Skin Aging Clinical Trial
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
Verified date | February 2019 |
Source | Johnson & Johnson Consumer and Personal Products Worldwide |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | April 6, 2018 |
Est. primary completion date | January 12, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | KGL Skin Study Center, LLC | Broomall | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer Inc. (J&JCI) |
United States,
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. — View Citation
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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. — View Citation
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McCullough JL, Kelly KM. Prevention and treatment of skin aging. Ann N Y Acad Sci. 2006 May;1067:323-31. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to Week 12 | |
Primary | 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. | Baseline to Week 12 | |
Primary | 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. | Baseline to Week 12 | |
Primary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 24 | |
Secondary | 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. | 1 week | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 24 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 24 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Week 24 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 24 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 24 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 24 | |
Secondary | 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. | Baseline to Week 1 | |
Secondary | 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. | Baseline to Week 4 | |
Secondary | 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. | Baseline to Week 12 | |
Secondary | 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. | Baseline to Week 24 |
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