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NCT05970809: CS-SAGA-001

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

Completed NA Last updated 30 May 2025
What this trial tests

NA trial testing SAGA-001 (A) in Male Pattern Baldness in 82 participants. Completed in 24 October 2024.

Timeline
1 June 2023
Primary endpoint
30 August 2024
24 October 2024

Quick facts

Lead sponsorStimuSIL
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment82
Start date1 June 2023
Primary completion30 August 2024
Estimated completion24 October 2024
Sites2 locations across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

StimuSIL

Who can join

Adults 22 to 55, male only, with Male Pattern Baldness or Androgenetic Alopecia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. From mechanism to applications: Advanced microneedles for clinical medicine.
    Yang Y, Sun H, Sun X, Wang Y, et al · · 2025 · cited 9× · PMID 40463395 · DOI 10.1016/j.bioactmat.2025.04.025

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