Actively Recruiting
A Pivotal Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
Led by CynosureLutronic · Updated on 2026-05-27
44
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on adults aged 22 to 70 with androgenic alopecia, also known as male or female pattern hair loss. It aims to evaluate how well the Ultra device works and how safe it is for promoting hair regrowth by measuring improvements in hair density and hair shaft thickness. The study is sponsored by CynosureLutronic and involves no masking or blinding. Participants will receive six treatments using the Ultra device, which employs low level laser therapy on the scalp. These treatments are spaced about two weeks apart, with a small allowance of plus or minus three days. The study tracks changes from the start of treatment through to a 90-day follow-up after the final treatment. During the study, participants will be monitored for changes in hair density compared to their baseline levels. They will need to avoid significant hair changes like drastic haircuts or coloring and maintain their usual diet and exercise routines. The study requires adherence to visit schedules and restrictions on other hair growth treatments or medications. Safety and treatment effects are observed throughout the study period, which ends in December 2026.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 70 years old
- 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 hair changes during the study
- Willing to maintain current diet and exercise routine throughout the study
- Understands and agrees not to use other hair growth procedures or treatments during the study
- Able to attend all study visits
- Willing to comply with all study requirements and provide written informed consent
You will not qualify if you...
- Female participants who are pregnant, breastfeeding, or planning pregnancy during the study
- Diagnosis of other alopecia types, such as scarring alopecia or alopecia areata
- Use of systemic hair growth medications within 6 months prior to the study
- Inconsistent use of vitamins affecting hair growth; must be stable for at least 6 months
- Previous scalp treatments like laser or topical within 6 months
- Having malignant disease, cancer, or uncontrolled medical conditions
- Impaired immune system due to immunosuppressive diseases or medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 6 low level laser therapy treatments on their scalp to promote hair regrowth.
6 visits (in-person) approximately 2 weeks apart
Duration - 90 days
Participants are monitored 90 days after the last laser treatment to assess hair density changes.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
Dy Dermatology
Glenview, Illinois, United States, 60025
Actively Recruiting
2
Cynosure Lutronic
Westford, Massachusetts, United States, 01886
Actively Recruiting
Research Team
C
Charlotte Antoni Clinical Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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