Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571799
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex for Self-perceived Thinning Hair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A 4-month Single Arm Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex Post SylfirmX RF Microneedling to Promote Hair Growth in Healthy Men and Women With Self-perceived Thinning Hair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to further substantiate the effectiveness and safety of BENEV Exosome Regenerative Complex post SylFirmX RF microneedling procedure for self-perceived thinning hair in healthy men and women ages 18-65 over the course of four months Participants will be asked to have treatments monthly for 4 sessions attend a follow up appointment 4 weeks after the 4th session have photos taken of their hair and answer questionnaires related to their thinning hair
Detailed Description:
Exosomes represent promising new regenerative medicine treatments for facial rejuvenation and to enhance other cosmetic procedures Exosomes can provide effective treatment for skin rejuvenation scar reduction hyperpigmentation and hair growth This new technology can be used alone but are often combined with other older existing aesthetic treatments Specifically the use of exosomes in hair loss has been anecdotally observed but treatment protocols remain elusive and not universally accepted Since hair loss has a multifactorial etiology and traditional treatments have limitations we explore the use of adipose tissue stem cell derived lyophilized exosomes for novel addition to the armamentarium of options to reverse hair thinning or shedding
Exosome is defined as a 30200 nm endoplasmic reticulum that is secreted for cell-to-cell communication and plays an important role in influencing the microenvironment around cells ExoSCRT is an innovative technology to separate and refine 01 pure exosomes from stem cells and helps the virtualization of natural skin energy by affecting skin cells effectively BENEV Exosome Regenerative Complex is an intensive dual-action complex formulated to absorb quickly into the skin and scalp delivering the concentrated power of stem cell derived lyophilized exosomes potent growth factors peptides coenzymes minerals amino acids and vitamins
The purpose of this clinical research study is to further evaluate the efficacy and safety of BENEV Exosome Regenerative Complex post SylFirmX RF microneedling procedure of the scalp for self-perceived thinning hair in thirty 30 healthy male and female subjects ages 18-65 years of age over the course of four 4 months
Exosome is defined as a 30200 nm endoplasmic reticulum that is secreted for cell-to-cell communication and plays an important role in influencing the microenvironment around cells ExoSCRT is an innovative technology to separate and refine 01 pure exosomes from stem cells and helps the virtualization of natural skin energy by affecting skin cells effectively BENEV Exosome Regenerative Complex is an intensive dual-action complex formulated to absorb quickly into the skin and scalp delivering the concentrated power of stem cell derived lyophilized exosomes potent growth factors peptides coenzymes minerals amino acids and vitamins
The purpose of this clinical research study is to further evaluate the efficacy and safety of BENEV Exosome Regenerative Complex post SylFirmX RF microneedling procedure of the scalp for self-perceived thinning hair in thirty 30 healthy male and female subjects ages 18-65 years of age over the course of four 4 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None