CompletedNot Applicable

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

Turkey (Türkiye)82 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range22 Years – 55 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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

What they're measuring

Change in terminal hair density

Timeframe: 24 weeks

Change in terminal hair density

Timeframe: 16 weeks

Trial details

NCT IDNCT05970809

SponsorStimuSIL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Male Pattern Baldness trials