Hair Loss, Skin Laxity, Cosmetic Acne, Nails; Soft, Skin Aging
Conditions
Brief summary
A 90 day eight arm virtual interventional study looking at the impact of various supplement formulations for improves in hair, skin & nail health via self report, and dermatology assessment via remote dermatologist assessment.
Detailed description
This study is being run entirely on the ProofPilot clinical trial platform. Participants enroll online, submit selfies, and are shipped dietary various dietary supplements containing a one or more of Keratin, Astaxanthin, Collagen Peptides and Pro-berry powder in vegan and non-vegan formats. All participants will receive active ingredients but in various fomulations. Half the participants will receive the formations for free. The other half will pay a discounted amount for the supplements.
Interventions
DIETARY_SUPPLEMENTVegetarian Collagen
Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.
DIETARY_SUPPLEMENTKeratin
Keratin (/ˈkɛrətɪn/) is one of a family of fibrous structural proteins known as scleroproteins. α-Keratin is a type of keratin found in vertebrates. It is the key structural material making up hair, nails, feathers, horns, claws, hooves, calluses, and the outer layer of skin among vertebrates.
DIETARY_SUPPLEMENTCeramides
Ceramides are a family of waxy lipid molecules. A ceramide is composed of sphingosine and a fatty acid. Ceramides are found in high concentrations within the cell membrane of eukaryotic cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer.
DIETARY_SUPPLEMENTAstaxanthin
is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
Sponsors
Noho Health
ProofPilot
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study is done completely online. Supplements are fulfilled at a central fulfillment center. The study sponsor, nor any care provider, or investigator know what formulation a participant receives until the end of the study
Intervention model description
Participants are randomized into one of eight arms. The arms include four combinations of dietary supplements for skin, hair & nail health (Keratin, collagen peptides, pro-berry powder, vegan Keratin, and Astaxanthin). Each supplement formation is included in two arms - one arm is paid, the other arm is free.
Eligibility
Sex/Gender
ALL
Age
26 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Continental US * ability and willingness to take selfies
Exclusion criteria
* skin diease * use of retinoids * known allergies * significant facial hair * medically relevant skin disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Self-Report Skin, Hair & Nail Health and Satisfaction | Baseline, 30 Day, 60 Day and 90Day | A custom self-report survey for participants to self-assess their satisfaction on skin, hair and nail status. |
| Blinded Dermatology Assessment of Facial Skin health | Baseline 45 day and 90 day | Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau & customer wrinkle selfie scale |
| Participant Acceptability | weekly | Week by week change and overall analysis of custom survey delivered weekly asking participants to self report acceptability and adherence to treatment regiment over prior week. |
| Paid versus unpaid particpatnt adherence | 30 and 90 Day | Comparison of arms with the same intervention, but one paid, one not, to assess impact on adherence |
Countries
United States
Outcome results
None listed