ClinicalTrials.gg
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

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 216 studies in Alopecia with a site in United States — 43 open to participants now, 63 under way, 6 of them phase 3. Alopecia · United States.

Planned enrollment
94th of 203
44 · median 40
Started
2026
with 13 others
No phase
93 of 216
25 open now
Primary completion
2026-12
later than 23 of 62 live
Registered
209th of 216
by date

Among the 216 studies in Alopecia with a site in United States, this one is the 94th largest by planned enrollment of the 203 interventional ones that give a count, is one of 14 that started in 2026, is one of 93 with no phase, reaches primary completion later than 23 of the 62 other live ones, and was the 209th registered.

Alopecia

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

Browse Alopecia studies →

Open to participants now

43 of the 216 studies in Alopecia with a site in United States are open now. Recruiting first, the newest first:

38 more — sign in →

All 43 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 74 Alopecia studies recruiting now, 24 (32%) set no upper age limit and 46 (62%) stop at 75 or younger; 9 take children under 18; 24 take healthy volunteers.

This study: 22 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 216 studies in Alopecia with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Androgenic Alopecia

Browse trials for

Keywords

  • Androgenic Alopecia
04

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

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 diseases, such as AIDS and , or use of immunosuppressive medications
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.

Of 61 industry-sponsored interventional studies with no phase under Alopecia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 10 months is above that.

Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2026
First posted
May 14, 2026
StartActual
Feb 19, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion