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

NCT05970809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    collaborator OTHER

  • Istanbul University - Cerrahpasa

    collaborator OTHER

  • StimuSIL

    lead INDUSTRY

Principal Investigators

  • Server Serdaroğlu, MD · İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-08-30
Completion
2024-10-24

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05970809 on ClinicalTrials.gov