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IRCT20260522069491N2 IRCT 2026-07-18 Tehran University of Medical Sciences Comparison of Fotona Laser Combined with Topical Minoxidil versus Topical Minoxidil Alone for the Treatment of Androgenetic Alopecia Evaluating the efficacy of Erbium:YAG laser in Smooth mode with Fotona device combined with topical minoxidil versus topical minoxidil alone on improvement of androgenetic alopecia 2026-07-23 anticipated 50 Recruiting https://irct.ir/trial/91616 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized, double-blind, parallel-group clinical trial. Following the initial assessment and confirmation of eligibility based on the inclusion and exclusion criteria, participants will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence (Random Allocation Software). Participants will be assigned to the intervention and control groups in a 1:1 ratio, with 25 participants in each group. The list assigns each patient a sequential number paired with a code (1 or 2) representing one of the two study groups. The principal investigator is blinded to the meaning of these codes, Blinding description: Based on the patient numbers on the list and the code (1 or 2) recorded in each row, sealed, opaque envelopes are prepared, each labeled on the outside only with the number 1 or 2, while the type of intervention (laser combined with minoxidil, or minoxidil alone) is written inside. These envelopes are given to the treatment-prescribing physician, while the principal investigator remains unaware of the meaning of these codes (i.e., which code represents which intervention). After obtaining the patient's informed consent to participate in the study, the prescribing physician opens the corresponding envelope and administers the assigned intervention (laser or minoxidil) to the patient based on its contents. For dermoscopic imaging, the person performing the dermoscopy is unaware of the patient's assigned group and the type of treatment administered, and only records and reports the images/hair-count results. The dermoscopy results are then forwarded to the statistical analyst, who is likewise unaware of how patients were allocated to each of the two study groups and analyzes the data based solely on the numerical codes (1 or 2). Accordingly, blinding in this study is maintained at three levels: 1. The principal investigator (regarding the meaning of the allocation codes) 2. The person performing dermoscopy/outcome assessor (regarding the patient's treatment group) 3. The statistical analyst (regarding the meaning of the group codes) The only individual aware of the type of intervention is the prescribing physician, who is responsible for administering the intervention based on the envelope's contents; due to the nature of the intervention (the patient's physical presence for laser sessions), blinding of this individual, as well as of the patient, is not feasible. 3 Androgenic alopecia. Intervention 1: Intervention group: Participants in the intervention group (25 patients) will receive Er:YAG laser therapy (Fotona, 2940 nm) using a P30 handpiece with the following parameters: spot size: 7 mm, fluence: 8.5 J/cm², and frequency: 2 Hz. Participants will undergo six treatment sessions at 2-week intervals. At each treatment session, a scalp examination will be performed, and any treatment-related adverse events will be assessed and recorded.Participants in the control group will receive topical minoxidil, applied twice daily for 4 months to the affected areas of the scalp.For hair count assessment, a 2.25 cm² area in the vertex scalp will be selected as the target assessment site. The exact location of this area will be determined and documented using fixed anatomical landmarks, including the glabella, occiput, and auricle. The selected area will then be divided into four quadrants, and standardized dermoscopic images will be obtained from each quadrant.Four months after treatment initiation (Visit 3), dermoscopic imaging of the same target area will be repeated under identical conditions, including the same lighting, imaging angle, and magnification. Hair follicle counts before and after treatment will be recorded and compared. Finally, a blinded physician assessor will evaluate the clinical improvement, and participants will complete a treatment evaluation and satisfaction questionnaire. Intervention 2: Control group: 25 participants will be allocated to the control group and will apply 5% topical minoxidil solution twice daily to the affected areas of the scalp for 4 months.Four months after treatment initiation (Visit 3), dermoscopic imaging of the same predefined target area will be repeated under identical conditions, including the same lighting, imaging angle, and magnification. Hair follicle counts before and after treatment will be determined and recorded.Finally, a blinded physician assessor will evaluate and score the degree of clinical improvement, and participants will complete a treatment evaluation and patient satisfaction questionnaire. No - There is not a plan to make this available Justification or reason for not sharing IPD is No additional information is available
public dr. Zeinab Arianian
Razi Dermatology Hospital, Razi Alley, Vahdat-e Eslami Square, Vahdat-e Eslami Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5288 8282 z_aryanian@yahoo.com Tehran University of Medical Sciences scientific dr. Zeinab Aryanian
Razi Dermatology Hospital, Razi Alley, Vahdat-e Eslami Square, Vahdat-e Eslami Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5288 8282 z_aryanian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of androgenetic alopecia (AGA) by a dermatologist Hamilton–Norwood stage II–V in men or Ludwig stage I–III in women No use of other anti-hair loss treatments within the previous 6 months Age 18–55 years Written informed consent 18 years 55 years Both History of scarring alopecia Pregnancy or breastfeeding Systemic diseases affecting hair loss (hypothyroidism, severe iron deficiency) Use of medications affecting hair growth (e.g., finasteride, dutasteride, or systemic corticosteroids) within the previous 6 months Known hypersensitivity to minoxidil Poor compliance or failure to attend scheduled follow-up visits L64 Androgenic alopecia Treatment - Devices Treatment - Drugs Intervention group: Participants in the intervention group (25 patients) will receive Er:YAG laser therapy (Fotona, 2940 nm) using a P30 handpiece with the following parameters: spot size: 7 mm, fluence: 8.5 J/cm², and frequency: 2 Hz. Participants will undergo six treatment sessions at 2-week intervals. At each treatment session, a scalp examination will be performed, and any treatment-related adverse events will be assessed and recorded.Participants in the control group will receive topical minoxidil, applied twice daily for 4 months to the affected areas of the scalp.For hair count assessment, a 2.25 cm² area in the vertex scalp will be selected as the target assessment site. The exact location of this area will be determined and documented using fixed anatomical landmarks, including the glabella, occiput, and auricle. The selected area will then be divided into four quadrants, and standardized dermoscopic images will be obtained from each quadrant.Four months after treatment initiation (Visit 3), dermoscopic imaging of the same target area will be repeated under identical conditions, including the same lighting, imaging angle, and magnification. Hair follicle counts before and after treatment will be recorded and compared. Finally, a blinded physician assessor will evaluate the clinical improvement, and participants will complete a treatment evaluation and satisfaction questionnaire. Control group: 25 participants will be allocated to the control group and will apply 5% topical minoxidil solution twice daily to the affected areas of the scalp for 4 months.Four months after treatment initiation (Visit 3), dermoscopic imaging of the same predefined target area will be repeated under identical conditions, including the same lighting, imaging angle, and magnification. Hair follicle counts before and after treatment will be determined and recorded.Finally, a blinded physician assessor will evaluate and score the degree of clinical improvement, and participants will complete a treatment evaluation and patient satisfaction questionnaire Hair count. Timepoint: Before treatment and after completion of the treatment course (fourth month). Method of measurement: Dermoscopic image assessment with hair counting performed by the principal investigator. Patient Satisfaction. Timepoint: After completion of treatment. Method of measurement: Patient-reported satisfaction assessed using a three-level scale (low, moderate, high). Tehran University of Medical Sciences Approved 2026-02-08 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Rooms 604–605, 6th Floor, Central Administration Building, Tehran University of Medical Sciences, Corner of Keshavarz Boulevard and Qods Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)