Clinical trial NCT03312543: Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles
Official title: A Randomized, Evaluator-Blinded Clinical Study to Evaluate the Efficacy and Tolerability of an Investigational Light Therapy Mask on Subjects With Mild to Moderate Mottled Hyperpigmentation and Moderate to Severe Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 124
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

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.

Primary outcomes:
measure: Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
timeFrame: Baseline to Week 12
measure: Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1
timeFrame: Baseline to Week 12
measure: Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2
timeFrame: Baseline to Week 12
measure: Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Global Wrinkling - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Global Wrinkling - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Global Wrinkling - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Fine Lines - Change From Baseline to Week 1
timeFrame: 1 week
measure: Fine Lines - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Fine Lines - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Fine Lines - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Periorbital Wrinkles - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Periorbital Wrinkles - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Periorbital Wrinkles - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Periorbital Wrinkles - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Surface Roughness - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Surface Roughness - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Surface Roughness - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Surface Roughness - Change From Baseline to Week 24
timeFrame: Week 24
measure: Uneven Skin Tone - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Uneven Skin Tone - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Uneven Skin Tone - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Uneven Skin Tone - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Mottled Hyperpigmentation - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Mottled Hyperpigmentation - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Mottled Hyperpigmentation - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Mottled Hyperpigmentation - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Sallowness/Yellowing - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Sallowness/Yellowing - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Sallowness/Yellowing - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Sallowness/Yellowing - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Lack of Radiance - Change From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Lack of Radiance - Change From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Lack of Radiance - Change From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Lack of Radiance - Change From Baseline to Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Broomall
country: United States
facility: KGL Skin Study Center, LLC
state: Pennsylvania
Study officials:
affiliation: KGL Skin Study Center, LLC
name: Stuart Lessin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: McCullough JL, Kelly KM. Prevention and treatment of skin aging. Ann N Y Acad Sci. 2006 May;1067:323-31. doi: 10.1196/annals.1354.044.
citation: Weiss RA, McDaniel DH, Geronemus RG. Review of nonablative photorejuvenation: reversal of the aging effects of the sun and environmental damage using laser and light sources. Semin Cutan Med Surg. 2003 Jun;22(2):93-106. doi: 10.1053/sder.2003.50008.
citation: Kim JW. Clinical trial of nonthermal 633 nm Omnilux LED array for renewal of photoaging: clinical surface profile metric results. Korea Soc Las Med Surg. 2005; 9:69-76.
citation: Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402.
citation: Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-51.