Phase
Condition
Alopecia
Hair Loss
Treatment
Nutrafol Women's Balance Hair Growth Supplement
Nutrafol Women's Vegan Hair Growth Supplement
Nutrafol Women's Postpartum Hair Growth Supplement
Clinical Study ID
Ages 18-70 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females of all Fitzpatrick skin, and hair types between 18-70 years of age withself-perceived thinning, confirmed by a dermatologist.
Willing and able to adhere to the same dietary lifestyles for the duration of thestudy.
Able to understand and sign an informed consent agreement and photo release formapproved by the Institutional Review Board
General good health, as determined by the Investigator or qualifiedsub-investigator.
Willing and able to attend all study visits and comply with the test product dailyinstructions.
Willing to use a mild non-medicated shampoo and conditioner for the duration of thestudy (medicated shampoo and conditioner refer to any prescription shampoo orconditioner as well as any over-the counter medicated shampoo or conditioner, suchas 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 questionnaires.
Exclusion
Exclusion Criteria:
Individuals who are pregnant, planning a pregnancy, nursing, or within 1-yearpost-partum.
Individuals who have experienced serious complications due to COVID-19 previously orduring the study as determined by the investigator.
Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring formsof alopecia.
Individuals who have had a history of any acute or chronic disease that couldinterfere with or increase the risk on study participation.
Individuals who have had a history of any acute or chronic medical or hair conditionthat could affect study results, such as a history of disordered eating.
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, sundamage, seborrheic dermatitis), infection, cuts, and/ or abrasions on the scalp orcondition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of theInvestigator or qualified sub-investigator, might put the subject at risk orinterfere 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.
Females who have recently (within the last 6 months) started the use of hormones forbirth control or hormone replacement therapy (HRT). Women currently using hormonesfor birth control or HRT must have been on a stable dose (6 months or longer) inorder to be eligible for the study (the initiation of HRT or birth control shouldnot have been associated with the initiation of hair loss/thinning).
History of malignancy (except cutaneous squamous cell carcinoma and basal cellcarcinoma) or currently undergoing chemotherapy or radiation treatments.
A known history of autoimmune thyroid disease, any other thyroiddisorder/abnormality or other autoimmune disorders that in the opinion of theInvestigator or qualified sub-investigator may interfere with the study treatment.
A known history of unstable or chronic depression or bipolar disease or any othercondition that may impact the subject's participation in the opinion of theinvestigator 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 interferewith their participation in the study or study results.
Known history of or current iron deficiency, bleeding disorders or plateletdysfunction syndrome as well as subjects receiving anticoagulant therapy or smokerswith usage >20 cigarettes/day as reported by the subject.
Use of any medications or medicated shampoos that are known to potentially causehair loss or affect hair growth, as determined by the Investigator or qualifiedsub-investigator.
Study Design
Study Description
Connect with a study center
Integrative Skin Science and Research
Sacramento, California 95815
United StatesActive - Recruiting
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