COMPLETED

Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Single-center, Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females With Self-Perceived Thinning Hair

Quick Facts

Study Start:2024-05-06

Study Completion:2025-06-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06376409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Females of all Fitzpatrick skin, and hair types between 18-70 years of age with self-perceived thinning, confirmed by a dermatologist. 2. Willing and able to adhere to the same dietary lifestyles for the duration of the study. 3. Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board 4. General good health, as determined by the Investigator or qualified sub-investigator. 5. Willing and able to attend all study visits and comply with the test product daily instructions. 6. 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). 7. Willing and able to cooperate with the requirements of the study. 8. Able to complete and understand the various questionnaires.	1. Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum. 2. Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator. 3. Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia. 4. Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation. 5. Individuals who have had a history of any acute or chronic medical or hair condition that 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, sun damage, seborrheic dermatitis), infection, 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. 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 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). 11. History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments. 12. 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. 13. 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. 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 interfere with their participation in the study or study results. 17. Known history of or current iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage \>20 cigarettes/day as reported by the subject. 18. 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.

Inclusion Criteria

Exclusion Criteria

1. Females of all Fitzpatrick skin, and hair types between 18-70 years of age with self-perceived thinning, confirmed by a dermatologist.
2. Willing and able to adhere to the same dietary lifestyles for the duration of the study.
3. Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
4. General good health, as determined by the Investigator or qualified sub-investigator.
5. Willing and able to attend all study visits and comply with the test product daily instructions.
6. 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).
7. Willing and able to cooperate with the requirements of the study.
8. Able to complete and understand the various questionnaires.

1. Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
2. Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
3. Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
4. Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation.
5. Individuals who have had a history of any acute or chronic medical or hair condition that 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, sun damage, seborrheic dermatitis), infection, 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.
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 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).
11. History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
12. 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.
13. 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.
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 interfere with their participation in the study or study results.
17. Known history of or current iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage \>20 cigarettes/day as reported by the subject.
18. 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.

Contacts and Locations

Study Locations (Sites)

Integrative Skin Science and Research

Sacramento, California, 95815

United States

Collaborators and Investigators

Sponsor: Nutraceutical Wellness Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-06

Study Completion Date2025-06-16

Study Record Updates

Study Start Date2024-05-06

Study Completion Date2025-06-16

Terms related to this study

Additional Relevant MeSH Terms

Hair Thinning