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Official title Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser
ClinicalTrials.gov ID: NCT06885112
What this study is testing
- What it's testing
- The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
- people who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. people of...
- Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp...
- Participated in a previous 1565 NAFL study or treatment
See the full eligibility 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...
- 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...
- Have a negative urine pregnancy test at screening and be using, and continue to use for the duration of the study, an effective contraception method (i.e., abstinence, barrier control, intrauterine device [IUD], or...
- Be willing and able to cooperate with the requirements of the study including images taken using a smart camera (multi-spectral) of several skin conditions
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board
- Be able to complete and understand the various rating instruments in English
- Sponsor approved global image assessment of degree of thinning / hair loss
- 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
- people who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. people of childbearing potential who are not using an approved method of birth control...
- 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...
- 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.
- A chronic condition of high severity dandruff.
- History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
- A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the investigator may interfere with the study treatment.
- A known history of untreated or uncontrolled depression or bipolar disease or any other condition that may impact the subject's participation.
- Recent utilization of low level lasers for treating hair loss (past 6 months).
- Has any condition that the treating investigator or PI thinks may put the Subject at risk or interfere with their participation in the study.
- Is involved in any injury litigation claims.
- Known history or recent bloodwork indicating iron deficiency (ferritin level is less than 30 ng/mL), bleeding disorders or platelet dysfunction syndrome as well as people receiving anticoagulant therapy or smokers with...
- Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.