Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex+ for Self-perceived Thinning Hair
- Conditions
- Thinning Hair
- Interventions
- Other: BENEV Exosome Regenerative Complex+
- Registration Number
- NCT06571799
- Lead Sponsor
- Ablon Skin Institute Research Center
- 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 30\~200 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 0.1% 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BENEV Exosome Regenerative Complex+ BENEV Exosome Regenerative Complex+ BENEV Exosome Regenerative Complex+® post SylFirmX® RF microneedling procedure applied to the scalp monthly for 4 sessions.
- Primary Outcome Measures
Name Time Method Change in Terminal Hair Counts Baseline to Day 120 or End of Study Visit 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.
Change in Vellus Hair Counts Baseline to Day 120 or End of Study Visit 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.
Change in Total Hair Counts Baseline to Day 120 or End of Study Visit Total hairs equals the sum of Terminal and Vellus hairs in the target area. This is calculated by the Canfield HairMetrix System.
- Secondary Outcome Measures
Name Time Method Change in average hair width Baseline to Day 120 or End of Study Visit This is the average hair width calculated in micrometers by the Canfield HairMetrix System.
Change in inter-follicular hair mean distance Baseline to Day 120 or End of Study Visit This is the distance between hair follicles measured in millimeters by theCanfield HairMetrix System.
Change in average hairs per follicular unit Baseline to Day 120 or End of Study Visit This is the average number of hairs measured in each follicular unit.This is calculated by the Canfield HairMetrix System.
Change in Subject Hair Self-Assessment Questionnaire scores Baseline to Day 120 or End of Study Visit 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 HealthChange in follicular hair units per cm2 Baseline to Day 120 or End of Study Visit This is the number of follicles per cm2 measured by the Canfield HairMetrix System.
Change in Investigator Hair Quality Global Improvement Scale Baseline to Day 120 or End of Study Visit 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 improvedChange in Hair Shedding Pull Test scores Baseline to Day 120 or End of Study Visit 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.
Change in Terminal to Vellus Hair Count Ratio Baseline to Day 120 or End of Study Visit 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.
Change in Investigator Hair Growth Global Improvement Scale Baseline to Day 120 or End of Study Visit 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 improvedChange in Hair Treatment Subject Satisfaction Questionnaire scores Baseline to Day 120 or End of Study Visit 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
Trial Locations
- Locations (1)
Ablon Skin Institute & Research Center
🇺🇸Manhattan Beach, California, United States