Back to resultsJoovvin' for Your Skin Health Study
Primary Purpose
Skin Inflammation, Acne, Skin Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joovv Mini
Sponsored by
About this trial
This is an interventional treatment trial for Skin Inflammation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Retinoid use
- prior use of light therapy within the past 6 months
- pregnant or nursing
- dietary supplements for skin, hair or nail health
Sites / Locations
- ProofPilot (Virtual Study: https://p.proofpilot.com)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
A custom self report survey on cosmetic skin health satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT04471896
First Posted
July 11, 2020
Last Updated
February 9, 2021
Sponsor
ProofPilot
Collaborators
Joovv
1. Study Identification
Unique Protocol Identification Number
NCT04471896
Brief Title
Joovvin' for Your Skin Health Study
Official Title
Examining the Impact of Infrared Light Therapy Device on Cosmetic Skin Health
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Joovv
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Inflammation, Acne, Skin Diseases, Dermatological Non-Disease, Skin Condition, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Joovv Mini
Other Intervention Name(s)
Infrared light therapy device
Intervention Description
Infrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini.
Primary Outcome Measure Information:
Title
Blinded Dermatology Assessment of Facial Skin Health
Description
Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau & custom wrinkle selfie scale
Time Frame
60 day
Title
Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
Description
A custom self report survey on cosmetic skin health satisfaction
Time Frame
60 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Retinoid use
prior use of light therapy within the past 6 months
pregnant or nursing
dietary supplements for skin, hair or nail health
Facility Information:
Facility Name
ProofPilot (Virtual Study: https://p.proofpilot.com)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Joovvin' for Your Skin Health Study
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