Androgenic AlopeciaNCT07588243
A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
A study testing Low Level Laser Therapy in people with Androgenic Alopecia, run by CynosureLutronic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dy Dermatology
Glenview, Illinois, 60025
Cynosure Lutronic
Westford, Massachusetts, 01886
About this study
Official title: 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.
- Conditions
- Androgenic Alopecia
- Being tested
- Low Level Laser Therapy
- Keywords
- Androgenic Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Study participants received a total of 6 low level laser therapy treatments on their scalp. The treatments occurred 2 weeks apart (+/- 3 days).
| Study group | Role | What they receive |
|---|---|---|
| Ultra Treatment | Experimental | Not described Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (treatment 1) to the 90 day follow up after treatment 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start19 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588243
- Sponsor's protocol ID
- 7068-PV01-2026
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
- ClinicalTrials.gov ID
- NCT07588243
- Acronym / sponsor ID
- 7068-PV01-2026
- Conditions
- Androgenic Alopecia
- Keywords
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultra Treatment | Experimental | Device: Low Level Laser Therapy |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyStudy participants received a total of 6 low level laser therapy treatments on their scalp. The treatments occurred 2 weeks apart (+/- 3 days). | Device | Ultra Treatment |
Primary outcome
Difference in the Change in Hair Density from Baseline vs 90-day Follow-up
Time frame: From baseline (treatment 1) to the 90 day follow up after treatment 6.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Androgenic Alopecia, run by CynosureLutronic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Change in Hair Density from Baseline vs 90-day Follow-up (time frame: From baseline (treatment 1) to the 90 day follow up after treatment 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.