N/A
N=124
Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles
Skin Aging
Bottom Line
View on ClinicalTrials.gov: NCT03312543 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
Mar 2019
Primary outcome: Primary: Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores — 0.18; 0.30 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Mask (Device); Sham Mask (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores |
0.18; 0.30 | <0.001 sig |
| PRIMARY Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 |
0.20; 0.22 | <0.001 sig |
| PRIMARY Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 |
-0.03; 0.21 | 0.627 |
| PRIMARY Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 |
0.36; 0.47 | <0.001 sig |
| SECONDARY Global Wrinkling - Change From Baseline to Week 1 |
0.03; 0.04 | — |
| SECONDARY Global Wrinkling - Change From Baseline to Week 4 |
0.09; 0.09 | — |
| SECONDARY Global Wrinkling - Change From Baseline to Week 24 |
0.24; 0.30 | — |
| SECONDARY Fine Lines - Change From Baseline to Week 1 |
0.01; 0.05 | — |
| SECONDARY Fine Lines - Change From Baseline to Week 4 |
0.08; 0.13 | — |
| SECONDARY Fine Lines - Change From Baseline to Week 12 |
0.23; 0.32 | — |
| SECONDARY Fine Lines - Change From Baseline to Week 24 |
0.28; 0.29 | — |
| SECONDARY Periorbital Wrinkles - Change From Baseline to Week 1 |
0.00; 0.01 | — |
| SECONDARY Periorbital Wrinkles - Change From Baseline to Week 4 |
0.10; 0.10 | — |
| SECONDARY Periorbital Wrinkles - Change From Baseline to Week 12 |
0.15; 0.30 | — |
| SECONDARY Periorbital Wrinkles - Change From Baseline to Week 24 |
0.22; 0.29 | — |
| SECONDARY Surface Roughness - Change From Baseline to Week 1 |
0.35; 0.38 | — |
| SECONDARY Surface Roughness - Change From Baseline to Week 4 |
0.79; 0.76 | — |
| SECONDARY Surface Roughness - Change From Baseline to Week 12 |
0.94; 0.89 | — |
| SECONDARY Surface Roughness - Change From Baseline to Week 24 |
1.12; 0.95 | — |
| SECONDARY Uneven Skin Tone - Change From Baseline to Week 1 |
0.04; 0.06 | — |
| SECONDARY Uneven Skin Tone - Change From Baseline to Week 4 |
0.18; 0.23 | — |
| SECONDARY Uneven Skin Tone - Change From Baseline to Week 12 |
0.36; 0.49 | — |
| SECONDARY Uneven Skin Tone - Change From Baseline to Week 24 |
0.44; 0.52 | — |
| SECONDARY Mottled Hyperpigmentation - Change From Baseline to Week 1 |
-0.01; -0.02 | — |
| SECONDARY Mottled Hyperpigmentation - Change From Baseline to Week 4 |
0.10; 0.15 | — |
| SECONDARY Mottled Hyperpigmentation - Change From Baseline to Week 12 |
0.22; 0.39 | — |
| SECONDARY Mottled Hyperpigmentation - Change From Baseline to Week 24 |
0.25; 0.31 | — |
| SECONDARY Sallowness/Yellowing - Change From Baseline to Week 1 |
-0.01; 0.01 | — |
| SECONDARY Sallowness/Yellowing - Change From Baseline to Week 4 |
0.12; 0.12 | — |
| SECONDARY Sallowness/Yellowing - Change From Baseline to Week 12 |
0.23; 0.33 | — |
| SECONDARY Sallowness/Yellowing - Change From Baseline to Week 24 |
0.29; 0.32 | — |
| SECONDARY Lack of Radiance - Change From Baseline to Week 1 |
0.07; 0.13 | — |
| SECONDARY Lack of Radiance - Change From Baseline to Week 4 |
0.28; 0.37 | — |
| SECONDARY Lack of Radiance - Change From Baseline to Week 12 |
0.41; 0.55 | — |
| SECONDARY Lack of Radiance - Change From Baseline to Week 24 |
0.54; 0.59 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03312543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.