Clinical trial NCT04169308: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Deformity of Nasal Cartilage
Lead sponsor: DeNova Research
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2019-11-19
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: 4 weeks
measure: To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: