Status:

COMPLETED

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

Lead Sponsor:

Johnson & Johnson Consumer Inc. (J&JCI)

Conditions:

Skin Aging

Eligibility:

FEMALE

35-70 years

Phase:

NA

Brief 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 ina...

Detailed Description

Exposure to sunlight and artificial light sources containing ultraviolet (UV) radiation is known to accelerate the skin's aging process, resulting in unwanted wrinkles, irregular skin tone, and loss o...

Eligibility Criteria

Inclusion

  • Has mild to moderate brown spots
  • Has moderate to severe facial wrinkling
  • Able to read, write, speak, and understand English
  • In general good health
  • If capable of having a child: must agree to practice a medically acceptable form of birth control.
  • Intends to complete the study and willing to follow all study directions.

Exclusion

  • Allergies/sensitivity to skincare products or the test product ingredients
  • Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results.
  • Is taking medication that may cause skin sensitivity to light
  • Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
  • Has a facial skin condition (e.g. rosacea, acne, eczema, etc.) that could increase health risk to the subject or confuse the study results.
  • Has skin cancer or a history of skin cancer.
  • Has an immune deficiency disorder, active hepatitis, or an autoimmune disease.
  • Has an uncontrolled metabolic condition (e.g. diabetes, hypertension)
  • Is pregnant, nursing, or planning to become pregnant.
  • Plans to start or change a hormone replacement therapy during the study.
  • Has participated in another study in the past 30 days or plans to during the study.
  • Is an employee or relative of the Study Site, Investigator, or Sponsor.

Key Trial Info

Start Date :

October 9 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 6 2018

Estimated Enrollment :

124 Patients enrolled

Trial Details

Trial ID

NCT03312543

Start Date

October 9 2017

End Date

April 6 2018

Last Update

March 5 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

KGL Skin Study Center, LLC

Broomall, Pennsylvania, United States, 19008