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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Derm Aid Study

Conditions
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Hair Loss, Skin Laxity, Cosmetic Acne, Nails; Soft, Skin Aging

Intervention / Treatment
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* Dietary Supplement: Vegetarian Collagen
* Dietary Supplement: Keratin
* Dietary Supplement: Ceramides
* Dietary Supplement: Astaxanthin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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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 |