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

August 29, 2024 updated by: Scale Media Inc
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hair Density and Hair Volume
Time Frame: Baseline, Month 3, and Month 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Skin Health (Fine Lines, Wrinkles, Texture, and Elasticity)
Time Frame: Baseline, Month 3, and Month 6
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scale Media Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citruslabs

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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