Hair LossPhase 3NCT04249128
Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)
A Phase 3 study testing Vegetarian Collagen, Keratin and Ceramides in people with Hair Loss and Skin Laxity, run by ProofPilot at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Loss, Skin Laxity, Cosmetic Acne
- What is being tested?
- Vegetarian Collagen, Keratin and Ceramides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 9 Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Continental US
- ability and willingness to take selfies
Who cannot join
- skin diease
- use of retinoids
- known allergies
- significant facial hair
- medically relevant skin disease
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot Online App (https://p.proofpilot.com)
New York, New York, 10003
About this study
Official title: 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.
Read the 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.
- Conditions
- Hair Loss, Skin Laxity, Cosmetic Acne, Nails; Soft, Skin Aging
- Being tested
- Vegetarian Collagen, Keratin, Ceramides, Astaxanthin
- Medical subject headings
- Alopecia, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetarian CollagenDietary supplement
Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.
KeratinDietary 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.
CeramidesDietary 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.
AstaxanthinDietary supplement
is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
| Study group | Role | What they receive |
|---|---|---|
| Veg Collagen & Keratin Free (Hair Skin Nails) | Experimental | Participants will receive a free 3 month supply of Collagen \& Keratin for Hair, Skin \& Nail Health Receives: 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 Receives: Dietary Supplement: Vegetarian Collagen; Dietary Supplement: Keratin |
| Veg Collagen & Keratin $$$ (Hair Skin Nails) | Experimental | Participants will receive a paid 3-month supply of Collagen \& Keratin for Hair, Skin \& Nail Health Receives: Dietary Supplement: Vegetarian Collagen; Dietary Supplement: Keratin |
| Veg Collagen Extended with Powder $$$ (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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Ceramides; Dietary Supplement: Astaxanthin |
| Ceramides and Astaxanthin $$$ (Skin) | Experimental | Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin \& Nail Health Receives: Dietary Supplement: Ceramides; Dietary Supplement: Astaxanthin |
| Ceramides and Astaxanthin Extended with Powder $$$ (Skin) | Experimental | Participants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin \& Nail Health Receives: Dietary Supplement: Ceramides; Dietary Supplement: Astaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: weekly
Paid versus unpaid particpatnt adherence
Comparison of arms with the same intervention, but one paid, one not, to assess impact on adherence
Measured: 30 and 90 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start15 Jan 2020
- Primary completion28 Jan 2021
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Noho Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249128
- Sponsor's protocol ID
- 2286
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to make participant data available to other participants.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Derm Aid Study
- ClinicalTrials.gov ID
- NCT04249128
- Acronym / sponsor ID
- 2286
- Conditions
- Hair Loss, Skin Laxity, Cosmetic Acne, Nails; Soft, Skin Aging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Noho Health
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Veg Collagen & Keratin Free (Hair Skin Nails) | Experimental | Dietary Supplement: Vegetarian Collagen, Dietary Supplement: KeratinParticipants will receive a free 3 month supply of Collagen \& Keratin for Hair, Skin \& Nail Health |
| Veg Collagen Extended with Powder Free (Hair Skin Nails) | Experimental | Dietary Supplement: Vegetarian Collagen, Dietary Supplement: KeratinParticipants will receive a free 3- month supply of Collagen \& Keratin for Hair, Skin \& Nail Health extended with a pro-berry powder |
| Veg Collagen & Keratin $$$ (Hair Skin Nails) | Experimental | Dietary Supplement: Vegetarian Collagen, Dietary Supplement: KeratinParticipants will receive a paid 3-month supply of Collagen \& Keratin for Hair, Skin \& Nail Health |
| Veg Collagen Extended with Powder $$$ (Hair Skin Nails) | Experimental | Dietary Supplement: Vegetarian Collagen, Dietary Supplement: KeratinParticipants will receive a paid 3-month supply of Collagen \& Keratin extended with pro-berry powder for Hair, Skin \& Nail Health |
| Ceramides and Astaxanthin Free (Skin) | Experimental | Dietary Supplement: Ceramides, Dietary Supplement: AstaxanthinParticipants will receive a free 3-month supply of ceramides and Astaxanthin for Hair, Skin \& Nail Health |
| Ceramides and Astaxanthin Extended with Powder Free (Skin) | Experimental | Dietary Supplement: Ceramides, Dietary Supplement: AstaxanthinParticipants will receive a free 3-month supply of Ceramides and Astaxanthin for Hair, Skin \& Nail Health |
| Ceramides and Astaxanthin $$$ (Skin) | Experimental | Dietary Supplement: Ceramides, Dietary Supplement: AstaxanthinParticipants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin \& Nail Health |
| Ceramides and Astaxanthin Extended with Powder $$$ (Skin) | Experimental | Dietary Supplement: Ceramides, Dietary Supplement: AstaxanthinParticipants will receive a paid 3-month supply of Ceramides and Astaxanthin extended with pro-berry powder for Hair, Skin \& Nail Health |
Who may qualify
- Ages
- 26 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Continental US
- ability and willingness to take selfies
Key exclusion criteria (5 listed)
- skin diease
- use of retinoids
- known allergies
- significant facial hair
- medically relevant skin disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetarian CollagenCollagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen. | Dietary supplement | 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) |
| KeratinKeratin (/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. | Dietary supplement | 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) |
| CeramidesCeramides 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 | Ceramides and Astaxanthin $$$ (Skin), Ceramides and Astaxanthin Extended with Powder $$$ (Skin), Ceramides and Astaxanthin Extended with Powder Free (Skin), Ceramides and Astaxanthin Free (Skin) |
| Astaxanthinis a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon. | Dietary supplement | Ceramides and Astaxanthin $$$ (Skin), Ceramides and Astaxanthin Extended with Powder $$$ (Skin), Ceramides and Astaxanthin Extended with Powder Free (Skin), Ceramides and Astaxanthin Free (Skin) |
Primary outcome
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.
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No. There are currently no plans to make participant data available to other participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vegetarian Collagen, Keratin and Ceramides in people with Hair Loss and Skin Laxity, run by ProofPilot at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Self-Report Skin, Hair & Nail Health and Satisfaction (time frame: Baseline, 30 Day, 60 Day and 90Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.