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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

CompletedNA

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Conditions: Skin Aging

Interventions: Active Mask, Sham Mask

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 35 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (1)

Broomall, Pennsylvania, United States