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

NCT07588243 | Recruiting FDA Device

• 1 other identifier: 7068-PV01-2026
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Androgenic Alopecia

Keywords

Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

• Difference in the Change in Hair Density from Baseline vs 90-day Follow-up

  To evaluate the difference in the change in hair density at baseline vs 90 day follow up in a pre-determined measurement point in the treatment area as measured with a professional dermascope.

  From baseline (treatment 1) to the 90 day follow up after treatment 6.

Study Arms (1)

Ultra Treatment

EXPERIMENTAL

Device: Low Level Laser Therapy

Interventions

Low Level Laser Therapy DEVICE

Study participants received a total of 6 low level laser therapy treatments on their scalp. The treatments occurred 2 weeks apart (+/- 3 days).

Ultra Treatment

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CynosureLutronic: lead

Study Sites (2)

Dy Dermatology

Glenview, Illinois, 60025, United States

RECRUITING

Cynosure Lutronic

Westford, Massachusetts, 01886, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Charlotte Antoni Clinical Research Coordinator

CONTACT

9786276614; charlotte.antoni@cynosurelutronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)