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Exosome Therapy
BENEV Exosome Regenerative Complex+ for Hair Loss
N/A
Waitlist Available
Research Sponsored by Ablon Skin Institute Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential must practice effective contraception and have a negative pregnancy test
Be older than 18 years old
Must not have
Subjects using Low Level Laser Therapy (LLLT) or other light therapy for thinning hair
Subjects suffering from specific hair loss disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 120 or end of study visit
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study whether using BENEV Exosome Regenerative Complex+ after a microneedling procedure can help with thinning hair in men and women aged 18-65. Participants
Who is the study for?
This trial is for healthy men and women aged 18-65 who feel their hair is thinning. Participants will undergo a treatment combining BENEV Exosome Regenerative Complex+ with SylFirmX® RF microneedling monthly for four months, followed by a check-up.
What is being tested?
The study tests the effectiveness and safety of BENEV Exosome Regenerative Complex+ when used after SylFirmX® RF microneedling in treating self-perceived thinning hair. It requires four monthly treatments plus follow-up.
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to exosome therapy or microneedling such as redness, swelling, pain at the treatment site, infection risk, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use birth control and my pregnancy test was negative.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am using light therapy for hair loss.
Select...
I have a diagnosed hair loss condition.
Select...
I have an active skin condition on my scalp.
Select...
I can communicate and cooperate with my doctor.
Select...
I have had a hair transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 120 or end of study visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 120 or end of study visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Terminal Hair Counts
Change in Total Hair Counts
Change in Vellus Hair Counts
Secondary study objectives
Change in Hair Shedding Pull Test scores
Change in Hair Treatment Subject Satisfaction Questionnaire scores
Change in Investigator Hair Growth Global Improvement Scale
+7 moreOther study objectives
Change in Clinical laboratory analyses of Complete Metabolic Panel
Changes in Clinical laboratory analyses of Complete Blood Count without Differential and with Platelets
Frequency of both local and systemic Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BENEV Exosome Regenerative Complex+Experimental Treatment1 Intervention
BENEV Exosome Regenerative Complex+® post SylFirmX® RF microneedling procedure applied to the scalp monthly for 4 sessions.
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Who is running the clinical trial?
Benev Company, Inc.Industry Sponsor
2 Previous Clinical Trials
100 Total Patients Enrolled
Ablon Skin Institute Research CenterLead Sponsor
7 Previous Clinical Trials
336 Total Patients Enrolled