Study of the Ultra Device to Safely Improve Hair Growth and Hair Thickness in Adults with Androgenic Alopecia

What this Trial Is About

This clinical trial focuses on adults aged 22 to 70 with androgenic alopecia, also known as male or female pattern hair loss. It aims to evaluate how well the Ultra device works and how safe it is for promoting hair regrowth by measuring improvements in hair density and hair shaft thickness. The study is sponsored by CynosureLutronic and involves no masking or blinding. Participants will receive six treatments using the Ultra device, which employs low level laser therapy on the scalp. These treatments are spaced about two weeks apart, with a small allowance of plus or minus three days. The study tracks changes from the start of treatment through to a 90-day follow-up after the final treatment. During the study, participants will be monitored for changes in hair density compared to their baseline levels. They will need to avoid significant hair changes like drastic haircuts or coloring and maintain their usual diet and exercise routines. The study requires adherence to visit schedules and restrictions on other hair growth treatments or medications. Safety and treatment effects are observed throughout the study period, which ends in December 2026.

A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth