Actively Recruiting
A Pivotal Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
Led by CynosureLutronic · Updated on 2026-05-14
44
Participants Needed
2
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Pivotal 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 through VI
- Clinical diagnosis of androgenetic alopecia (Norwood-Hamilton II-V or Ludwig I-II)
- Willing to avoid significant hair changes such as drastic haircuts or hair dye during the study
- Willing to maintain current diet and exercise routines throughout the study
- Understands and agrees to not receive other hair growth treatments, medications, or procedures during the study
- Able to attend all study visits
- Willing to comply with study requirements and provide written informed consent
You will not qualify if you...
- Female participants who are pregnant, have been pregnant in the last 3 months, are breastfeeding, or planning pregnancy during the study
- Diagnosis of other types of alopecia such as scarring alopecia or alopecia areata
- Use of systemic hair growth medications within 6 months prior to study
- Inconsistent use of vitamins affecting hair growth; must be stable for at least 6 months prior to first treatment
- Previous scalp treatments like laser or topical within 6 months
- Presence of malignant disease, cancer, or uncontrolled medical conditions
- Impaired immune system due to diseases like AIDS or HIV or use of immunosuppressive medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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