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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2018-04-06

Brief Summary

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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.

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Detailed Description

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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 of elasticity. Ablative techniques, such as dermabrasion, deep chemical peels, and ablative laser resurfacing of various wavelengths, are well documented to alleviate the signs of photodamage. However, such techniques often require significant post-treatment care and have higher risk profiles than other treatments, with potential side effects including erythema, pigmentation issues, infection, and possible scarring. They may be poorly tolerated by patients who dislike the discomfort, wound care, and prolonged downtime involved.

Non-ablative skin rejuvenation procedures are also effective for improving the appearance of photodamaged skin and are becoming increasingly popular because of their minimal downtime and increased safety. These procedures include intense pulsed light systems, non-ablative lasers, and monochromatic light boxes, which can target facial rhytids, irregular pigmentation, telangiectasia, and skin laxity. Unfortunately, such techniques can be expensive and their use is primarily limited to clinical settings.

However, the light-emitting diode (LED) is a novel light source that is well-suited for non-ablative phototherapy that can be utilized at home for a relatively low price. This study will evaluate the efficacy and tolerance of an LED-based light therapy mask as compared to a sham mask in subjects seeking anti-aging benefits.

Conditions

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Skin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active Cell: Active Mask

Cleanser, Moisturizer, Active Mask

Group Type EXPERIMENTAL

Active Mask

Intervention Type DEVICE

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.

Sham Cell: Sham Mask

Cleanser, Moisturizer, Sham Mask

Group Type SHAM_COMPARATOR

Sham Mask

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Active Light Therapy Mask Sham Light Therapy Mask

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No