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

The Derm Aid Study

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Skin Laxity; Hair Loss; Cosmetic Acne; Nails; Soft
• Intervention / Treatment: Dietary supplement: Vegetarian Collagen; Dietary supplement: Keratin; Dietary supplement: Ceramides; Dietary supplement: Astaxanthin

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • ProofPilot Online App (https://p.proofpilot.com)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veg Collagen & Keratin Free (Hair Skin Nails); Participants will receive a free 3 month supply of Collagen & Keratin for Hair, Skin & Nail Health	Dietary supplement: Vegetarian Collagen; Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.; Dietary supplement: Keratin; 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.
Experimental: Veg Collagen Extended with Powder Free (Hair Skin Nails); Participants will receive a free 3- month supply of Collagen & Keratin for Hair, Skin & Nail Health extended with a pro-berry powder	Dietary supplement: Vegetarian Collagen; Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.; Dietary supplement: Keratin; 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.
Experimental: Veg Collagen & Keratin $$$ (Hair Skin Nails); Participants will receive a paid 3-month supply of Collagen & Keratin for Hair, Skin & Nail Health	Dietary supplement: Vegetarian Collagen; Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.; Dietary supplement: Keratin; Keratin (/ˈkɛrətɪn/) is one of a family of fibrous structural proteins known as scleroproteins. α-Keratin is a type of keratin found in vertebrates. It is the key structural material making up hair, nails, feathers, horns, claws, hooves, calluses, and the outer layer of skin among vertebrates.
Experimental: Veg Collagen Extended with Powder $$$ (Hair Skin Nails); Participants will receive a paid 3-month supply of Collagen & Keratin extended with pro-berry powder for Hair, Skin & Nail Health	Dietary supplement: Vegetarian Collagen; Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.; Dietary supplement: Keratin; 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.
Experimental: Ceramides and Astaxanthin Free (Skin); Participants will receive a free 3-month supply of ceramides and Astaxanthin for Hair, Skin & Nail Health	Dietary supplement: 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.; Dietary supplement: Astaxanthin; is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
Experimental: Ceramides and Astaxanthin Extended with Powder Free (Skin); Participants will receive a free 3-month supply of Ceramides and Astaxanthin for Hair, Skin & Nail Health	Dietary supplement: 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.; Dietary supplement: Astaxanthin; is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
Experimental: Ceramides and Astaxanthin $$$ (Skin); Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin & Nail Health	Dietary supplement: Ceramides; Ceramides are a family of waxy lipid molecules. A ceramide is composed of sphingosine and a fatty acid. Ceramides are found in high concentrations within the cell membrane of eukaryotic cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer.; Dietary supplement: Astaxanthin; is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
Experimental: Ceramides and Astaxanthin Extended with Powder $$$ (Skin); Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin & Nail Health	Dietary supplement: 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.; Dietary supplement: Astaxanthin; is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: ProofPilot
• Collaborators: Noho Health

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): February 9, 2021

Study Registration Dates

• First Submitted: January 25, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Pathological Conditions, Anatomical; Skin Diseases, Genetic; Hypotrichosis; Hair Diseases; Alopecia; Cutis Laxa
• Other Study ID Numbers: 2286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are currently no plans to make participant data available to other participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No