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

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

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.

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 treatments indicated for hair growth throughout the length of the study.
• Understands and accepts the study condition of and agrees that he or she is able to be present for all study visits.
• Willing to comply with all requirements of the study and is able to provide written informed consent.

Exclusion Criteria:

• Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding, or planning a pregnancy during the study period.
• Has a diagnosis of other forms of alopecia (e.g., scarring alopecia, alopecia areata)
• Has recent use (within 6 months) of a systemic hair growth medications (e.g., oral finasteride).
• Inconsistent use of vitamins that can affect hair growth - must have stabilized use for at least 6 months prior to first treatment.
• Had previous treatment (such as laser or topical) to scalp within 6 months.
• Has a malignant disease, cancer, or uncontrolled medical condition.
• Has an impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications