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
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Condition or disease | Intervention/treatment | Phase |
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Problem of Aging | Device: Hyaluronic Acid filler Other: Sham Comparator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2015 |
Estimated Primary Completion Date : | August 2017 |
Estimated Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
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Experimental: Restylane Silk
Micro-injections of Restylane® Silk Hyaluronic Acid filler for correction of mid to low cheek fine lines and wrinkles.
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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 |
Sham Comparator: Sham Comparator
Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles.
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Other: Sham Comparator
Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles.
Other Name: Normal Saline |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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Female patients will be either of non-childbearing potential defined as:
- Having no uterus
- No menses for at least 12 months
- 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:
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- Intrauterine coil
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (3) if becomes sexually active).
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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

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): NCT02679924
United States, California | |
Dermatology Cosmetic Laser Medical Associates of La JOlla, Inc. | |
San Diego, California, United States, 92121 |
Principal Investigator: | Mitchel P Goldman, MD | DCLA |
Responsible Party: | Isabella Guiha, Mitchel P. Goldman, MD (Principal Investigator), Goldman, Butterwick, Fitzpatrick and Groff |
ClinicalTrials.gov Identifier: | NCT02679924 |
Other Study ID Numbers: |
RS-2015-01 |
First Posted: | February 11, 2016 Key Record Dates |
Last Update Posted: | March 1, 2017 |
Last Verified: | February 2017 |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors |
Physiological Effects of Drugs Viscosupplements Protective Agents |