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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02297360
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 associated with poor diet, stress, hormone influences or abnormal menstrual cycle 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 and 2
8. Females with Fitzpatrick I-IV photo skin types
9. Willingness to have digital photography of the target area and scalp for hair counts at Visits 1 and 2
10. 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 and 2
11. Willingness to have their hair washed (shampooed) with Viviscal Gentle Shampoo over a sink containing cheesecloth for hair shedding counts at Visits 1 and 2
12. Willingness to maintain a consistent hair cut and hair color throughout the 3 month study period and to come to visits with clean (shampoo must be done 24 hours or more prior to the visit) and dry hair
13. 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 Visit 2)
Exclusion Criteria:
1. Females with a known history of intolerance or allergy to fish, seafood/shellfish or acerola
2. Females with any known allergy or sensitivity to any shampoo/conditioner
3. Females who are nursing, pregnant, planning to become pregnant during the study
4. Females with known stressful incident within the last six months (ie. death in family, miscarriage)
5. Females who are participating on any clinical research study at ASIRC or at another research center or doctor's office
6. 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
7. Females currently using the HairMax light treatment or other light therapy to treat thinning hair
8. Females who have regularly used Rogaine (Minoxidil) within the last 3 months
9. 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)
10. 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
11. 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 Investigators
12. Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease
13. 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.)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02297360
Study Brief:
Protocol Section:
NCT02297360