Impact of a Topical Cosmetic Product on Women's Hair

NCT06060834 | Completed

• 1 other identifier: PRO-FY2024-1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed pilot study will investigate the impact of a daily topical nutritional product applied to women's hair, specific to perceived hair quality and overall well-being. Hair loss will be measured with a scanning application ("MyHairCounts") , as well as with the 60-second hair comb test. This will be an open-label study with a sample of 15 women and will be used to generate pilot data for future, larger-scale placebo-controlled studies.

Conditions

Hair Thinning; Hair Loss

Outcome Measures

Primary Outcomes (13)

• Hair Density

  Hair density as determined by "MyHairCounts" application

  baseline

• Hair Density

  Hair density as determined by "MyHairCounts" application

  After 2 weeks of treatment

• Hair Density

  Hair density as determined by "MyHairCounts" application

  after 1 month of treatment

• 60 second hair count

  Number of hairs lost when hair is combed for 60 seconds

  baseline

• 60 second hair count

  Number of hairs lost when hair is combed for 60 seconds

  After 2 weeks of treatment

• 60 second hair count

  Number of hairs lost when hair is combed for 60 seconds

  after 1 month of treatment

• Self-assessment of well-being

  An adaptive visual analog scale will be used to self-assess feelings of confidence, self-consciousness, motivation, and attractiveness/beautifulness on a continuous scale from 0 (not at all) to 10 (extreme).

  baseline

• Self-assessment of well-being

  An adaptive visual analog scale will be used to self-assess feelings of confidence, self-consciousness, motivation, and attractiveness/beautifulness on a continuous scale from 0 (not at all) to 10 (extreme).

  After 2 weeks of treatment

• Self-assessment of well-being

  An adaptive visual analog scale will be used to self-assess feelings of confidence, self-consciousness, motivation, and attractiveness/beautifulness on a continuous scale from 0 (not at all) to 10 (extreme).

  After 1 month treatment

• Product assessment

  An adaptive visual analog scale will be used to self-assess feelings on the smell, ease of use, and self-reported feeling of hair quality using a continuous scale from 1 (not at all) to 10 (Very much).

  after 1 month of treatment

• Self-assessment of hair

  An adaptive visual analog scale will be used to self-assess feelings on subject's hair (thickness, fullness, shininess, texture, strength, appearance, satisfaction using a continuous scale from 1 (extremely poor) to 10 (Excellent) as well as compliments, split ends on a scale from 1 (Never) to 10 (Very often), ease of styling 1 (very difficult) to 10 (very easy), and speed of hair growth 1 (slow) to 10 (very fast).

  baseline

• Self-assessment of hair

  An adaptive visual analog scale will be used to self-assess feelings on subject's hair (thickness, fullness, shininess, texture, strength, appearance, satisfaction using a continuous scale from 1 (extremely poor) to 10 (Excellent) as well as compliments, split ends on a scale from 1 (Never) to 10 (Very often), ease of styling 1 (very difficult) to 10 (very easy), and speed of hair growth 1 (slow) to 10 (very fast).

  After 2 weeks of treatment

• Self-assessment of hair

  An adaptive visual analog scale will be used to self-assess feelings on subject's hair (thickness, fullness, shininess, texture, strength, appearance, satisfaction using a continuous scale from 1 (extremely poor) to 10 (Excellent) as well as compliments, split ends on a scale from 1 (Never) to 10 (Very often), ease of styling 1 (very difficult) to 10 (very easy), and speed of hair growth 1 (slow) to 10 (very fast).

  After 1 month of treatment

Secondary Outcomes (9)

• Systolic Blood pressure

  baseline

• Diastolic Blood pressure

  baseline

• Diastolic Blood pressure

  After 2 weeks of treatment

• Systolic Blood pressure

  After 2 weeks of treatment

• Diastolic Blood pressure

  After 1 month of treatment

Study Arms (1)

Application of product

EXPERIMENTAL

Apply intervention to wet hair on scalp and massage in for 30 seconds after shampooing (if applicable), daily.

Dietary Supplement: Topical Botanical Agent

Interventions

Topical Botanical Agent DIETARY_SUPPLEMENT

Cayenne Pepper, Coconut Water, Kelp, Lemon Juice, Oxynex LM, Potassium Sorbate, Red Palm Oil, Rose Water, Saw Palmetto, vitamin C

Application of product

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age 35-70 years
• Subjects should have limp or visibly thin hair, and claim to have experienced mild to moderate hair thinning
• Willing to follow the protocol requirements as evidenced by written informed consent.
• Agree not to use any medication, including vitamins and minerals, or any cosmetic products during or before the course of this study, which are designed to impact hair health.
• Willing to download the MyHairCounts \| Hair Loss Prevention \| Hair Density Tracking app for use in study assessments.
• Willing to come to the lab for all follow-up visits.
• Have a regular/stable menstrual cycle if not post-menopausal (e.g., 27-32 days).
• Not lactating, pregnant or planning to become pregnant during the study
• Not have any clinically significant medical history (including alopecia), medical finding or an on-going medical or psychiatric condition which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
• Not have baldness or significant loss of hair, to the extent that the topical product would not remain on the scalp and would run off following application, or if there is such minimal or short hair that an improvement in appearance would not be able to be evaluated.
• Use of any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
• No history of allergic/sensitivity reactions to product components.
• Must be able to hang loose naturally (unsecured and without hair extensions)

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of College of Health Sciences

Model Details: pre-post experiment

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: August 3, 2023
• Primary Completion: December 14, 2023
• Study Completion: January 25, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)