Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex+ for Self-perceived Thinning Hair
NCT Number: NCT06571799
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thinning Hair
Interventions: OTHER: BENEV Exosome Regenerative Complex+
Sponsor: Ablon Skin Institute Research Center
Collaborators: Benev Company, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09
Locations: Ablon Skin Institute & Research Center, Manhattan Beach, California, 90266, United States

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.

Primary Outcome Measures: Change in Terminal Hair Counts, Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. This is calculated by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in Vellus Hair Counts, Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. This is calculated by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in Total Hair Counts, Total hairs equals the sum of Terminal and Vellus hairs in the target area. This is calculated by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit
Secondary Outcome Measures: Change in Terminal to Vellus Hair Count Ratio, Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. This ratio is calculated by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in average hairs per follicular unit, This is the average number of hairs measured in each follicular unit.This is calculated by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in average hair width, This is the average hair width calculated in micrometers by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in follicular hair units per cm2, This is the number of follicles per cm2 measured by the Canfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in inter-follicular hair mean distance, This is the distance between hair follicles measured in millimeters by theCanfield HairMetrix System., Baseline to Day 120 or End of Study Visit|Change in Investigator Hair Growth Global Improvement Scale, The treating Investigator will complete this assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement at delinated visits as indicated in the schedule of events, compared to baseline. The Investigator will complete this assessment during the study at Visits 2, 3, 4 and 5. The Investigator must complete this assessment using global photographs obtained compared to baseline. In addition, the Investigator may use their clinical judgment from the in-person visit.

* 3 Greatly worsened
* 2 Moderately worsened
* 1 Slightly worsened 0 No change

  * 1 Slightly improved
  * 2 Moderately improved
  * 3 Greatly improved, Baseline to Day 120 or End of Study Visit|Change in Investigator Hair Quality Global Improvement Scale, The treating Investigator will complete this assessment by circling the number on the scale that corresponds to the description that best fits the current hair quality at delinated visits as indicated in the schedule of events, as compared to the subject's hair quality at baseline. Assessment grading is to be based upon the Investigator's appraisal of hair brittleness, dryness, texture, shine, scalp coverage and overall appearance. The Investigator will complete this assessment during the study at Visits 2, 3, 4 and 5. The Investigator must complete this assessment using global photographs obtained compared to baseline. In addition, the Investigator may use their clinical judgment from the in-person visit.

* 3 Greatly worsened
* 2 Moderately worsened
* 1 Slightly worsened 0 No change

  * 1 Slightly improved
  * 2 Moderately improved
  * 3 Greatly improved, Baseline to Day 120 or End of Study Visit|Change in Hair Shedding Pull Test scores, The hair pull test will be performed by the Investigator to evaluate hair shedding. In the hair pull test, gentle traction will be applied on a group of hairs (approximately 60 hairs) from proximal to distal end, in the vertex area, both parietal areas and occipital area of the scalp. The grasp is made with the help of the thumb, index finger and middle finger, ensuring consistent pressure with each pull. If more than 10% (\~6 or more) hairs come out with every pull, the test is considered positive. Subjects will be instructed not to shampoo or wash their hair 24 hours prior to the test for accurate results., Baseline to Day 120 or End of Study Visit|Change in Subject Hair Self-Assessment Questionnaire scores, This scale is used to rate the qualities listed below:

1. Greatly Decreased/Worsened
2. Moderately Decreased/Worsened
3. Slightly Decreased/Worsened
4. No Change
5. Slightly Increased/Improved
6. Moderately Increased/ Improved
7. Greatly Increased/ Improved

Overall hair growth Overall hair volume Scalp coverage Hair thickness Hair Fullness Hair quality Hair shine Hair strength Hair softness Amount of noticeable new hair Hair growth rate Hair growth on top of your head (scalp coverge) Hair growth of the hairline (at the front of your head or hairline coverage) Hair length (ability to grow longer than usual) Ease of styling Overall hair appearance Nail Strength Nail Growth Rate Growth of Eyebrow Hair Growth of Eyelashes Skin Smoothness Overall Skin Health, Baseline to Day 120 or End of Study Visit|Change in Hair Treatment Subject Satisfaction Questionnaire scores, 1. How satisfied are you with this treatment for your thinning hair? 5 = Very Satisfied 4 = Satisfied 3 = Neutral 2 = Dissatisfied 1 = Very Dissatisfied
2. How satisfied are you with the overall health of your hair after this treatment? 5 = Very Satisfied 4 = Satisfied 3 = Neutral 2 = Dissatisfied 1 = Very Dissatisfied
3. Overall, how satisfied are you with the ease of this treatment? 5 = Very Satisfied 4 = Satisfied 3 = Neutral 2 = Dissatisfied 1 = Very Dissatisfied
4. Overall, now that you have tried this treatment and completed the study, how likely are you to continue the treatment in the future? 5 = Very Likely 4 = Somewhat Likely 3 = Neutral 2 = Somewhat Unlikely 1 = Very Unlikely
5. Overall, how likely are you to recommend this treatment to a family member or friend? 5 = Very Likely 4 = Somewhat Likely 3 = Neutral 2 = Somewhat Unlikely 1 = Very Unlikely, Baseline to Day 120 or End of Study Visit
Other Outcome Measures: Frequency of both local and systemic Adverse Events, An adverse event is any adverse change from the subject's baseline condition, i.e. any subjective signs and symptoms, or change in a concomitant disease present at the screening visit. This includes inter-current signs, symptoms, illness and significant deviations from baseline which may occur during the course of the clinical study, whether considered related to treatment or not., Baseline to Day 120 or End of Study Visit|Changes in Clinical laboratory analyses of Complete Blood Count without Differential and with Platelets, Number of participants with abnormal clinical laboratory analyses of Complete Blood Count with Differential and with Platelets Panel (this is a single blood panel). The analyses will be conducted on blood samples collected from subjects at Baseline and Day 120 visits. All results will be reported, including results that are abnormal. The Complete Blood Count with Differential and with Platelets Panel (single blood panel) contains the following tests: WBC, RBC,Hemoglobin, Hematocrit, MCV, MCH, MCHC, RDW, Platelets, Baseline to Day 120 or End of Study Visit|Change in Clinical laboratory analyses of Complete Metabolic Panel, Number of participants with abnormal clinical laboratory analyses of Complete Metabolic Panel (this is a single blood panel). The analyses will be conducted on blood samples collected from subjects at Baseline and Day 120 visits. All results will be reported, including results that are abnormal. The Complete Metabolic Panel includes the following tests:alkaline phosphatase(ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, blood urea nitrogen (BUN), creatinine, sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium, Baseline to Day 120 or End of Study Visit