Aging Clinical Trial
Official title:
An Evaluator -Blinded, Split-Neck, Randomized Clinical Study Investigating the Efficacy and Safety of Restylane Refyne for Correction of Static Horizontal Neck Rhytides Utilizing Either a Cannula or Needle
Verified date | June 2021 |
Source | Siperstein Dermatology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects with grades ranging from 1---3 on the Transverse Neck Line Scale, will be randomized to receive up to 1cc of Restylane Refyne on one side of their neck utilizing a cannula and up to 1cc of Restylane Refyne on the other side utilizing a 30--gauge needle. On Day 30, this treatment with the same left---right assignment can be repeated if optimal correction on either side has not been achieved according to the treating investigator. Subjects will return 24--48 hours after their first treatment, to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding adverse events. Subjects will also return 30 days after their final treatment to fill out final questionnaires, take pictures, and to be assessed by blinded evaluators regarding improvement of static rhytides.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | September 30, 2021 |
Est. primary completion date | January 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Provision of signed and dated informed consent form - Stated willingness to comply with all study procedures and availability for the duration of the study - In good general health as evidenced by medical history - For females of reproductive potential: use of highly effective contraception - Score of 1--3 on a validated transverse neck line scale3 Exclusion Criteria: - Subjects with allergies to hyaluronic acid filler. - Subjects with auto--immune conditions - Subjects with diabetes - Subjects taking anti--coagulants, diuretics, anti-histamines, or anti--inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the 60 day study. - Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery. - Subjects who had neuromodulators in the past 6 months or fillers in the previous 2 years in the neck area - Subjects who at any time had surgery or permanent fillers in the neck area - Subjects with scars, tattoos, or many skin growths in the neck area - Subjects unwilling or unable to sit still while an injector places Restylane Refyne in the neck - Subjects unwilling or unable to keep their head still during the photos - Subjects who are pregnant or nursing - Female subjects unable to take or use some form of birth control - Subjects with any neck bruising or swelling - Subjects with current skin infections, tumors, herpes outbreak or dermatitis on the neck |
Country | Name | City | State |
---|---|---|---|
United States | Siperstein Dermatology | Boynton Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Siperstein Dermatology | Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in transverse neck rhytides | Difference in the mean absolute change from baseline on a 5--point validated transverse neck line scale. The lowest score 0 signifies no line and a better outcome while the highest score 4 signifies a worse outcome. | Baseline to 30 days after the last treament | |
Secondary | Adverse Events | The number of reported adverse events and the difference between the two sides in the mean number of adverse events | Day 1 to Day 30 | |
Secondary | Global Aesthetic Improvement Scale | Global aesthetic improvement scale as rated by subjects and evaluators. This is a 4 point scale with a 5 point scale with a -1 as the lowest score signifying a lower outcome and 3 as the highest score signifying the best outcome. | 30 Days after the last treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Completed |
NCT05293730 -
Trial of the Impact of the Electronic Frailty Integrated With Social Needs
|
N/A | |
Recruiting |
NCT03932162 -
Gene Expression Changes In Young and Geriatric Skin
|
Early Phase 1 | |
Completed |
NCT04064528 -
Effects of Age on Amino Acid Delivery to Tendon
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT05566938 -
Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly
|
N/A | |
Recruiting |
NCT05543980 -
Leg Heat Therapy in Elderly Individuals
|
Phase 2 | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Not yet recruiting |
NCT06071130 -
Emotion, Aging, and Decision Making
|
N/A | |
Enrolling by invitation |
NCT04641663 -
Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)
|
N/A | |
Completed |
NCT04088006 -
The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
|
N/A | |
Completed |
NCT03695081 -
Patient Pathway Pharmacist - Optimal Drug-related Care
|
N/A | |
Recruiting |
NCT05424263 -
Acetate and Age-associated Arterial Dysfunction
|
Phase 2 | |
Completed |
NCT05601713 -
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling
|
N/A | |
Completed |
NCT04551339 -
Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
|
N/A | |
Recruiting |
NCT04997577 -
Speech Perception and High Cognitive Demand
|
N/A | |
Completed |
NCT05922475 -
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
|
N/A | |
Completed |
NCT04015479 -
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
|
N/A |