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

ConditionHair Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorLumenis Be Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FoLix treatment for improving the scalp hair appearance

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators