Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT06946550
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
* Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
* Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
* Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil 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 throughout the follow-up period.
Exclusion Criteria:
* Subject does not have capacity to consent to the study
* No ethnic or racial group restrictions
* Subject does not have scarring alopecia
* 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 hospitalization or 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 in the prior 12 months.
* Recent COVID-19 infection
* History or current use of the following prescription medications:
* Immunosuppressive medications/biologics, 6 months prior to and during the study
* Accutane or other systemic retinoids within the past twelve months
* Smoking or vaping in the past 12 months.
* History of uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled hepatitis, or uncontrolled bleeding disorders.
* History of major depressive disorders or uncontrolled endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06946550
Study Brief:
Protocol Section:
NCT06946550