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

NCT04249128 | Completed Phase 3 DMC

• 1 other identifier: 2286
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (8)

Veg Collagen & Keratin Free (Hair Skin Nails)

EXPERIMENTAL

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

Dietary Supplement: Vegetarian Collagen; Dietary Supplement: Keratin

Veg Collagen Extended with Powder Free (Hair Skin Nails)

EXPERIMENTAL

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; Dietary Supplement: Keratin

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

EXPERIMENTAL

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

Dietary Supplement: Vegetarian Collagen; Dietary Supplement: Keratin

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

EXPERIMENTAL

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; Dietary Supplement: Keratin

Ceramides and Astaxanthin Free (Skin)

EXPERIMENTAL

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

Dietary Supplement: Ceramides; Dietary Supplement: Astaxanthin

Ceramides and Astaxanthin Extended with Powder Free (Skin)

EXPERIMENTAL

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

Dietary Supplement: Ceramides; Dietary Supplement: Astaxanthin

Ceramides and Astaxanthin $$$ (Skin)

EXPERIMENTAL

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; Dietary Supplement: Astaxanthin

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

EXPERIMENTAL

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; Dietary Supplement: Astaxanthin

Interventions

Vegetarian Collagen DIETARY_SUPPLEMENT

Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.

Veg Collagen & Keratin $$$ (Hair Skin Nails); Veg Collagen & Keratin Free (Hair Skin Nails); Veg Collagen Extended with Powder $$$ (Hair Skin Nails); Veg Collagen Extended with Powder Free (Hair Skin Nails)

Keratin DIETARY_SUPPLEMENT

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.

Veg Collagen & Keratin $$$ (Hair Skin Nails); Veg Collagen & Keratin Free (Hair Skin Nails); Veg Collagen Extended with Powder $$$ (Hair Skin Nails); Veg Collagen Extended with Powder Free (Hair Skin Nails)

Ceramides DIETARY_SUPPLEMENT

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.

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

Astaxanthin DIETARY_SUPPLEMENT

is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.

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

Eligibility Criteria

• Age: 26 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Continental US
• ability and willingness to take selfies

You may not qualify if:

• skin diease
• use of retinoids
• known allergies
• significant facial hair
• medically relevant skin disease

Sponsors & Collaborators

• ProofPilot: lead
• Noho Health: collaborator

Study Sites (1)

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

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Alopecia; Cutis Laxa

Interventions

Keratins; Ceramides; astaxanthine

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Intermediate Filament Proteins; Biopolymers; Polymers; Macromolecular Substances; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Scleroproteins; Amides; Organic Chemicals; Neutral Glycosphingolipids; Glycosphingolipids; Glycolipids; Glycoconjugates; Carbohydrates; Lipids; Sphingolipids; Membrane Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: January 30, 2020
• Study Start: January 15, 2020
• Primary Completion: January 28, 2021
• Study Completion: February 9, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)