A Pivotal Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
CynosureLutronic
Summary
The goal of this clinical study is to evaluate the efficacy and safety of the Ultra device for the treatment of hair regrowth by assessing the improvement of hair density and hair shaft diameter.
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 22 - 70 years old * Is willing to undergo study device use. * Fitzpatrick skin type I-VI * Clinical diagnosis of androgenetic alopecia (Norwood-Hamilton II-V or Ludwig I-II) * Willing to avoid significant changes to hair (such as drastic haircuts and dying hair) during their involvement in the study. * Willing to maintain current diet and exercise routine throughout study duration. * Understands and accepts the study condition to not receive any other procedures to the treatment area or to undergo any procedures, take any medications, supplements, or partake in any other…
Interventions
- DeviceLow Level Laser Therapy
Study participants received a total of 6 low level laser therapy treatments on their scalp. The treatments occurred 2 weeks apart (+/- 3 days).
Locations (2)
- Dy DermatologyGlenview, Illinois
- Cynosure LutronicWestford, Massachusetts