Alopecia Areata Trial, Recruiting NCT06786078 Sponsor: Luminate Medical, Inc. Condition: Alopecia Areata
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Alopecia Areata Trial, Recruiting

NCT06786078
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 18 years or older and have been diagnosed with stage 1, 2, or 3 breast cancer
  • Your doctor has decided that chemotherapy before or after surgery is the right treatment for you, and you have not yet started any cancer treatment
  • You are scheduled to receive at least 4 cycles of chemotherapy through a drip (IV), using one of the specific drug combinations listed in the trial (confirm with trial site for the full list)
  • Your head size falls within the range that fits the device used in this study (confirm with trial site)
  • Your chemotherapy is planned to be completed within 12 months
  • You are willing and able to give your signed agreement to take part
  • You are willing to wear the study device on your head before, during, and for 2 to 4 hours after each chemotherapy session
  • You are willing to fill in questionnaires and have photos taken of your head at each visit

Who may not be able to join:

  • You already have some hair loss before starting the trial
  • You have a history of an autoimmune condition that causes hair loss, such as alopecia areata or lupus
  • You have previously had radiation treatment to your whole brain
  • You had chemotherapy within the last 2 years that caused hair loss
  • You are currently taking or planning to take hormone or anti-estrogen therapy that is known to cause hair loss during the study period
  • Your chemotherapy plan involves receiving both a taxane and an anthracycline drug on the same day
  • You are pregnant (a pregnancy test will be done before you start, as is standard for chemotherapy patients)
  • You have a known or suspected allergy to any part of the device that touches your skin
  • You have a history of jaw joint disorder (Temporomandibular Joint Disorder)
  • You have open wounds or sores on your scalp or face where the device would be placed that are not expected to heal before chemotherapy starts
  • You have a serious infection or other serious illness that could prevent you from completing your chemotherapy
  • You have another life-threatening cancer at the same time
  • You have cancer that has spread to your scalp, or this is suspected
  • You are already using a cold cap or any other device aimed at reducing hair loss
  • In your doctor's opinion, joining this trial would not be appropriate or safe for you
  • You are not able to keep to the schedule or follow the study requirements, physically or mentally
  • You are currently in, or have been in within the last 30 days, another clinical trial that could cause hair loss
  • You have taken part in this same trial before

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 28 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: +1 (713) 855-3775

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
Luminate Medical, Inc.
Registry
ClinicalTrials.gov
Start date
20 December 2024
Est. completion
1 July 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Success in hair preservation using the Lily device after 4 cycles of chemotherapy, where hair preservation is defined as CTCAE v5.0 grade ≤ 1 alopecia determined by an independent healthcare professional.; Primary Safety Endpoint - Subject incidence of Grade 1 or above ADE, graded with Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

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: 28 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