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IRCT20260624069936N1 IRCT 2026-09-09 Iran University of Medical Sciences Study of standard treatment plus intradermal injection of microbotox versus standard treatment lonely in the treatment of Androgenetic Alopecia ( AGA ) Study of efficacy, satisfaction and safety of standard treatment plus intradermal injection of microbotox versus standard treatment lonely in the treatment of Androgenetic Alopecia ( AGA ): A single blind controlled randomized clinical trial 2025-08-23 anticipated 20 Recruiting https://irct.ir/trial/92988 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients will be evaluated at 1 and 3 months after completion of the study by a blinded dermatologist. The degree of treatment response in both groups will be assessed by a blinded dermatologist. N/A Androgenetic Alopecia. Intervention 1: Intervention group: In this group, in addition to standard treatment with topical minoxidil 5% applied to the scalp once daily for 6 months , an interventional procedure involving intradermal injection of microbotox into the scalp once monthly for a total of three sessions will also be performed.The microbotox solution will be prepared as follows: one 500-unit vial of zibonta (botulinum toxin type A) will be reconstituted with 3 mL of normal saline. Then, 0.5 mL of the resulting solution will be drawn into a 1-mL syringe, followed by the addition of 0.5 mL of normal saline to the syringe. Thus, each 1-mL syringe will contain 100 units of botulinum toxin.Thirty minutes prior to the injection, a topical anesthetic cream will be applied to the intended treatment area. The microbotox will then be injected intradermally into the scalp at injection points spaced 1 cm apart, extending from 1 cm posterior to the hairline to the vertex. Intervention 2: Control group: For this group, standard treatment for androgenetic alopecia will consist of topical minoxidil 5% solution applied to the scalp once daily for 6 months. Yes - There is a plan to make this available What will be shared: All data may be shared after de-identification of the participants When: شروع دوره دسترسی 6 ماه پس از چاپ نتایج To whom: The study data and documentation will be made available to individuals at academic and scientific institutions, as well as to employees of pharmaceutical companies. Conditions: Access to the study data and documentation will be permitted after removal of identifying information and de-identification of the participants, solely for scientific and educational research purposes. The data must be used within the scope of scientific and research objectives, and any commercial use, re-identification of participants, or disclosure of identifiable information will be prohibited. Requests for access must include the research purpose, type of data required, proposed analytical methods, and the intended use and data storage procedures. Requests will be reviewed and approved by the principal investigator and/or the relevant university authorities in accordance with applicable regulations. Statistical and research analyses related to scientific objectives will be permitted, provided that confidentiality is maintained and the participants cannot be identified. Where to obtain: Applicants seeking access to the study data or documentation may submit a written request via email to the principal investigator. The request should include the applicant’s name and contact information, institutional affiliation, purpose of the request, type of data or documentation required, and intended use of the requested materials. Requests will be reviewed and responded to by the principal investigator and, if necessary, by the relevant university authorities, in accordance with applicable regulations. Contact information: Principal Investigator: Dr. Mohaddeseh Shokrallahi Email: M100124sh@gmail.com How to obtain: Applicants should submit their requests via email to the principal investigator. Each request will be reviewed with regard to the research purpose, type of data requested, and intended use of the data. Upon approval of the request and confirmation that the eligibility requirements have been met, the requested data and documentation will be provided in a de-identified and non-identifiable format. The review and preparation of the requested data will generally be completed within a maximum of 30 business days from receipt of a complete request. If review by the relevant university authorities is required, the response time may depend on the duration of the review process by the respective authorities Comments:
public Mohadeseh Shokrollahi
Hazrat Fatemeh Hospital, Asadabadi Street ,23rd Street, Yousef Abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8810 7658 m100124sh@gmail.com Iran University of Medical Sciences scientific Doctor Tahereh Rahimi
Hazrat Fatemeh Hospital, 23rd Street, Asadabadi Street, Yousef Abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 m100124sh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Male patients with androgenetic alopeciaPatient compliance with the prescribed therapeutic interventions and attendance at all treatment sessions and follow-up visits No uptake treatment for at least three months prior to enrollment no limit no limit Male Presence of liver disease History of allergy to any of the treatment modalities Patients receiving medications that may interact with the treatment modalities XII Diseases of the skin and subcutaneous tissue Treatment - Other Treatment - Drugs Intervention group: In this group, in addition to standard treatment with topical minoxidil 5% applied to the scalp once daily for 6 months , an interventional procedure involving intradermal injection of microbotox into the scalp once monthly for a total of three sessions will also be performed.The microbotox solution will be prepared as follows: one 500-unit vial of zibonta (botulinum toxin type A) will be reconstituted with 3 mL of normal saline. Then, 0.5 mL of the resulting solution will be drawn into a 1-mL syringe, followed by the addition of 0.5 mL of normal saline to the syringe. Thus, each 1-mL syringe will contain 100 units of botulinum toxin.Thirty minutes prior to the injection, a topical anesthetic cream will be applied to the intended treatment area. The microbotox will then be injected intradermally into the scalp at injection points spaced 1 cm apart, extending from 1 cm posterior to the hairline to the vertex. Control group: For this group, standard treatment for androgenetic alopecia will consist of topical minoxidil 5% solution applied to the scalp once daily for 6 months. Hair dermoscopic findings include:- Hair density- Vellus hairs- Yellow dots- Perifollicular signs- Hair shaft density- Hair shaft diameter variability. Timepoint: At baseline and at 1 and 3 months after completion of treatment. Method of measurement: Dermatoscop. Improvement in the overall appearance of the hair, as assessed by Visioface imaging obtained from multiple views. Timepoint: At baseline and at 1 and 3 months after completion of treatment. Method of measurement: Assessment of VisioFace images for macroscopic improvement in hair appearance from multiple views, including the frontal view (hairline), three-quarter views, vertex, and occipital view. Patient satisfaction with the improvement achieved following the therapeutic interventions. Timepoint: At baseline and at 1 and 3 months after completion of treatment. Method of measurement: Questionnaire. Iran University of Medical Sciences Approved 2025-06-24 Ethics committee of Iran University of Medical Sciences Skin Clinic, Fatemeh Hospital, 23rd Street, Asadabadi Street, Yousef Abad, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)