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

To evaluate and compare the efficacy of Erbium:YAG laser (Fotona, Smooth mode) plus topical 5% minoxidil versus topical 5% minoxidil alone on androgenetic alopecia (hair follicle count, severity, satisfaction) in patients at Razi Hospital.

Randomized, evaluator-blinded, parallel-group clinical trial with two arms, using simple random allocation at a 1:1 ratio.

Conducted at Razi Hospital dermatology clinic, Tehran. Eligible patients give written consent and are randomized (Random Allocation Software) 1:1. Baseline visit records demographics, disease duration, severity, and dermoscopic imaging. Intervention group undergoes 6 laser sessions (2-week intervals) with adverse-event monitoring; control group applies minoxidil for 4 months. At 4 months, dermoscopic imaging is repeated under identical conditions; a blinded evaluator assesses response, and patients complete a satisfaction questionnaire.

Inclusion: age 18–55; confirmed diagnosis of androgenetic alopecia; Hamilton-Norwood grade 2–5 (men) or Ludwig grade I–III (women); no other anti-hair-loss treatment in past 6 months; written informed consent. Exclusion: scarring alopecia; pregnancy/breastfeeding; systemic diseases affecting hair loss; use of finasteride, dutasteride, or systemic corticosteroids in past 6 months; minoxidil hypersensitivity; poor compliance/follow-up.

Intervention group: Erbium:YAG laser, Smooth mode (2940 nm, P30 handpiece, fluence 8.5 J/cm², frequency 2 Hz, spot size 7 mm), 6 sessions at 2-week intervals, combined with topical 5% minoxidil twice daily. Control group: Topical 5% minoxidil twice daily for 4 months, without laser.

Hair follicle count in a standardized 2.5 cm² vertex area via dermoscopy (baseline vs. 4 months); patient satisfaction.

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.

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.

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