๐ฌIn plain words
What the trial is, and whether it could suit you
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Healthy males and females, โฅ 18 years of age at time of informed consent, seeking treatment for hair loss
* Subject must voluntarily sign and date an IRB approved informed consent form
* Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
* Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months
* Able to read, understand and voluntarily provide written informed consent
* Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regimen during the study
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
Exclusion Criteria:
* Subject does not have the capacity to consent to the study
* Subject has other types of alopecia of the scalp like alopecia areata
* History of intralesional steroid injections to the scalp in the last 12 months
* Pregnant women
* Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject
* Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months
* Allergy or history of prior reaction to lidocaine
* History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months
* History or current use of the following prescription medications:
i. Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months
* Smoking or vaping in the past 12 months
* History of uncontrolled hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders
* History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism