WrinkleNCT03742479
Restylane Silk Microinjections to Cheeks
A study testing Restylane® Silk in people with Wrinkle, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Restylane® Silk
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to Feb 2020
- 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
- Symmetrical visible sign of aging 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. 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
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- Intrauterine coil
- Bilateral tubal ligation
- 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 (4) if becomes sexually active).
- Vasectomized partner (must agree to use barrier method described above (4) 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
- Extremely Severe aging face with extensive photodamage
- 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, 1 recruiting
- Recruiting
West Dermatology Research Center
San Diego, California, 92121
Kristi Cobb, 858-657-1004 ext. 139, KCobb@CLDerm.com
Isabella Guiha, 858 657 1004 ext. 119, IGuiha@CLDerm.com
About this study
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
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.
Read the 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.
- Conditions
- Wrinkle
- Being tested
- Restylane® Silk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane® SilkDevice
Injectable Hyaluronic Acid (HA)
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Microinjection | Experimental | Not described Receives: Device: Restylane® Silk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator five point global aesthetic improvement score
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
Measured: Baseline to 6 - Months Post Final Treatment
Cutometer Measured Skin Elaticity
Change in elasticity from baseline to the last visit measured using a Cutometer
Measured: Baseline to 6 - Months Post Final Treatment
Hydrometer measured Transepidermal Water Loss
Change in transepidermal waterloss from baseline to the last visit measured using a hydrometer.
Measured: Baseline to 6 - Months Post Final Treatment
Secondary outcomes (1)
Safety - Injection Site Adverse Events
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.
Measured: Baseline to 6 - Months Post Final Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start26 Feb 2019
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group, Open Label Study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Guiha, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742479
- Sponsor's protocol ID
- Silkcheek-2018-01
- Status last verified
- May 2019
- First submitted
- 8 Nov 2018
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03742479
- Acronym / sponsor ID
- Silkcheek-2018-01
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 15 Nov 2018 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group, Open Label Study
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Microinjection | Experimental | Device: Restylane® Silk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Symmetrical visible sign of aging 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. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
Key exclusion criteria (14 listed)
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 |
|---|---|---|
| Restylane® SilkInjectable Hyaluronic Acid (HA) | Device | Hyaluronic Acid Microinjection |
Primary outcome
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
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
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.
1 secondary outcome
Safety - Injection Site Adverse Events
Time frame: Baseline to 6 - Months Post Final Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane® Silk in people with Wrinkle, run by Goldman, Butterwick, Fitzpatrick and Groff 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 12 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 3 May 2019. 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. 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?
Contact Shannon Quigley (858 657 1004 ext. 141, SQuigley@CLDerm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator five point global aesthetic improvement score (time frame: Baseline to 6 - Months Post Final Treatment). The study lists 3 primary outcomes in all. 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 3 May 2019.