This clinical trial is testing a new approach to help improve hair thinning using a combination of cosmetic treatments. The purpose of the study is to learn whether applying exosomes to the scalp, along with microneedling and a precision cooling device called TargetCool™. This study aims to determine whether this combination approach offers synergistic benefits for individuals with hair thinning. Exosomes are tiny particles that come from stem cells and contain growth factors and other nutrients. They are being studied for their potential to help regenerate skin and hair. TargetCool™ is an FDA-cleared device that uses precision cooling to reduce inflammation and improve comfort. Microneedling is a common, minimally invasive procedure that uses small needles to stimulate the skin and help absorb topical products more effectively. The study will include healthy men (ages 18 to 70) and women (ages approximately 45 to 70) who are not of childbearing potential. A total of 9 to 15 participants will be randomly placed into one of three groups: Group 1: Exosomes with TargetCool™ Group 2: Microneedling followed by exosomes and TargetCool™ Group 3: Microneedling followed by exosomes only Participants will receive four treatments over 9 weeks. Each visit may include microneedling, TargetCool™ treatment, and exosome application depending on group assignment. A small tattoo will be placed on the scalp to help capture consistent photographs, and a special imaging system (Canfield HairMetrix®) will be used to measure hair changes. Participants will return for follow-up visits at 3 and 6 months after the final treatment. The results will help determine whether this combination of cosmetic treatments is safe and beneficial for people experiencing hair thinning.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
A micropigmentation scalp tattoo will be applied at baseline to mark consistent photographic sites.
Canfield HairMetrix® imaging will be utilized to capture global and trichoscopic hair measurements.
Boosting will be used to apply exosomes
Microneedling will be performed to a depth of 0.5 mm.
Marc Avram MD
New York, New York, United States
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.
Time frame: 32 weeks (8 months)
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.
Time frame: 32 weeks (8 months)
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.
Time frame: 32 weeks (8 months)
Change in average hair width
This is the average hair width calculated in micrometers by the Canfield HairMetrix System.
Time frame: 32 weeks (8 months)
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 delineated visits as indicated in the schedule of events, compared to baseline. The Investigator will complete this assessment at the end of study. 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
Time frame: 32 weeks (8 months)
Change in Subject Hair Self-Assessment Questionnaire scores
Overall hair appearance: 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
Time frame: 32 weeks (8 months)
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
Time frame: 32 weeks (8 months)
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