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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT07228156
Eligibility Criteria:
Inclusion Criteria:
* Women and Men Aged 18-65 years with self-perceived hair thinning (confirmed by an investigator).
* Fitzpatrick skin Types I to IV
* Ludwig Scale I or II or Norwood Scale 1 to 4 (mild to moderate thinning hair)
* Agree to maintain their current diet, medication, exercise routines, hair shampooing, and color treatment frequency for the duration of the study.
* Ability and willingness to comply with the study protocol including regular visits and product application.
* Written informed consent obtained, including written consent to allow photographs to be used as part of the study data and documentation.
* For females of childbearing potential, a negative pregnancy test at screening.
* Commitment to using effective contraception throughout the study.
Exclusion Criteria:
* Pregnancy, nursing, planning to become pregnant.
* Initiation of hormone therapy or changes in hormonal therapy within 6 months prior to enrollment and throughout the study.
* Use of other medical hair loss treatments (e.g. Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to the study and throughout the study.
* Microneedling, PRP, or other physical treatment modality on the scalp within 6 months prior to the study and throughout the study.
* Use of GLP-1 inhibitors (e.g. semaglutide) within 6 months prior to the study and throughout the study.
* Known uncontrolled health conditions (poorly controlled diabetes, hypertension).
* History of scalp disorders that could interfere with study results.
* Known sensitivity to any of the ingredients in the study medication.
* In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
* Subject has any conditions, findings in history, physical exam, or laboratory assessments, which in the opinion of the investigator, would exclude the subject from continuing in this study.
* Treatment with an experimental drug, biologic, or device within 12 weeks of the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07228156
Study Brief:
Protocol Section:
NCT07228156