Restylane Silk for Treatment of Chest Wrinkles

NCT03324997 | Withdrawn Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: GCO 16-2676
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline and 6 months

• Incidence of reported treatment emergent adverse events

  The incidence of reported treatment emergent adverse events

  up to 360 days

Secondary Outcomes (6)

• Change in dermal thickness

  Baseline and 6 months

• Change in papillary dermal brightness

  Baseline and 6 months

• Change in upper dermal reflectivity

  Baseline and 6 months

• Change in dermoepidermal contrast

  Baseline and 6 months

• Change in surface contouring

  Baseline and 6 months

Study Arms (2)

Restylane

EXPERIMENTAL

half the chest to be treated with Restylane Silk

Drug: Restylane Silk; Device: Optical Coherence Tomography

Placebo

PLACEBO COMPARATOR

half-chest injections with saline as a placebo to Restylane Silk.

Drug: Saline; Device: Optical Coherence Tomography

Interventions

Restylane Silk DRUG

Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.

Restylane

Saline DRUG

Saline as placebo

Placebo

Optical Coherence Tomography DEVICE

An FDA-cleared non-invasive imaging device

Also known as: OCT

Placebo; Restylane

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidi Waldorf: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Heidi Waldorf, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Giselle Singer

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: January 28, 2018
• Primary Completion: January 28, 2018
• Study Completion: January 28, 2018
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

US (1)