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Active, not recruitingNCT07588243Updated Sep 2, 2026

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

An interventional study of Low Level Laser Therapy in Androgenic Alopecia, sponsored by CynosureLutronic. Active, not recruiting at 2 sites in United States. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by CynosureLutronic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
22 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Androgenic Alopecia

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Keywords

  • Androgenic Alopecia
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 129 are open to participants now.

This study's planned enrollment of 44 is close to the median of 45 across 512 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

CynosureLutronic is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
All
Accepts 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 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Ultra Treatment

    Device: Low Level Laser Therapy

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).

06

What researchers measure

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.

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

07

Study locations

2 sites
  • Dy Dermatology
    Glenview, Illinois 60025, United States
  • Cynosure Lutronic
    Westford, Massachusetts 01886, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07588243
Lead sponsor
CynosureLutronic
Responsible party
Sponsor
First posted
May 14, 2026
Start date
Feb 19, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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