NCT07588243 A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
| NCT ID | NCT07588243 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CynosureLutronic |
| Condition | Androgenic Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-02-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07588243 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Androgenic Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07588243 currently recruiting?
Yes, NCT07588243 is actively recruiting participants. Contact the research team at charlotte.antoni@cynosurelutronic.com for enrollment information.
Where is the NCT07588243 trial being conducted?
This trial is being conducted at Glenview, United States, Westford, United States.
Who is sponsoring the NCT07588243 clinical trial?
NCT07588243 is sponsored by CynosureLutronic. The trial plans to enroll 44 participants.