Clinical trial NCT06579742: A Clinical Trial to Examine the Efficacy of a Supplement to Support Healthy Hair and Skin
Official title: A Clinical Trial to Examine the Efficacy of a Supplement to Support Healthy Hair and Skin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hair Thinning
Hair Loss
Keywords: Skin Aging
Loss of Skin Elasticity
Skin Health
Hair Health
Lead sponsor: Scale Media Inc
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hair Density and Hair Volume
timeFrame: Baseline, Month 3, and Month 6
Secondary outcomes:
measure: Change in Skin Health (Fine Lines, Wrinkles, Texture, and Elasticity)
timeFrame: Baseline, Month 3, and Month 6
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: