Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)

Skin Aging Clinical Trial

Official title:

The Derm Aid Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249128
• Other study ID #: 2286
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Alopecia
• Cosmetic Acne
• Cutis Laxa
• Hair Loss
• Nails; Soft
• Skin Aging
• Skin Laxity

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