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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04249128
Other study ID # 2286
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 15, 2020
Est. completion date February 9, 2021

Study information

Verified date February 2021
Source ProofPilot
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 9, 2021
Est. primary completion date January 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 26 Years to 100 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Vegetarian Collagen
Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.
Keratin
Keratin (/'k?r?t?n/) is one of a family of fibrous structural proteins known as scleroproteins. a-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.
Ceramides
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.
Astaxanthin
is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.

Locations

Country Name City State
United States ProofPilot Online App (https://p.proofpilot.com) New York New York

Sponsors (2)

Lead Sponsor Collaborator
ProofPilot Noho Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Self-Report Skin, Hair & Nail Health and Satisfaction A custom self-report survey for participants to self-assess their satisfaction on skin, hair and nail status. Baseline, 30 Day, 60 Day and 90Day
Primary Blinded Dermatology Assessment of Facial Skin health Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau & customer wrinkle selfie scale Baseline 45 day and 90 day
Primary Participant Acceptability 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. weekly
Primary Paid versus unpaid particpatnt adherence Comparison of arms with the same intervention, but one paid, one not, to assess impact on adherence 30 and 90 Day
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