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:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05339958
Eligibility Criteria:
Inclusion Criteria:
* Males between 21-55 years of age with self-perceived thinning
* Voluntarily sign and date an informed consent agreement and photo release form approved by the Institutional Review Board
* Clinically confirmed to have hair thinning or loss by the investigator or qualified sub-investigator via physical exam, including only subjects with male pattern hair loss with frontal and/or vertex patterns II, IIA, III, IIIv and IV using the Norwood classification of patterned hair loss in males.
* General good health, as determined by the Investigator or qualified sub-investigator
* Willing and able to attend all study visits and comply with the test product daily instructions.
* Willing to maintain the same hair style and same color for the duration of the study.
* Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth).
* Willing and able to cooperate with the requirements of the study.
* Able to complete and understand the various rating instruments.
Exclusion Criteria:
* Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
* Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
* Subjects with male pattern hair loss with frontal and/or vertex patterns I, IIIA, IVA, V, VA, VI, VII using the Norwood classification of patterned hair loss in males.
* Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
* Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator or qualified sub-investigator, might put the subject at risk or interfere with the study conduct or evaluations.
* History of surgical correction of hair loss on the scalp (i.e. hair transplant).
* Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
* Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, progesterone, and bicalutamide) within 3 months prior to the Baseline Visit.
* History of burning, flaking, itching, and stinging of the scalp.
* History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
* A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the Investigator or qualified sub-investigator may interfere with the study treatment.
* A known history of unstable or chronic depression or bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator or qualified sub-investigator.
* A known allergy to any of the ingredients in the investigational product.
* Utilization of low-level lasers for hair growth in the last three months.
* Any condition that the Investigator thinks may put the subject at risk or interfere with their participation in the study.
* Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage \>20 cigarettes/day.
* Use of any medications or medicated shampoos that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator or qualified sub-investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT05339958
Study Brief:
Protocol Section:
NCT05339958