Recruiting NCT07588243
A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Level Laser Therapy.
- Who it may be relevant to
- Registry conditions: Androgenic Alopecia. Basic parameters: 22 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pivotal Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth
Overview
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.
Interventions
- Device Low 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).
Primary outcome measures
- 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.]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Dy Dermatology — Glenview
- Cynosure Lutronic — Westford
Identifiers
NCT: NCT07588243 · 7068-PV01-2026