Loading clinical trials...

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

RECRUITINGNA

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

NCT06885112•Lumenis Be Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed Description

The FoLix laser system contains Erbium:Glass Fiber Laser Technology with a wavelength of 1565 nm. It is the first FDA cleared fractional laser device for treatment of hair loss that has demonstrated safety and efficacy.

Eligibility

Age

21 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and females between 21 - 55 years of age, inclusive.
•Have Fitzpatrick Skin Type V to VI.
•Have mild to moderate hair loss (Ludwig scale I-II for women, Norwood-Hamilton scale I-III for males)
•Have self-reported thinning or hair loss for more than 6 months prior to screening but less than 5 years.
•Clinically confirmed to have hair loss or thinning by the investigator via physical exam
•Didn't receive hair-loss treatments or participated in a clinical study using 1565 NAFL device
•In good general health, as determined by the Investigator
•Willing and able to attend all study visits
•Willing to maintain the same hair style as at the Screening Visit for the duration of the study. If coloring hair, willing to color it with the same frequency of usage as in the past, making sure not to color within 1-week before and 1-week after an in-office appointment
•Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth)
+5 more criteria

Exclusion Criteria

•Clinical diagnosis of alopecia areata or scarring forms of alopecia
•Patient is of skin type I-IV
•Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
•Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. Subjects of childbearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as postmenopausal (e.g.: absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy
•Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
•Participated in a previous 1565 NAFL study or treatment
•History of surgical correction of hair loss on the scalp/ Hair transplants.
•Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 90 days prior to the Baseline Visit.
•Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 60 days prior to the Baseline Visit.
•No history of burning, flaking, itching, and stinging of the scalp.
+9 more criteria

Locations (1)

UnionDerm

New York, New York, United States

Key Dates

Start Date

February 21, 2025

Primary Completion Date

February 21, 2027

Completion Date

February 21, 2027

Last Updated

January 2, 2026

Enrollment

ESTIMATED participants

Conditions

Hair Loss

Interventions

FoLix treatment for improving the scalp hair appearance

DEVICE

Contacts

Keren Hayut

CONTACT

+972506905252 keren.hayut@lumenis.com

Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo

NCT07111299

Early Female Pattern Hair Loss (FPHL)

View study

SUSPENDEDNA

Cleansing Device for the Treatment of Scalp and Hair Conditions

NCT05319444

DandruffSeborrheic Dermatitis+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo

Cleansing Device for the Treatment of Scalp and Hair Conditions

Scalp Care Efficacy Evaluation for Premium Scalp Revitalizing Essence

Successful Treatment of Female Pattern Hair Loss With Injection of Nanofat With and Without Platelet-Rich Plasma

Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss

To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia