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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03312543
Recruitment Status : Completed
First Posted : October 17, 2017
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

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.

Condition or disease Intervention/treatment Phase
Skin Aging Device: Active Mask Device: Sham Mask Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : April 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

Arm Intervention/treatment
Experimental: Active Cell: Active Mask
Cleanser, Moisturizer, Active Mask
Device: 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.
Other Name: Active Light Therapy Mask

Sham Comparator: Sham Cell: Sham Mask
Cleanser, Moisturizer, Sham Mask
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.
Other Name: Sham Light Therapy Mask




Primary Outcome Measures :
  1. Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores [ Time Frame: Baseline to Week 12 ]
    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.

  2. Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 [ Time Frame: Baseline to Week 12 ]
    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.

  3. Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 [ Time Frame: Baseline to Week 12 ]
    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.

  4. Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 [ Time Frame: Baseline to Week 12 ]
    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.


Secondary Outcome Measures :
  1. Global Wrinkling - Change From Baseline to Week 1 [ Time Frame: 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.

  2. Global Wrinkling - Change From Baseline to Week 4 [ Time Frame: 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.

  3. Global Wrinkling - Change From Baseline to Week 24 [ Time Frame: 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.

  4. Fine Lines - Change From Baseline to Week 1 [ Time Frame: 1 week ]
    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.

  5. Fine Lines - Change From Baseline to Week 4 [ Time Frame: 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.

  6. Fine Lines - Change From Baseline to Week 12 [ Time Frame: 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.

  7. Fine Lines - Change From Baseline to Week 24 [ Time Frame: 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.

  8. Periorbital Wrinkles - Change From Baseline to Week 1 [ Time Frame: 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.

  9. Periorbital Wrinkles - Change From Baseline to Week 4 [ Time Frame: 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.

  10. Periorbital Wrinkles - Change From Baseline to Week 12 [ Time Frame: 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.

  11. Periorbital Wrinkles - Change From Baseline to Week 24 [ Time Frame: 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.

  12. Surface Roughness - Change From Baseline to Week 1 [ Time Frame: 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.

  13. Surface Roughness - Change From Baseline to Week 4 [ Time Frame: 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.

  14. Surface Roughness - Change From Baseline to Week 12 [ Time Frame: 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.

  15. Surface Roughness - Change From Baseline to Week 24 [ Time Frame: 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.

  16. Uneven Skin Tone - Change From Baseline to Week 1 [ Time Frame: 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.

  17. Uneven Skin Tone - Change From Baseline to Week 4 [ Time Frame: 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.

  18. Uneven Skin Tone - Change From Baseline to Week 12 [ Time Frame: 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.

  19. Uneven Skin Tone - Change From Baseline to Week 24 [ Time Frame: 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.

  20. Mottled Hyperpigmentation - Change From Baseline to Week 1 [ Time Frame: 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.

  21. Mottled Hyperpigmentation - Change From Baseline to Week 4 [ Time Frame: 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.

  22. Mottled Hyperpigmentation - Change From Baseline to Week 12 [ Time Frame: 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.

  23. Mottled Hyperpigmentation - Change From Baseline to Week 24 [ Time Frame: 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.

  24. Sallowness/Yellowing - Change From Baseline to Week 1 [ Time Frame: 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.

  25. Sallowness/Yellowing - Change From Baseline to Week 4 [ Time Frame: 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.

  26. Sallowness/Yellowing - Change From Baseline to Week 12 [ Time Frame: 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.

  27. Sallowness/Yellowing - Change From Baseline to Week 24 [ Time Frame: 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.

  28. Lack of Radiance - Change From Baseline to Week 1 [ Time Frame: 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.

  29. Lack of Radiance - Change From Baseline to Week 4 [ Time Frame: 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.

  30. Lack of Radiance - Change From Baseline to Week 12 [ Time Frame: 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.

  31. Lack of Radiance - Change From Baseline to Week 24 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312543


Locations
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United States, Pennsylvania
KGL Skin Study Center, LLC
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
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Principal Investigator: Stuart Lessin, M.D. KGL Skin Study Center, LLC
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Study Protocol  [PDF] September 26, 2017
Statistical Analysis Plan  [PDF] May 23, 2018


Publications:
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Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT03312543     History of Changes
Other Study ID Numbers: CO-170511132943-SACT
First Posted: October 17, 2017    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy