Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser

Part of paid clinical trials in New York, New York.

Sponsor
Lumenis Be Ltd.
Study ID
NCT06885112
Status
Recruiting
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Conditions

  • Hair Loss

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • FoLix treatment for improving the scalp hair appearance — DEVICE
    The study patients will receive 4 FoLix treatment in 4 weeks intervals. the scalp hair improvement will be evaluated by 3 blinded assessors who shall review before and after images, as well as hair count data

Study Details

The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6

Key Dates

Start date
Feb 21, 2025
Status verified
Mar 2025
Primary completion
Feb 21, 2027
Completion
Feb 21, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: healthy subjects with moderate hair loss stage and skin color type 5 or 6
    The FoLix is FDA cleared for hair loss treatments in patients with skin type 1 to 4. It is no being studied for patients with skin type 5 and 6 to allow expending the product labeling

Primary Outcome Measure

improvement in scalp hair appearance by comparing before and after images [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UnionDermNew YorkNew York10003
Anne Chapas, MD, Medical Doctor
[email protected]
212-366-5400
Anne Chapas, MD, Medical Doctor (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
UnionDerm· New York, NY

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