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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249128
Recruitment Status : Completed
First Posted : January 30, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Noho Health
Information provided by (Responsible Party):
ProofPilot

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.

Condition or disease Intervention/treatment Phase
Hair Loss Skin Laxity Cosmetic Acne Nails; Soft Skin Aging Dietary Supplement: Vegetarian Collagen Dietary Supplement: Keratin Dietary Supplement: Ceramides Dietary Supplement: Astaxanthin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, 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
Primary Purpose: Prevention
Official Title: The Derm Aid Study
Actual Study Start Date : January 15, 2020
Actual Primary Completion Date : January 28, 2021
Actual Study Completion Date : February 9, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Changes in Self-Report Skin, Hair & Nail Health and Satisfaction [ Time Frame: 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.

  2. Blinded Dermatology Assessment of Facial Skin health [ Time Frame: 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

  3. Participant Acceptability [ Time Frame: 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.

  4. Paid versus unpaid particpatnt adherence [ Time Frame: 30 and 90 Day ]
    Comparison of arms with the same intervention, but one paid, one not, to assess impact on adherence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   26 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249128


Locations
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United States, New York
ProofPilot Online App (https://p.proofpilot.com)
New York, New York, United States, 10003
Sponsors and Collaborators
ProofPilot
Noho Health
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Responsible Party: ProofPilot
ClinicalTrials.gov Identifier: NCT04249128    
Other Study ID Numbers: 2286
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are currently no plans to make participant data available to other participants.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cutis Laxa
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases