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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
124
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.
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.
KGL Skin Study Center, LLC
Broomall, Pennsylvania, United States
Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1
Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually.
Time frame: Baseline to Week 12
Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2
Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually.
Time frame: Baseline to Week 12
Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3
Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually.
Time frame: Baseline to Week 12
Global Wrinkling - Change From Baseline to Week 1
3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Global Wrinkling - Change From Baseline to Week 4
3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Global Wrinkling - Change From Baseline to Week 24
3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
Fine Lines - Change From Baseline to Week 1
3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: 1 week
Fine Lines - Change From Baseline to Week 4
3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Fine Lines - Change From Baseline to Week 12
3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Fine Lines - Change From Baseline to Week 24
3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
Periorbital Wrinkles - Change From Baseline to Week 1
3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Periorbital Wrinkles - Change From Baseline to Week 4
3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Periorbital Wrinkles - Change From Baseline to Week 12
3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Periorbital Wrinkles - Change From Baseline to Week 24
3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
Surface Roughness - Change From Baseline to Week 1
3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Surface Roughness - Change From Baseline to Week 4
3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Surface Roughness - Change From Baseline to Week 12
3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Surface Roughness - Change From Baseline to Week 24
3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Week 24
Uneven Skin Tone - Change From Baseline to Week 1
3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Uneven Skin Tone - Change From Baseline to Week 4
3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Uneven Skin Tone - Change From Baseline to Week 12
3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Uneven Skin Tone - Change From Baseline to Week 24
3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
Mottled Hyperpigmentation - Change From Baseline to Week 1
3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Mottled Hyperpigmentation - Change From Baseline to Week 4
3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Mottled Hyperpigmentation - Change From Baseline to Week 12
3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Mottled Hyperpigmentation - Change From Baseline to Week 24
3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
Sallowness/Yellowing - Change From Baseline to Week 1
3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Sallowness/Yellowing - Change From Baseline to Week 4
3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Sallowness/Yellowing - Change From Baseline to Week 12
3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Sallowness/Yellowing - Change From Baseline to Week 24
3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
Lack of Radiance - Change From Baseline to Week 1
3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time frame: Baseline to Week 1
Lack of Radiance - Change From Baseline to Week 4
3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time frame: Baseline to Week 4
Lack of Radiance - Change From Baseline to Week 12
3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time frame: Baseline to Week 12
Lack of Radiance - Change From Baseline to Week 24
3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time frame: Baseline to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.