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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT03206567
Eligibility Criteria:
Inclusion Criteria:
1. Females, ages 21-65 years of age.
2. Clinically-determined general good health as determined by responses to the initial study assessment.
3. Females with self-perceived thinning hair as determined on initial study assessment by the Investigator (This will not include patients with medically diagnosed telogen effluvium).
4. Females willing to maintain their normal hair shampooing frequency.
5. Females willing to add the provided oral supplement to their current daily routine.
6. Females willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
7. Females willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. The physical exam will occur at Visits 1, 2 and 3.
8. Women of child bearing potential should be willing to have a urine pregnancy test and will comply with a medically sound contraception method (including barrier control, abstinence, etc.). Women who are on birth control should have been on it for at least 6 months and willing to continue the same method of birth control. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
9. Females with Fitzpatrick I-IV photo skin types.
10. Willingness to have 2D digital photography of the entire head/hair region for overall evaluation of general hair growth and fullness at Visits 1, 2 and 3.
11. Willingness to have digital macrophotography of the target area and scalp for hair counts at Visits 1, 2 and 3.
12. Willingness to have a bundle of hair measured by the Hair Check device for Hair Mass Index (HMI) at Visits 1, 2 and 3.
13. Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements at Visits 1, 2 and 3.
14. Willingness to maintain a consistent hair cut and hair color throughout the 6 month study period and to come to visits with clean, dry hair.
15. Willingness of subjects who have color treated hair to have the color treatment performed at the same time interval prior to each visit (ie. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2 and 3).
Exclusion Criteria:
1. Females with any known allergy or sensitivity to any shampoo/conditioner.
2. Females who are nursing, pregnant, planning to become pregnant during the study.
3. Females with known stressful incident within the last six months (ie. death in family, miscarriage)
4. Females who are participating on any clinical research study at ASIRC or at another research center or doctor's office.
5. Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
6. Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
7. Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
8. Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., hormone-based birth control for less than 6 months, cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).
9. Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator.
10. No history of burning, flaking, itching, and stinging of the scalp.
11. History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
12. A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that are not controlled in the opinion of the investigator may interfere with the study treatment.
13. A known history of depression or bi-polar disease or any other condition that may impact the subject's participation.
14. Is involved in any injury litigation claims.
15. Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects taking anticoagulant therapy, antiplatelet medications, more than one (1) 325 mg ASA on a daily basis or smokers with usage \>20 cigarettes/day.
16. Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigator.
17. Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
18. Females having a known active dermatologic condition which, in the opinion of the examining Investigators, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.).
19. Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03206567
Study Brief:
Protocol Section:
NCT03206567