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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04245527
Other study ID # 2216
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 31, 2020
Est. completion date June 1, 2020

Study information

Verified date January 2020
Source ProofPilot
Contact Matthew M Amsden
Phone 3232844626
Email crew@proofpilot.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

8-week pilot study looking at the impact of Joovv's infrared photo modulation product on male and female hormone levels.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- United States resident

Exclusion Criteria:

- current Joovv or other photomodulation therapy user

- under medical supervision for medically treatable illness

- significant travel during study period

- use of birth control

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Joovv Infrared Light Device
Joovv is the leading manufacturer of personal, in-home red light therapy devices

Locations

Country Name City State
United States ProofPilot (Virtual Study: https://p.proofpilot.com) New York New York

Sponsors (2)

Lead Sponsor Collaborator
ProofPilot Joovv

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Testosterone Change in males, change from baseline to week 8 baseline to week 8
Primary change of thyroid-stimulating hormone (TSH) in females change in estrogen and progesterone from baseline to week 8 baseline to week 8
Primary Self report general wellness series of questions at baseline and week 8 on general wellness (modified Short Form-36) baseline to week 8
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