NCT05970809

Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss

A Randomised, Evaluator-Blinded, Two-Arm Study To Evaluate The Safety And Efficacy of a Novel Microneedle and Laser-Based Medical Device For The Treatment of Androgenetic Alopecia in Adult Males

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: StimuSIL · Industry
• Sex: Male
• Age: 22 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at helping people with male pattern hair loss. Two different device configurations are being explored as part of this study. Device A has novel microneedles, lasers, and additional metal microneedles, while Device B only has novel microneedles and lasers. Participants will receive 12 treatments with either Device A or Device B over the course of 24 weeks. Treatments will be performed on-site every two weeks.

Detailed description

Participants will have the medical tests or procedures described below: * Subjects will be asked about their previous medical history and current medications. * Brief physical examinations will be performed, including a visual inspection of the scalp. * Questions about medical history (including previous and current medication use) will be asked. * Two types of photos will be taken: 1) "global photos", which are general photos of the subject's scalp, and 2) "macro photos", which are close-up photos of a part of the subject's scalp. * Questions about treatment-related issues or unpleasantness will be asked. * Subjects will be asked to rate the improvement they see in their photos. * Subjects will be asked to rate their satisfaction with the treatment. Participants will also be asked to record changes in medications, changes in medical treatments, and major life changes (such as major dietary changes, exercise changes, changes in life stressors, etc.) in a diary for the duration of treatment. They should also make note of any suspected side effects or issues they believe are related to the treatment.

Conditions

• Male Pattern Baldness
• Androgenetic Alopecia
• Hair Loss/Baldness
• Hair Loss
• Pattern Baldness

Interventions

Type	Name	Description
DEVICE	SAGA-001 (A)	Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.
DEVICE	SAGA-001 (B)	Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-08-30
• Completion: 2024-10-24
• First posted: 2023-08-01
• Last updated: 2025-05-30

Locations

2 sites across 1 country: Turkey (Türkiye)