Problem of AgingNCT02679924
A Slit Face Trial Using Micro-injections of Transparent Hyaluronic Acid Gel for Rejuvenation of the Cheek
A study testing Hyaluronic Acid filler in people with Problem of Aging, run by Isabella Guiha at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem of Aging
- What is being tested?
- Hyaluronic Acid filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Having no uterus
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- 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).
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Cosmetic Laser Medical Associates of La JOlla, Inc.
San Diego, California, 92121
About this study
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
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.
Read the 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.
- Conditions
- Problem of Aging
- Being tested
- Hyaluronic Acid filler, Sham Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid fillerDevice
Also called Restylane Silk
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.
Sham ComparatorOther
Also called Normal Saline
Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Silk | Experimental | Micro-injections of Restylane® Silk Hyaluronic Acid filler for correction of mid to low cheek fine lines and wrinkles. Receives: Device: Hyaluronic Acid filler |
| Sham Comparator | Sham comparator | Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles. Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrinkling and Elastosis
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.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem of AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabella Guiha
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor-investigator, Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff
- Investigators
- Mitchel P Goldman, MD, Principal investigator, DCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679924
- Sponsor's protocol ID
- RS-2015-01
- Status last verified
- Feb 2017
- First submitted
- 11 Nov 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02679924
- Acronym / sponsor ID
- RS-2015-01
- Conditions
- Problem of Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Isabella GuihaUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Nov 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Silk | Experimental | Device: Hyaluronic Acid fillerMicro-injections of Restylane® Silk Hyaluronic Acid filler for correction of mid to low cheek fine lines and wrinkles. |
| Sham Comparator | Sham comparator | Other: Sham ComparatorMicro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid fillerAlso: Restylane SilkThe 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. | Device | Restylane Silk |
| Sham ComparatorAlso: Normal SalineMicro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles. | Other | Sham Comparator |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel P Goldman, MD principal investigator
DCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid filler in people with Problem of Aging, run by Isabella Guiha at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wrinkling and Elastosis (time frame: month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.