Verified February 2017 by Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff.
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2016
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Galderma
Information provided by (Responsible Party):
Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff

Tracking Information
First Submitted Date  ICMJE November 11, 2015
First Posted Date  ICMJE February 11, 2016
Last Update Posted Date March 1, 2017
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Change in Wrinkling and Elastosis [ Time Frame: month 6 ]
Efficacy will be determined based on the difference between blinded evaluator assessment of Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale between Baseline and Month 6.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Slit Face Trial Using Micro-injections of Transparent Hyaluronic Acid Gel for Rejuvenation of the Cheek
Official Title  ICMJE A Single Center, Prospective, Randomized, Sham Controlled, Double Blind, Split Face Trial Using Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek
Brief Summary Soft tissue augmentation with injectable hyaluronic acid (HA) is a well-established modality for the correction of facial volume loss, fat atrophy, fine lines, and wrinkles. HA is a glycosaminoglycan that is composed of repeating D-glucuronic acid and D-N-acetylglucosamine disaccharide units. Because HA is a natural and inert constituent of the dermis, it represents an ideal substance for soft tissue augmentation. Current FDA-approved HA fillers are typically utilized to either directly target specific cutaneous rhytids or to restore overall contours by placement into fat pads or along bony structures that have remodeled with age. Restylane® Silk is a transparent injectable HA gel that received FDA approval in June 2014 for use in the lips and peri-oral region. Its unique synthesis results in smaller and finer particles that demonstrate significant hygroscopic properties and give rise to the potential for unique applications. One such application concerns the concept of "skin boosting" whereby microaliquots of HA are placed into the skin to induce biophysical improvement in dermal characteristics (1). Using this technique, a recent split-body study by Streker et al. demonstrated significant aesthetic improvements in face, hands and décolletage (2). However, there have been no well-controlled studies with validated aesthetic outcomes utilizing Restylane® Silk in this fashion to date. Because of the unique combination of ultra-fine product and high water-attracting capability, the investigators hypothesize that microinjections of Restylane® Silk can be used in a grid-like injection pattern for rejuvenation of the aging cheek.
Detailed Description This is a single center, prospective, randomized, sham-controlled, double-blind, split-face trial using micro-injections of Restylane® Silk for correction of mid to low cheek fine lines and wrinkles. Twenty (20) subjects will be enrolled. Each subject will receive Restylane® Silk to a defined area of mid to low cheek in a randomized blinded fashion with the contralateral cheek treated by sham injection. The injections will be delivered intradermally 1mm in depth via multiple 0.02 cc microinjections distributed in a grid array pattern with 0.5 cm to 1 cm between each injection point over total treatment area. The sham injections will be administered in identical fashion and will consist of sterile normal saline. Following completion of injection treatment, manual massage will be applied to the full area to promote even distribution of the product. The maximum amount of Restylane Silk to be used per treatments session/per cheek for balancing treatment is1cc (not to exceed a total of 3cc) per treated patient. Three dimensional digital photography utilizing the Vectra 3D System (Canfield) will be utilized to document pre-treatment status, sites of injection, and post-treatment effect. Subjects will be followed up at 1 week, 2 week, 4 week, day 90, and day 180 time points. At the Day 180 time point, every subject will be given the option to receive touch up and balancing treatments to both cheeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Problem of Aging
Intervention  ICMJE
  • Device: Hyaluronic Acid filler
    The objective of this study is to determine the efficacy and safety of Restylane® Silk Hyaluronic Acid filler microinjections when used in a grid-like injection pattern for the correction of fine lines to the cheeks.
    Other Name: Restylane Silk
  • Other: Sham Comparator
    Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles.
    Other Name: Normal Saline
Study Arms  ICMJE
  • Experimental: Restylane Silk
    Micro-injections of Restylane® Silk Hyaluronic Acid filler for correction of mid to low cheek fine lines and wrinkles.
    Intervention: Device: Hyaluronic Acid filler
  • Sham Comparator: Sham Comparator
    Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles.
    Intervention: Other: Sham Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female in general good health age 18 or over.
  • Mild to moderate static rhytids involving at least a 9 cm2 area of the mid to low cheeks.
  • Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
  • Must be willing to comply with study dosing and complete the entire course of the study.
  • Female patients will be either of non-childbearing potential defined as:

    1. Having no uterus
    2. No menses for at least 12 months
    3. Bilateral tubal ligation Or;

(WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:

  1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
  2. Intrauterine coil
  3. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
  4. Abstinence (If practicing abstinence must agree to use barrier method described above (3) if becomes sexually active).
  5. Vasectomized partner (must agree to use barrier method described above (3) if becomes sexually active with un-vasectomized).

    • Negative urine pregnancy test results Baseline prior to study entry (if applicable)

Exclusion Criteria:

  • Pregnant, planning pregnancy during the course of the study or breastfeeding
  • Severe static rhytids to the mid to low cheeks
  • Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
  • Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
  • Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
  • Use of oral/topical retinoids within 1 month of Baseline
  • Previous use of botulinum toxins in the treatment area within the past 6 months
  • Previous surgical procedure in the treatment area within the past 12 months
  • Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
  • History of non-compliance with clinical research protocols
  • Ablative laser resurfacing to on their face within 12 months
  • Non-ablative laser or light procedures to their face within the past 3 months
  • Known allergy to Restylane® Silk or any of its constituents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679924
Other Study ID Numbers  ICMJE RS-2015-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff
Study Sponsor  ICMJE Isabella Guiha
Collaborators  ICMJE Galderma
Investigators  ICMJE
Principal Investigator: Mitchel P Goldman, MD DCLA
PRS Account Goldman, Butterwick, Fitzpatrick and Groff
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP