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

Primary Purpose

Hair Loss, Skin Laxity, Cosmetic Acne

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vegetarian Collagen
Keratin
Ceramides
Astaxanthin
Sponsored by
ProofPilot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hair Loss

Eligibility Criteria

26 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ProofPilot Online App (https://p.proofpilot.com)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Veg Collagen & Keratin Free (Hair Skin Nails)

Veg Collagen Extended with Powder Free (Hair Skin Nails)

Veg Collagen & Keratin $$$ (Hair Skin Nails)

Veg Collagen Extended with Powder $$$ (Hair Skin Nails)

Ceramides and Astaxanthin Free (Skin)

Ceramides and Astaxanthin Extended with Powder Free (Skin)

Ceramides and Astaxanthin $$$ (Skin)

Ceramides and Astaxanthin Extended with Powder $$$ (Skin)

Arm Description

Participants will receive a free 3 month supply of Collagen & Keratin for Hair, Skin & Nail Health

Participants will receive a free 3- month supply of Collagen & Keratin for Hair, Skin & Nail Health extended with a pro-berry powder

Participants will receive a paid 3-month supply of Collagen & Keratin for Hair, Skin & Nail Health

Participants will receive a paid 3-month supply of Collagen & Keratin extended with pro-berry powder for Hair, Skin & Nail Health

Participants will receive a free 3-month supply of ceramides and Astaxanthin for Hair, Skin & Nail Health

Participants will receive a free 3-month supply of Ceramides and Astaxanthin for Hair, Skin & Nail Health

Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin & Nail Health

Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin & Nail Health

Outcomes

Primary Outcome Measures

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.
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
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.
Paid versus unpaid particpatnt adherence
Comparison of arms with the same intervention, but one paid, one not, to assess impact on adherence

Secondary Outcome Measures

Full Information

First Posted
January 25, 2020
Last Updated
February 9, 2021
Sponsor
ProofPilot
Collaborators
Noho Health
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1. Study Identification

Unique Protocol Identification Number
NCT04249128
Brief Title
Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)
Official Title
The Derm Aid Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Noho Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss, Skin Laxity, Cosmetic Acne, Nails; Soft, Skin Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Veg Collagen & Keratin Free (Hair Skin Nails)
Arm Type
Experimental
Arm Description
Participants will receive a free 3 month supply of Collagen & Keratin for Hair, Skin & Nail Health
Arm Title
Veg Collagen Extended with Powder Free (Hair Skin Nails)
Arm Type
Experimental
Arm Description
Participants will receive a free 3- month supply of Collagen & Keratin for Hair, Skin & Nail Health extended with a pro-berry powder
Arm Title
Veg Collagen & Keratin $$$ (Hair Skin Nails)
Arm Type
Experimental
Arm Description
Participants will receive a paid 3-month supply of Collagen & Keratin for Hair, Skin & Nail Health
Arm Title
Veg Collagen Extended with Powder $$$ (Hair Skin Nails)
Arm Type
Experimental
Arm Description
Participants will receive a paid 3-month supply of Collagen & Keratin extended with pro-berry powder for Hair, Skin & Nail Health
Arm Title
Ceramides and Astaxanthin Free (Skin)
Arm Type
Experimental
Arm Description
Participants will receive a free 3-month supply of ceramides and Astaxanthin for Hair, Skin & Nail Health
Arm Title
Ceramides and Astaxanthin Extended with Powder Free (Skin)
Arm Type
Experimental
Arm Description
Participants will receive a free 3-month supply of Ceramides and Astaxanthin for Hair, Skin & Nail Health
Arm Title
Ceramides and Astaxanthin $$$ (Skin)
Arm Type
Experimental
Arm Description
Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin & Nail Health
Arm Title
Ceramides and Astaxanthin Extended with Powder $$$ (Skin)
Arm Type
Experimental
Arm Description
Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin & Nail Health
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetarian Collagen
Intervention Description
Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.
Intervention Type
Dietary Supplement
Intervention Name(s)
Keratin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ceramides
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Astaxanthin
Intervention Description
is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
Primary Outcome Measure Information:
Title
Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
Description
A custom self-report survey for participants to self-assess their satisfaction on skin, hair and nail status.
Time Frame
Baseline, 30 Day, 60 Day and 90Day
Title
Blinded Dermatology Assessment of Facial Skin health
Description
Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau & customer wrinkle selfie scale
Time Frame
Baseline 45 day and 90 day
Title
Participant Acceptability
Description
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.
Time Frame
weekly
Title
Paid versus unpaid particpatnt adherence
Description
Comparison of arms with the same intervention, but one paid, one not, to assess impact on adherence
Time Frame
30 and 90 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
ProofPilot Online App (https://p.proofpilot.com)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are currently no plans to make participant data available to other participants.

Learn more about this trial

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

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