An interventional study of Scalp tattoo and Canfield HairMetrix® in Hair Diseases, Alopecia and Hair Thinning, sponsored by Recens Medical, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Recens Medical, Inc. · Not applicable, Interventional, and Treatment
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's planned enrollment of 15 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Recens Medical, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Scalp tattoo · Device: Canfield HairMetrix® · Device: TargetCool
Device: Scalp tattoo · Device: Canfield HairMetrix® · Device: TargetCool · Device: Microneedle-facilitated lidocaine application
Device: Scalp tattoo · Device: Canfield HairMetrix® · Device: Microneedle-facilitated lidocaine application
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.
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)
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.
Time frame: 32 weeks (8 months)
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in this study will be shared.
Supporting information: Study protocol, Icf
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hair Diseases
Recens Medical, Inc.