Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty

NCT04169308 | Completed Phase 1 FDA Drug

• 1 other identifier: RRFI-2019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine the effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life determined by using the FACE-Q Scale. Secondary objectives include: To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs. To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation. To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty.

Conditions

Deformity of Nasal Cartilage

Outcome Measures

Primary Outcomes (1)

• To determine the effects of Restylane-L® Filler injection into the nose on first impressions and quality of life based on the validated questionnaires using FACE-Q scales.

  We will measure changes in first impressions using a questionnaire with categories which include social skills, academic performance, dating success, occupational success, attractiveness, financial success, relationship success, and athletic skills. The 300 independent reviewers will grade each photo on a scale of 1(least favorable) to 10 (best). Evaluation of effects on quality of life will be reported through comparison of pre/post injection quality of life survey scores filled out by patients using the validated FACE-Q PRO survey measure (categories include appraisal of nasal appearance, psychological well-being, social function, and psychological distress). Maximal reported score is 4 (very satisfied) and lowest reported score is 1 (very dissatisfied).

  4 weeks

Secondary Outcomes (3)

• To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.

  4 weeks

• To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.

  4 weeks

• To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty by recording the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  4 weeks

Study Arms (1)

Experimental: Restylane-L® Filler injection

EXPERIMENTAL

Drug: Restylane-L® Filler injection

Interventions

Restylane-L® Filler injection DRUG

Restylane-L® Filler injection into the soft tissue of the nose

Experimental: Restylane-L® Filler injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of ages 21 and above.
• Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
• Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.

You may not qualify if:

• Males and females below age of 21.
• Subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
• Subjects who are pregnant or nursing.
• Subjects with a known allergy or sensitivity to any component of the study ingredients.
• Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
• Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
• Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose, implants, and previous surgical rhinoplasty.
• Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.

Sponsors & Collaborators

• DeNova Research: lead
• Galderma R&D: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Study Officials

• Steven Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Assistant Professor

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 19, 2019
• Study Start: January 1, 2019
• Primary Completion: July 20, 2020
• Study Completion: July 21, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

US (1)