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Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles

NCT03312543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-03-05

Study results available
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Summary

This research study will test how well a light therapy mask works for women with mild to moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared to a "sham" or inactive investigational light therapy mask. The study will also test if the light therapy mask causes any irritation. For the first 12 weeks of the study, participants will use the assigned mask, along with a provided cleanser and sunscreen. For the second 12 weeks of the study, participants will use just the cleanser and sunscreen.

Conditions

  • Skin Aging

Interventions

DEVICE

Active Mask

A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the active light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.

DEVICE

Sham Mask

A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the sham light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Stuart Lessin, M.D. · KGL Skin Study Center, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2018-01-12
Completion
2018-04-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03312543 on ClinicalTrials.gov