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Restylane Silk Microinjections to Cheeks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742479
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Isabella Guiha, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Brief Summary:
The objective of this study is to determine the efficacy and safety of Restylane® Silk microinjections when used in a grid-like injection pattern for the correction of fine lines to the cheeks.

Condition or disease Intervention/treatment Phase
Wrinkle Device: Restylane® Silk Not Applicable

Detailed Description:
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 the entire cheeks. The defined area will be defined as the following: line extending from the upper margin of the nasal ala to the upper margin of the tragus, from the tragus to 1 cm above the mandibular angle, from 1 cm above the mandibular angle to 1 cm above the pre-jowl sulcus, and from 1 cm above the pre-jowl sulcus to the upper margin of the nasal ala. The injections will be delivered intradermally via multiple 0.02 cc microinjections distributed in a grid array pattern with 1-2 cm between each injection point (see figure 1; injections will extend 1 cm above the illustration). Following completion of injection treatment, manual massage will be applied to the full area to promote even distribution of the product. Each subject will undergo a total of three treatment sessions, one month apart, day 1, week 4, and week 8. The maximum amount of Restylane to be used per treatments session/per cheek is 1.5cc (not to exceed a total of 9 cc) 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 4 weeks, 8 weeks, post-treatment day 90, and day 180. Objective measures of efficacy will be me performed pre-treatment, at day 90 and 180.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group, Open Label Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Prospective, Open-label, Clinical Trial Using Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyaluronic Acid Microinjection Device: Restylane® Silk
Injectable Hyaluronic Acid (HA)




Primary Outcome Measures :
  1. Investigator five point global aesthetic improvement score [ Time Frame: Baseline to 6 - Months Post Final Treatment ]
    Change in Investigator five point global aesthetic improvement score from Baseline at all follow up visits through month 6 using Investogator's Global Aesthetic Improvement Scale

  2. Cutometer Measured Skin Elaticity [ Time Frame: Baseline to 6 - Months Post Final Treatment ]
    Change in elasticity from baseline to the last visit measured using a Cutometer

  3. Hydrometer measured Transepidermal Water Loss [ Time Frame: Baseline to 6 - Months Post Final Treatment ]
    Change in transepidermal waterloss from baseline to the last visit measured using a hydrometer.


Secondary Outcome Measures :
  1. Safety - Injection Site Adverse Events [ Time Frame: Baseline to 6 - Months Post Final Treatment ]
    At each follow up visit, any adverse effects such as but not limited to bruising, erythema, swelling, pain, tenderness, itching, dysesthesia, and nodularity will be recorded descriptively.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

b. Symmetrical visible sign of aging involving at least a 9 cm2 area of the mid to low cheeks.

c. Must be willing to give and sign a HIPPA form, photo consent and informed consent form.

d. Must be willing to comply with study dosing and complete the entire course of the study.

e. Female patients will be either of non-childbearing potential defined as:

1. Having no uterus 2. No menses for at least 12 months. 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. Bilateral tubal ligation
  4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
  5. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
  6. Vasectomized partner (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized).

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

    Exclusion Criteria:

    1. Pregnant, planning pregnancy during the course of the study or breastfeeding
    2. Extremely Severe aging face with extensive photodamage
    3. Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
    4. Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
    5. Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
    6. Use of oral/topical retinoids within 1 month of Baseline
    7. Previous use of botulinum toxins in the treatment area within the past 6 months
    8. Previous surgical procedure in the treatment area within the past 12 months
    9. 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.
    10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
    11. History of non-compliance with clinical research protocols
    12. Ablative laser resurfacing to on their face within 12 months
    13. Non-ablative laser or light procedures to their face within the past 3 months
    14. Known allergy to Restylane® Silk or any of its constituents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742479


Contacts
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Contact: Shannon Quigley 858 657 1004 ext 141 SQuigley@CLDerm.com

Locations
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United States, California
West Dermatology Research Center Recruiting
San Diego, California, United States, 92121
Contact: Kristi Cobb    858-657-1004 ext 139    KCobb@CLDerm.com   
Contact: Isabella Guiha    858 657 1004 ext 119    IGuiha@CLDerm.com   
Principal Investigator: Mitchel P Goldman, MD         
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
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Responsible Party: Isabella Guiha, Certified Clinical Research Coordinator, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
ClinicalTrials.gov Identifier: NCT03742479    
Other Study ID Numbers: Silkcheek-2018-01
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes