Skin InflammationNCT04471896
Joovvin' for Your Skin Health Study
A study testing Joovv Mini in people with Skin Inflammation and Acne, run by ProofPilot at 1 site in United States.
Trial summary
Sixty day single arm trial examining self-report and remote dermatology assessment of cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device (the Joovv Mini) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation, Acne, Skin Diseases
- What is being tested?
- Joovv Mini
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Feb 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willingness to use device for 60 days
- willingness to place security deposit on device of $149.99
- US resident with an address than can accept UPS deliveries
- 18 years old
- no serious medical conditions
- no medically treatable skin diseases
- willingness to take a selfie with mobile phone
Who cannot join
- Retinoid use
- prior use of light therapy within the past 6 months
- pregnant or nursing
- dietary supplements for skin, hair or nail health
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot (Virtual Study: https://p.proofpilot.com)
New York, New York, 10003
About this study
Official title: Examining the Impact of Infrared Light Therapy Device on Cosmetic Skin Health
Sixty day single arm trial examining self-report and remote dermatology assessment of cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device (the Joovv Mini)
- Conditions
- Skin Inflammation, Acne, Skin Diseases, Dermatological Non-Disease, Skin Condition, Eczema
- Being tested
- Joovv Mini
- Medical subject headings
- Dermatitis, Acne Vulgaris, Skin Diseases, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joovv MiniDevice
Also called Infrared light therapy device
Infrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive an infrared therapy device for use at home for 60 days. Participants will use the device every day for 10-20 minutes during the intervention period. Receives: Device: Joovv Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded Dermatology Assessment of Facial Skin Health
Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau \& custom wrinkle selfie scale
Measured: 60 day
Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
A custom self report survey on cosmetic skin health satisfaction
Measured: 60 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joovv
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471896
- Sponsor's protocol ID
- 2521
- Status last verified
- Feb 2021
- First submitted
- 11 Jul 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Infrared Light Therapy Device on Cosmetic Skin Health
- ClinicalTrials.gov ID
- NCT04471896
- Acronym / sponsor ID
- 2521
- Conditions
- Skin Inflammation, Acne, Skin Diseases, Dermatological Non-Disease, Skin Condition, Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Joovv
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 15 Jul 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.
Sixty day single arm trial examining self-report and remote dermatology assessment of cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device (the Joovv Mini)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Joovv MiniParticipants will receive an infrared therapy device for use at home for 60 days. Participants will use the device every day for 10-20 minutes during the intervention period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- willingness to use device for 60 days
- willingness to place security deposit on device of $149.99
- US resident with an address than can accept UPS deliveries
- 18 years old
- no serious medical conditions
Key exclusion criteria (4 listed)
- Retinoid use
- prior use of light therapy within the past 6 months
- pregnant or nursing
- dietary supplements for skin, hair or nail health
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 |
|---|---|---|
| Joovv MiniAlso: Infrared light therapy deviceInfrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini. | Device | Treatment Arm |
Primary outcome
Blinded Dermatology Assessment of Facial Skin Health
Time frame: 60 day
Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau \& custom wrinkle selfie scale
Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
Time frame: 60 day
A custom self report survey on cosmetic skin health satisfaction
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 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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 study testing Joovv Mini in people with Skin Inflammation and Acne, 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 7 inclusion and 4 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 12 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.
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?
Blinded Dermatology Assessment of Facial Skin Health (time frame: 60 day). The study lists 2 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 12 Feb 2021.