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

• 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: Johnson & Johnson Consumer Inc. (J&JCI)
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Pennsylvania

KGL Skin Study Center, LLC

Broomall, Pennsylvania, United States, 19008

Sponsors and Collaborators

Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

• 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

More Information

Publications:

Fitzpatrick RE. Laser resurfacing of rhytides. Dermatol Clin. 1997 Jul;15(3):431-47. doi: 10.1016/s0733-8635(05)70452-6.

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.

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.

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.

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.

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.

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT03312543
• Other Study ID Numbers: CO-170511132943-SACT
• First Posted: October 17, 2017
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• 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