A Clinical Trial to Examine the Efficacy of a Supplement to Support Healthy Hair and Skin

This is a triple-blinded, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of Scale Media's Live Conscious Beyond Collagen supplement on overall hair and skin health. The study will involve 50 male or female participants aged 40 and over who have self-perceived hair thinning and shedding. The trial will last for 24 weeks and includes the completion of questionnaires and photo submissions at specific time points.

Study Overview

• Status: Active, not recruiting
• Conditions: Hair Loss; Hair Thinning
• Intervention / Treatment: Dietary supplement: Live Conscious Beyond Collagen; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female or male
• Self-perceived hair thinning, specifically on the top and crown of the scalp for at least three months
• Self-perceived increased hair shedding for at least three months
• Concerns regarding skin health and appearance
• Has been using the same hair care routine and products for at least one month prior to the study, i.e., shampoo, conditioner, and products
• Has been using the same skincare routine and products for at least one month prior to the study, i.e., moisturizer, serums, etc.
• Willing to maintain the same hair care routine and products throughout the study
• Willing to maintain the same skincare routine and products throughout the study
• Willing to maintain the same diet and exercise regimen during the study
• Willing to refrain from taking any vitamins, minerals, or herbal supplements that target hair growth or skin health during the study
• Willing to refrain from taking any new vitamins, minerals, or supplements of any kind during the study
• Willing to avoid introducing any new prescription medications or supplements that target hair health and appearance of skin health and appearance during the study
• Be generally healthy and do not live with any uncontrolled chronic disease
• Willing to stop taking any other multivitamin supplements at least one month prior to and for the entire study duration
• Willing to avoid dyeing the hair for the duration of the study
• Living with someone who can take their study photos for the duration of the study

Exclusion Criteria:

• Anyone with a diagnosed hair loss or hair thinning health condition, except for female pattern baldness (e.g., alopecia areata)
• Women who are pregnant, breastfeeding, or trying to conceive
• Anyone currently taking iron supplements
• Anyone unwilling or unable to follow the study protocol
• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
• Anyone who does not consume animal products for personal or religious reasons
• Is undergoing or planning to undergo laboratory testing and/or significant medical procedures during the study duration
• A history of severe allergic reactions, including but not limited to any of the product's ingredients
• Has undergone any chemical treatments to the hair in the last three months, e.g., chemical straightening, hair extensions with chemical bonding, perms, and relaxers
• Has any planned chemical treatments for the hair during the study period, e.g., chemical straightening, hair extensions with chemical bonding, perms, and relaxers
• Has any planned cosmetic treatments to the face, including botox, dermal filler, chemical peels, etc.
• Currently undergoing hair loss treatment, including mechanical scalp stimulation, or has done so in the last three months
• Currently using other hair growth/thickening products
• Currently taking any prescription medication for hair loss, or has done so in the last three months
• Currently taking any prescription medication for skin health, or has done so in the last three months
• Has undergone any surgeries or invasive treatments in the last six months
• Has had any major illness in the last three months
• Currently taking medication that has hair loss as a known or observed side effect
• Currently undergoing or have you recently undergone chemotherapy or radiotherapy
• Anyone who has had a hair transplant within the last year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live Conscious Beyond Collagen Supplement; Participants in this arm will receive the Live Conscious Beyond Collagen supplement. The supplement contains Vitamin C (90 mg), Biotin (2500 mcg), and a Proprietary Collagen Blend (10.1 g) including Types I & III Bovine Collagen, Type II Marine Collagen, Type II Chicken Sternum Collagen, and Types I, V & X Eggshell Membrane Collagen.	Dietary supplement: Live Conscious Beyond Collagen; Participants in the experimental arm will take 1 scoop (10.4 g) of Live Conscious Beyond Collagen supplement mixed with 12 fl oz of water in the evening after their last meal of the day for 24 weeks.
Placebo Comparator: Placebo; Participants in this arm will receive a placebo product. The placebo contains Maltodextrin.	Dietary supplement: Placebo; Participants in the placebo comparator arm will take 1 scoop (10.4 g) of the placebo product (Maltodextrin) mixed with 12 fl oz of water in the evening after their last meal of the day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hair Density and Hair Volume	Hair health will be assessed through expert dermatologist grading and participant questionnaires to measure changes in hair density and hair volume over the course of the study.	Baseline, Month 3, and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Health (Fine Lines, Wrinkles, Texture, and Elasticity)	Skin health will be evaluated using participant self-reported questionnaires and expert dermatologist grading to assess changes in fine lines, wrinkles, skin texture, elasticity, brightness, radiance, firmness, and roughness over the course of the study.	Baseline, Month 3, and Month 6

Collaborators and Investigators

• Sponsor: Scale Media Inc
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Skin Aging; Skin Health; Loss of Skin Elasticity; Hair Health
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis
• Other Study ID Numbers: 20423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No