Restylane Silk for Treatment of Chest Wrinkles

March 2, 2018 updated by: Heidi Waldorf

Small Particle Hyaluronic Acid-Based Gel (Restylane Silk) for Treatment of Chest Wrinkles: A Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial of Efficacy and Safety

The purpose of this study is to assess the safety and efficacy of using Restylane Silk to reduce the appearance of photoaging on the chest. Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth. This study will compare the appearance of chest wrinkles on half the chest treated with Restylane Silk and the other half, which will be treated with placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Restylane Silk has been safely and effectively used in rejuvenation and appearance of wrinkles in the face. This study seeks to investigate the safety and efficacy of the injectable device in the chest for similar effects. Participants will undergo three treatments with Restylane Silk and results will be measured clinically and with Optical Coherence Tomography (an FDA-cleared non-invasive imaging device). Participants will receive randomized injections with the Restylane Silk product on half of the chest and will receive placebo injections on the other half. At the six-month period, participants will have the option to receive treatment with the product on the placebo side. At the 12-month period, participants may also elect for three additional touch-up treatments, which will not be counted as part of the study. If the chest is asymmetric in regards to wrinkles, the investigators will still proceed with the protocol because they are also comparing each side to itself prior to treatment, instead of simply comparing one side to the other.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients between the ages of 25-55 years.
  • Moderate photodamaged skin of the chest/décolletage, as per the Fabi-Bolton chest wrinkle scale
  • Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and able to comply with all study requirements including daily applications of the study product, and restrictions regarding concomitant medication and other treatments.
  • Female subject of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study product administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.

Exclusion Criteria:

  • History of keloid or hypertrophic scarring
  • History of allergy or hypersensitivity to injectable hyaluronic acid gel, lidocaine, local topical anesthetics or nerve blocking agents
  • Presence of any of the following at treatment sites: active inflammation/dermatitis, infection, psoriasis, herpes zoster, acanthosis, cancer, precancer, actinic keratosis
  • History of the use of any other rejuvenate treatment in the preceding eight months or plans to use these substances or have these procedures during the study (including but not limited to neuromodulators, soft tissue augmentation, fractional resurfacing, chemical peel, ultrasound)
  • The use of daily platelet inhibiting agents (i.e. Aspirin), anti-inflammatory medications, anticoagulants, Vitamin E, ginkgo biloba and other "herbs / homeopathic remedies" within 7 days of before or after treatment.
  • History of severe allergies or multiple allergies manifested by Premarket Approval (PMA) P040024/s072: FDA Summary of Safety and Effectiveness Data page 10 anaphylaxis or a history of a hypotensive crisis in response to radio-contrast media or other osmotic agent
  • Presence of any condition, which in the opinion of the investigator, would make the subject unable to complete the study per protocol
  • Current use of immunosuppressive therapy
  • History of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematous, polymyositis, dermatomyositis, or scleroderma;
  • Participation in any interventional clinical research study within 30 days prior to randomization.
  • Current smoker (or has quit smoking for less than 1 year)
  • Current active malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Restylane
half the chest to be treated with Restylane Silk
Drug: Restylane Silk
Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.
Device: Optical Coherence Tomography
An FDA-cleared non-invasive imaging device
Other Names:
  • OCT
PLACEBO_COMPARATOR: Placebo
half-chest injections with saline as a placebo to Restylane Silk.
Drug: Saline
Saline as placebo
Device: Optical Coherence Tomography
An FDA-cleared non-invasive imaging device
Other Names:
  • OCT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Fabi-Bolton (FB) clinometric chest wrinkle scale
Time Frame: Baseline and 6 months
The change from baseline in blinded evaluator assessments of chest/décolletage and 6 months assessed by the Fabi-Bolton (FB) chest wrinkle. The Fabi-Bolton (F-B) 5-point wrinkle scale (1 = wrinkles absent; 2 = shallow but visible wrinkles; 3 = moderately deep wrinkles; 4 = deep wrinkles, with well-defined edges; 5 = wrinkles very deep with redundant folds).
Baseline and 6 months
Incidence of reported treatment emergent adverse events
Time Frame: up to 360 days
The incidence of reported treatment emergent adverse events
up to 360 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in dermal thickness
Time Frame: Baseline and 6 months
Achieving statistically significant changes in optical coherence tomography (OCT) (epidermal, papillary, and visible reticular dermal thickness) at 6 months after 3 treatment sessions given
Baseline and 6 months
Change in papillary dermal brightness
Time Frame: Baseline and 6 months
Achieving statistically significant changes in OCT parameters (papillary dermal brightness) at day 180 after 3 treatment sessions given
Baseline and 6 months
Change in upper dermal reflectivity
Time Frame: Baseline and 6 months
Achieving statistically significant changes in OCT parameters (upper dermal reflectivity) at day 180 after 3 treatment sessions given
Baseline and 6 months
Change in dermoepidermal contrast
Time Frame: Baseline and 6 months
Achieving statistically significant changes in OCT parameters (dermoepidermal contrast) at day 180 after 3 treatment sessions given
Baseline and 6 months
Change in surface contouring
Time Frame: Baseline and 6 months
Achieving statistically significant changes in OCT parameters (surface contouring) at day 180 after 3 treatment sessions given
Baseline and 6 months
Patient satisfaction
Time Frame: 6 months
The questionnaire consists of two "Yes/No" questions (score 0 or 1) and five questions using a 5 point Likert rating scale with scores ranging from 0 (extremely dissatisfied) to 5 (extremely satisfied). The total score range is from 0-27.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heidi Waldorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heidi Waldorf, MD, Icahn School of Medicine at Mount Sinai
  • Study Director: Giselle Singer, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 16-2676

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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