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

NCT05970809 | Completed

• 1 other identifier: CS-SAGA-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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

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

Keywords

lasers; laser therapy; low-level light therapy; Low-Power Laser Therapy; Photobiomodulation Therapy; Low-Level Laser Therapy; Laser Biostimulation; LLLT; microtrauma, physical

Outcome Measures

Primary Outcomes (2)

• Change in terminal hair density

  Changes in terminal hair density at the 24-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.

  24 weeks

• Change in terminal hair density

  Changes in terminal hair density at the 16-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.

  16 weeks

Secondary Outcomes (2)

• Change in hair thickness

  16 weeks

• Change in hair thickness

  24 weeks

Study Arms (2)

Device A

EXPERIMENTAL

Device configuration A has metal and novel microneedles and lasers.

Device: SAGA-001 (A)

Device B

EXPERIMENTAL

Device configuration B has novel microneedles and lasers.

Device: SAGA-001 (B)

Interventions

SAGA-001 (A) DEVICE

Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.

Device A

SAGA-001 (B) DEVICE

Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.

Device B

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is willing to sign an informed consent form
• Subject is within the age group of 22-55 years (including both ages)
• Subject is male
• Subject has AGA with a Stage IIa-V Hamilton-Norwood classification
• Subject's skin is within Fitzpatrick Skin Types I-IV

You may not qualify if:

• Subjects who have used any formulation or application/administration or type of treatment for disorders of the skin or scalp within 180 days prior to screening, including but not limited to the following treatments:
• Anti-inflammatory medications, including topical steroids
• Antifungal
• Skin, nail, hair rejuvenation supplementation, or IV infusions (includes vitamin, minerals, herbals, etc.)
• Hair growth shampoos, conditioners, and topicals
• Topical, dermal or oral minoxidil, finasteride, or dutasteride
• Hair growth stimulation treatments, i.e. PRP, stem cells, exosomes, growth factors, microneedling, mesotherapy
• LED or low level laser therapy treatments, ie. laser helmets, laser caps, and laser combs
• Infrared saunas
• Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia
• Subjects with a history of bleeding disorders
• Subjects on anticoagulant medications (aspirin, warfarin, heparin)
• Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g. humira)
• Subjects with an active infection at the local site
• Subjects with keloidal tendencies

Sponsors & Collaborators

• StimuSIL: lead
• Ankara City Hospital Bilkent: collaborator
• Istanbul University - Cerrahpasa: collaborator

Study Sites (2)

Ankara Bilkent Şehir Hastanesi Dermatoloji Klini

Ankara, Turkey (Türkiye)

Location

İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü Deri ve Zührevi Hastalıklar Ana Bilim Dalı Kocamustafa Paşa

Istanbul, Turkey (Türkiye)

Location

Related Links

• StimuSIL's website

MeSH Terms

Conditions

Alopecia; Microtrauma, Physical

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Server Serdaroğlu, MD

  İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomly allocated at a 1:1 ratio to receive treatment with Device type A or B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: June 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: October 24, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)