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IRCT20160427027636N8 IRCT 2025-08-02 Mazandaran University of Medical Sciences Efficacy and safety of exosome therapy versus mesotherapy on male and female pattern hair Efficacy and safety of exosome therapy versus mesotherapy on male and female pattern hair loss: Randomized controlled trial 2025-08-23 anticipated 60 Recruiting https://irct.ir/trial/84973 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A patient randomization list will be generated using the balanced block randomization method with the help of an online randomization website. Then, a list will be generated using the original generator section of *randomization.com* with blocks of 6. These will be placed sequentially into sealed envelopes. After preparing the sealed envelopes, the list will be destroyed. Patients will be randomly assigned in a 1:1:1 ratio into one of three groups. Group A will include patients who will receive *exosome therapy alone*, once a month for three months. Group B will include patients who will receive a *combination of exosome therapy and mesotherapy, once a month for three months. Group C will include patients who will receive *mesotherapy alone*, once a month for three months. All patients will be evaluated one month after the final intervention session to assess their response to treatment. 1-2 Androgenetic alopecia with male and female pattern hair loss. Intervention 1: Intervention group: Group A will include patients who receive exosome therapy alone once a month for three months. Intervention 2: Intervention group: Group B will include patients who receive a combination of exosome and mesotherapy once a month for three months. Intervention 3: Intervention group: Group C will include patients who receive mesotherapy alone once a month for three months. Yes - There is a plan to make this available What will be shared: Title: Dataset and Documentation for the Clinical Trial on Exosome Therapy vs. Mesotherapy for Hair Loss Details: The dataset includes de-identified individual participant data related to the primary outcome (blinded Investigator Global Aesthetic Improvement Scale, blinded-IGAIS) and secondary outcomes (Patient Global Aesthetic Improvement Scales, PGAIS; patient satisfaction; reported side-effects). Additional documentation includes the study protocol, statistical analysis plan, and case report forms. Only de-identified data will be shared to protect participant privacy. Aggregate data, such as summary statistics and results published in the final report, may also be shared. When: Data and documentation will be available starting 6 months after the publication of the primary study results and will remain accessible for a period of 5 years. To whom: Access to the data and documentation will be restricted to academic researchers affiliated with recognized universities or research institutions. Requests from industry researchers may be considered on a case-by-case basis, provided they demonstrate a clear scientific purpose aligned with the study’s objectives. Conditions: The data and documentation may be used for non-commercial research purposes, such as secondary analyses, meta-analyses, or validation studies, provided they align with the original study’s objectives. Users must agree to: Not attempt to re-identify participants. Use the data solely for the approved research purpose. Cite the original study and acknowledge Mazandaran University of Medical Sciences in any publications or presentations. Submit a formal request detailing the intended use, including the proposed analysis plan. Sign a data use agreement ensuring compliance with ethical standards and data protection regulations. Requests will be reviewed by the study’s principal investigator and the Mazandaran University of Medical Sciences Research Ethics Committee. Where to obtain: Requests for data or documentation should be directed to the principal investigator, Dr. Ghasem Rahmatpour Rokni, via email at dr.rokni@yahoo.com Vice-Chancellor for Research and Technology Mazandaran University of Medical Sciences Moallem Square, Sari, Mazandaran, Iran Phone: 09125443956 Requests can also be submitted through the university’s research portal: [insert website, if applicable]. The principal investigator or a designated member of the research team will respond to inquiries. How to obtain: Applicants must submit a formal request via email or the university’s research portal, including a detailed proposal outlining the intended use of the data/documents, the research objectives, and the proposed analysis plan. The request will be reviewed by the principal investigator and the Mazandaran University of Medical Sciences Research Ethics Committee within 4 weeks. If approved, the applicant will be required to sign a data use agreement. De-identified data and/or documentation will be provided in a secure format (e.g., encrypted files) within 2 weeks of agreement signing. The entire process, from request submission to data delivery, is expected to take approximately 6–8 weeks, barring unforeseen delays. Comments:
public Ghasem Rahmatpour Rokni, MD
Bualisina Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 3847748158 +98 11 3334 2334 dr.rokni@yahoo.com Mazandaran University of Medical Sciences scientific Ghasem Rahmatpour Rokni
Bu-Ali Sina hospital
Sari Iran (Islamic Republic of) 3847748158 +98 11 3322 1755 dr.rokni@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) "Man and woman aged 18 to 60 years, healthy and not pregnant" "Male pattern hair loss (MPHL) grade III to IV based on the Norwood-Hamilton scale" "Female pattern hair loss (FPHL) with early localized or diffuse hair loss corresponding to grade I-3 to III based on the Ludwig scale" Patients who are in a stable state of improvement or worsening after one year of treatment with medications such as minoxidil, finasteride, dutasteride, and spironolactone, or who continue to experience hair loss after six months of medication use. Patients who have undergone follicular unit extraction and transplantation and experience hair thinning and shedding in both the transplanted and non-transplanted areas of the scalp one year after surgery. Patients undergoing treatment and monitoring for estrogen, progesterone, testosterone, and other pituitary or thyroid replacement therapies, yet continue to experience hair thinning and shedding. Willingness and ability to provide written informed consent for photography and authorization prior to undergoing any study-related procedures. 18 years 60 years Both L64 Androgenetic alopecia (male and female pattern hair loss) Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Group A will include patients who receive exosome therapy alone once a month for three months Intervention group: Group B will include patients who receive a combination of exosome and mesotherapy once a month for three months. Intervention group: Group C will include patients who receive mesotherapy alone once a month for three months Blinded investigator global aesthetic improvement scale. Timepoint: Assessments will be conducted at baseline, monthly after each injection for a total of three months, and once more in the fourth month, which corresponds to one month after the final treatment session. Method of measurement: Ludwig and Hamilton scale questionnaire. Patient satisfaction. Timepoint: "At the end of four months from the start of the intervention". Method of measurement: Questionnaire. Patient global aesthetic improvement scale. Timepoint: "At the end of four months from the start of the intervention". Method of measurement: Questionnaire. Reported side effects. Timepoint: "At the end of four months from the start of the intervention". Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2025-07-12 Ethics Committee, Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Moalem square Sari Mazandaran Iran (Islamic Republic of)