Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females

Last updated: September 23, 2024
Sponsor: Nutraceutical Wellness Inc.
Overall Status: Active - Recruiting

Phase

N/A

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

NCT06376409
NW-HGN-02
  • Ages 18-70
  • Female
  • Accepts Healthy Volunteers

Study Summary

A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Females of all Fitzpatrick skin, and hair types between 18-70 years of age withself-perceived thinning, confirmed by a dermatologist.

  2. Willing and able to adhere to the same dietary lifestyles for the duration of thestudy.

  3. Able to understand and sign an informed consent agreement and photo release formapproved by the Institutional Review Board

  4. General good health, as determined by the Investigator or qualifiedsub-investigator.

  5. Willing and able to attend all study visits and comply with the test product dailyinstructions.

  6. 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).

  7. Willing and able to cooperate with the requirements of the study.

  8. Able to complete and understand the various questionnaires.

Exclusion

Exclusion Criteria:

  1. Individuals who are pregnant, planning a pregnancy, nursing, or within 1-yearpost-partum.

  2. Individuals who have experienced serious complications due to COVID-19 previously orduring the study as determined by the investigator.

  3. Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring formsof alopecia.

  4. Individuals who have had a history of any acute or chronic disease that couldinterfere with or increase the risk on study participation.

  5. 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.

  6. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.

  7. 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.

  8. History of surgical correction of hair loss on the scalp (i.e., hair transplant).

  9. 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.

  10. 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).

  11. History of malignancy (except cutaneous squamous cell carcinoma and basal cellcarcinoma) or currently undergoing chemotherapy or radiation treatments.

  12. 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.

  13. 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.

  14. A known allergy to any of the ingredients in the investigational product.

  15. Utilization of low-level lasers for hair growth in the last three months.

  16. Any condition that the Investigator thinks may put the subject at risk or interferewith their participation in the study or study results.

  17. 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.

  18. 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

Total Participants: 180
Treatment Group(s): 4
Primary Treatment: Nutrafol Women's Balance Hair Growth Supplement
Phase:
Study Start date:
May 06, 2024
Estimated Completion Date:
June 01, 2025

Study Description

A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 45 subjects will be enrolled into each of the 4 supplement groups. Subjects will undergo a baseline, baseline

  • 48 hours, 90 day, 90 day + 48 hours, 180 day and 180 day + 48 hours visit and will have compliance phone calls at Days 45 and 135. All subject data will be compared to baseline in paired comparison for each subject using a historical control.

Connect with a study center

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Active - Recruiting

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