Alopecia Areata Trial, Recruiting NCT06885112 Sponsor: Lumenis Be Ltd. Condition: Alopecia Areata
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Alopecia Areata Trial, Recruiting

NCT06885112
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 21 and 55 years old (inclusive)
  • You have a darker skin tone, classified as Fitzpatrick Skin Type V or VI (confirm with trial site)
  • You have mild to moderate hair loss or thinning (as assessed by the trial team using standard hair loss scales)
  • You have noticed thinning or hair loss for more than 6 months but less than 5 years before your screening appointment
  • A doctor at the trial site has confirmed your hair loss or thinning through a physical exam
  • You have not previously used hair loss treatments or taken part in a study involving a specific laser device called the 1565 NAFL
  • You are considered to be in good general health, as determined by the trial doctor
  • You are able and willing to attend all required study visits
  • You are willing to keep the same hairstyle throughout the study, and if you color your hair, to do so at the same frequency as before — but not within one week before or after any clinic appointment
  • You are willing to use only a mild, non-medicated shampoo and conditioner for the entire study (this means avoiding prescription shampoos and over-the-counter medicated products, such as anti-dandruff or hair-growth shampoos)
  • If you could become pregnant, you have a negative pregnancy test at screening and are using an effective form of birth control for at least one full menstrual cycle before the study (if using a coil/IUD or hormonal contraceptives, for at least 2 years before screening, and the start of that contraception should not have coincided with the start of your hair loss)
  • You are comfortable having photos taken of your scalp using a special multi-spectral camera
  • You are willing to sign a consent form approved by an ethics review board
  • You can read and understand study questionnaires written in English
  • The trial sponsor has reviewed and approved an overall assessment of your level of hair thinning or loss

Who may not be able to join:

  • You have been diagnosed with a specific type of hair loss called alopecia areata, or a scarring form of hair loss
  • Your skin tone falls within Fitzpatrick Skin Types I to IV (lighter skin tones)
  • Your scalp hair loss in the treatment area is caused by a disease, injury, or medical treatment
  • You are pregnant, planning to become pregnant, or currently breastfeeding
  • You have an active skin condition (such as psoriasis, eczema, skin cancer, or severe sun damage), or cuts, abrasions, sunburn, or tattoos on your scalp that the doctor feels could interfere with the study
  • You have previously taken part in a study or received treatment using the 1565 NAFL laser device
  • You have had surgical hair loss correction or a hair transplant
  • You have used any products or devices intended to promote hair growth (such as finasteride or minoxidil) within the 90 days before your first study visit
  • You have used certain hormone-blocking medications (such as spironolactone or similar therapies) within 60 days before your first study visit
  • You have no history of burning, flaking, itching, or stinging of the scalp (confirm with trial site)
  • You have a chronic severe dandruff condition
  • You have a history of cancer (other than certain treated skin cancers), or are currently undergoing chemotherapy or radiation
  • You have a known history of autoimmune thyroid disease, any other thyroid condition, or other autoimmune disorders that the trial doctor feels could affect the study
  • You have a history of untreated or uncontrolled depression, bipolar disorder, or any other condition that could affect your ability to participate
  • You have used low-level laser therapy for hair loss within the past 6 months
  • You have any condition that the trial doctor believes could put you at risk or affect your participation
  • You are currently involved in any injury-related legal claims
  • You have a known history of iron deficiency (low ferritin levels), bleeding disorders, or platelet problems, or you are taking blood-thinning medication, or you smoke more than 20 cigarettes per day
  • You are taking any medications known to potentially cause hair loss or affect hair growth, as determined by the trial doctor

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +972506905252

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Lumenis Be Ltd.
Registry
ClinicalTrials.gov
Start date
21 February 2025
Est. completion
21 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

improvement in scalp hair appearance by comparing before and after images

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov