WrinklePhase 2NCT03324997

Restylane Silk for Treatment of Chest Wrinkles

A Phase 2 study testing Restylane Silk, Saline and Optical Coherence Tomography in people with Wrinkle, run by Heidi Waldorf at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 25 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Wrinkle
What is being tested?: Restylane Silk, Saline and Optical Coherence Tomography
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 28 Jan 2018to 28 Jan 2018
Phase: Phase 2
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 25 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Wrinkle
Being tested: Restylane Silk, Saline, Optical Coherence Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restylane SilkDrug
Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.
SalineDrug
Saline as placebo
Optical Coherence TomographyDevice
Also called OCT
An FDA-cleared non-invasive imaging device

Study groups in NCT03324997
Study group	Role	What they receive
Restylane	Experimental	half the chest to be treated with Restylane Silk Receives: Drug: Restylane Silk; Device: Optical Coherence Tomography
Placebo	Placebo comparator	half-chest injections with saline as a placebo to Restylane Silk. Receives: Drug: Saline; Device: Optical Coherence Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Fabi-Bolton (FB) clinometric chest wrinkle scale
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).
Measured: Baseline and 6 months
Incidence of reported treatment emergent adverse events
The incidence of reported treatment emergent adverse events
Measured: up to 360 days

Secondary outcomes (6)

Change in dermal thickness
Achieving statistically significant changes in optical coherence tomography (OCT) (epidermal, papillary, and visible reticular dermal thickness) at 6 months after 3 treatment sessions given
Measured: Baseline and 6 months
Change in papillary dermal brightness
Achieving statistically significant changes in OCT parameters (papillary dermal brightness) at day 180 after 3 treatment sessions given
Measured: Baseline and 6 months
Change in upper dermal reflectivity
Achieving statistically significant changes in OCT parameters (upper dermal reflectivity) at day 180 after 3 treatment sessions given
Measured: Baseline and 6 months
Change in dermoepidermal contrast
Achieving statistically significant changes in OCT parameters (dermoepidermal contrast) at day 180 after 3 treatment sessions given
Measured: Baseline and 6 months
Change in surface contouring
Achieving statistically significant changes in OCT parameters (surface contouring) at day 180 after 3 treatment sessions given
Measured: Baseline and 6 months
Patient satisfaction
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 201828 Jan 2018

First posted30 Oct 2017
Study start28 Jan 2018 (estimated)
Primary completion28 Jan 2018
Study completion28 Jan 2018

Why it stopped: PI left institution

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03324997
Sponsor's protocol ID: GCO 16-2676
Status last verified: Mar 2018
First submitted: 25 Oct 2017
Last updated: 6 Mar 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03324997
Acronym / sponsor ID: GCO 16-2676
Conditions: Wrinkle
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: PI left institution
Enrolment: 0 participants (actual)
Lead sponsor: Heidi WaldorfUniversity, hospital or other
Study start: 28 Jan 2018 (estimated)
Primary completion: 28 Jan 2018 (actual)
Study completion: 28 Jan 2018 (actual)
First posted: 30 Oct 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Restylane	Experimental	Drug: Restylane Silk, Device: Optical Coherence Tomographyhalf the chest to be treated with Restylane Silk
Placebo	Placebo comparator	Drug: Saline, Device: Optical Coherence Tomographyhalf-chest injections with saline as a placebo to Restylane Silk.

Who may qualify

Ages: 25 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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.

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 SilkRestylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.	Drug	Restylane
SalineSaline as placebo	Drug	Placebo
Optical Coherence TomographyAlso: OCTAn FDA-cleared non-invasive imaging device	Device	Placebo, Restylane

Primary outcome

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).
Incidence of reported treatment emergent adverse events
Time frame: up to 360 days
The incidence of reported treatment emergent adverse events

6 secondary outcomes

Change in dermal thickness
Time frame: Baseline and 6 months
Change in papillary dermal brightness
Time frame: Baseline and 6 months
Change in upper dermal reflectivity
Time frame: Baseline and 6 months
Change in dermoepidermal contrast
Time frame: Baseline and 6 months
Change in surface contouring
Time frame: Baseline and 6 months
Patient satisfaction
Time frame: 6 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.

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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.

Heidi Waldorf, MD principal investigator

Icahn School of Medicine at Mount Sinai

Giselle Singer study director

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Restylane Silk, Saline and Optical Coherence Tomography in people with Wrinkle, run by Heidi Waldorf 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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 Mar 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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 Fabi-Bolton (FB) clinometric chest wrinkle scale (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03324997.

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 6 Mar 2018.