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

Primary Purpose

Deformity of Nasal Cartilage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Restylane-L® Filler injection
Sponsored by
DeNova Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deformity of Nasal Cartilage

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Males and females below age of 21.
  2. Subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
  3. Subjects who are pregnant or nursing.
  4. Subjects with a known allergy or sensitivity to any component of the study ingredients.
  5. 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.
  6. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
  7. Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose, implants, and previous surgical rhinoplasty.
  8. 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.

Sites / Locations

  • DeNova Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Restylane-L® Filler injection

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Secondary assessment of this study is to determine the efficacy of Restylane-L® filler injection into the nose as defined by the reduction of the nasal dorsal convexity to 0mm (+/- 10% of pre injection value) as measured by differences in length of a line (from pre to post injection photos) from the highest tip of the nasal dorsum to a line drawn from the Radix to the supratip region on a lateral view 2D photograph. This will be performed through calculation of changes in nasal dorsal hump convexity for all patients. All measures will be performed in triplicate and the mean of the 3 measures will be used.
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
Subgroup analysis will be performed for the patients who also underwent augmentation of the nasal tip to measure changes in projection (in mm) and rotation (in degrees) achieved from injection of filler. We will be using the Goode method for measuring nasal projection. We will be reporting the following measurements: Nasal projection is the perpendicular distance between the tip-defining point and a line passing through the nasion and alar crease. Nasal length is the distance between the nasion and the tip-defining point. The ideal Goode ratio of 0.55 to 0.60 is the perpendicular distance between the tip-defining point and a line passing through the nasion and alar crease divided by nasal length. Nasal tip rotation or the nasolabial angle (normal 90-120 degrees), is the angle defined by the columellar point-to-subnasale line intersecting with subnasale-to-labrale superius line. The mean of the 3 measurements in (mm for distance) or (degrees for rotation) will be reported.
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
The safety profile of injecting Restylane-L® into the nose will be measured by continually monitoring for AEs during the duration of the study and reporting the total number and description of events.

Full Information

First Posted
November 12, 2019
Last Updated
August 11, 2020
Sponsor
DeNova Research
Collaborators
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04169308
Brief Title
Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty
Official Title
Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life (FACE-Q Scale)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DeNova Research
Collaborators
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deformity of Nasal Cartilage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Restylane-L® Filler injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Restylane-L® Filler injection
Intervention Description
Restylane-L® Filler injection into the soft tissue of the nose
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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.
Description
Secondary assessment of this study is to determine the efficacy of Restylane-L® filler injection into the nose as defined by the reduction of the nasal dorsal convexity to 0mm (+/- 10% of pre injection value) as measured by differences in length of a line (from pre to post injection photos) from the highest tip of the nasal dorsum to a line drawn from the Radix to the supratip region on a lateral view 2D photograph. This will be performed through calculation of changes in nasal dorsal hump convexity for all patients. All measures will be performed in triplicate and the mean of the 3 measures will be used.
Time Frame
4 weeks
Title
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
Description
Subgroup analysis will be performed for the patients who also underwent augmentation of the nasal tip to measure changes in projection (in mm) and rotation (in degrees) achieved from injection of filler. We will be using the Goode method for measuring nasal projection. We will be reporting the following measurements: Nasal projection is the perpendicular distance between the tip-defining point and a line passing through the nasion and alar crease. Nasal length is the distance between the nasion and the tip-defining point. The ideal Goode ratio of 0.55 to 0.60 is the perpendicular distance between the tip-defining point and a line passing through the nasion and alar crease divided by nasal length. Nasal tip rotation or the nasolabial angle (normal 90-120 degrees), is the angle defined by the columellar point-to-subnasale line intersecting with subnasale-to-labrale superius line. The mean of the 3 measurements in (mm for distance) or (degrees for rotation) will be reported.
Time Frame
4 weeks
Title
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
Description
The safety profile of injecting Restylane-L® into the nose will be measured by continually monitoring for AEs during the duration of the study and reporting the total number and description of events.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Dayan, MD
Organizational Affiliation
DeNova Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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