Platelet Rich Fibrin for Tear Trough Rejuvenation

NCT03313934 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 20171835
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.

Conditions

Tear Trough Hollowing, Under Eye Bags

Keywords

Hyaluronic Acid Filler; Platelet Rich Fibrin (PRF); Tear Trough Filler

Outcome Measures

Primary Outcomes (2)

• Overall Tear Trough Rejuvenation

  Restoration of volume loss and improved skin quality of the tear troughs

  1 month

• Improvement of Facial Rhytids

  Reduction in wrinkles and appearance of "crepey" skin.

  12 months

Study Arms (2)

Hyaluronic Acid Filler with Saline

PLACEBO COMPARATOR

For each subject, one tear trough will be injected with hyaluronic acid filler mixed with saline. This arm will act as a control to evaluate the efficacy of PRF with hyaluronic acid.

Combination Product: Hyaluronic Acid Filler and Saline

Hyaluronic Acid Filler with Platelet Rich Fibrin (PRF)

EXPERIMENTAL

For each subject, one tear trough will be injected with hyaluronic acid filler mixed with Platelet Rich Fibrin (PRF). This study seeks to determine the efficacy of PRF in volumization of the tear trough and improvement of skin quality. This is the experimental condition.

Combination Product: Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF)

Interventions

Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) COMBINATION_PRODUCT

The use of Restylane-L to volumize the tear trough has been well documented. Combining Restylane-L with Platelet Rich Fibrin (PRF) will be studied to evaluate if PRF enhances the volumization and skin quality of the treated areas.

Also known as: Restylane-L

Hyaluronic Acid Filler with Platelet Rich Fibrin (PRF)

Hyaluronic Acid Filler and Saline COMBINATION_PRODUCT

This intervention will use saline as a control to compare with PRF when mixed with hyaluronic acid fillers. Saline will dilute the HA filler in the same way PRF will, however saline as no growth factors or properties that will enhance treatment.

Also known as: Restylane-L

Hyaluronic Acid Filler with Saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males/females aged 20-80 who are experiencing moderate volume loss of the tear troughs and/or under eye bags. Eligible subjects will be in generally good health and able to provide a blood sample for treatment.

You may not qualify if:

• Those who fall outside of the age range 20-80 years of age, with chronic health problems including but not limited to thyroid disorders, cancer, blood disease, etc. Those who do not demonstrate volume loss of the tear troughs to the degree that warrants intervention. Conversely, those who are better suited for surgical intervention as opposed to non-surgical injections will not be eligible.

Sponsors & Collaborators

• Rejuva Medical Aesthetics: lead

Study Sites (1)

Rejuva Medical Aesthetics

Los Angeles, California, 90025, United States

Location

MeSH Terms

Interventions

Restylane-L; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kian Karimi, MD,FACS

  Rejuva Medical Aesthetics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex N Reivitis, BA

CONTACT

4246442400; alex@rejuvamedical.org

Sherry Leigh, BA

CONTACT

8187269917; sherry@rejuvamedical.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subject will not be aware of which tear trough has the PRF condition. Additionally, the blind observer, who is going to evaluate improvement based on before/after photos, will also be blind to to which tear trough as treated with the PRF condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Model Details: 10 subjects will receive treatment with hyaluronic acid fillers for tear trough rejuvenation. Each subject with have one tear trough treated with HA filler mixed with Platelet Rich Fibrin, and the other tear trough injected with HA filler mixed with saline. The subject with be blind as to which tear trough contains the PRF. This will be randomly assigned for each subject and documented by the CRC.

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)