Skin AgingNCT03312543

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

A study testing Active Mask in people with Skin Aging, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 70 years, women only
Conditions the study is for: Skin Aging
What is being tested?: Active Mask
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 1 siteUnited States
Study dates: 9 Oct 2017to 6 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

KGL Skin Study Center, LLC
Broomall, Pennsylvania, 19008

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Skin Aging
Being tested: Active Mask, Sham Mask
Keywords: Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active MaskDevice
Also called Active Light Therapy 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.
Sham MaskDevice
Also called Sham Light Therapy 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.

Study groups in NCT03312543
Study group	Role	What they receive
Active Cell: Active Mask	Experimental	Cleanser, Moisturizer, Active Mask Receives: Device: Active Mask
Sham Cell: Sham Mask	Sham comparator	Cleanser, Moisturizer, Sham Mask Receives: Device: Sham Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12

Secondary outcomes (31)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 20176 Apr 2018

First posted17 Oct 2017
Study start9 Oct 2017
Primary completion12 Jan 2018
Study completion6 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Skin AgingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03312543
Sponsor's protocol ID: CO-170511132943-SACT
Status last verified: Feb 2019
First submitted: 6 Oct 2017
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Fitzpatrick RE. Laser resurfacing of rhytides. Dermatol Clin. 1997 Jul;15(3):431-47. doi: 10.1016/s0733-8635(05)70452-6.
PubMed 9189680
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.
PubMed 16804006
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.
PubMed 12877228
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.
PubMed 8629842
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.
PubMed 1550366

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03312543
Acronym / sponsor ID: CO-170511132943-SACT
Conditions: Skin Aging
Keywords: Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 9 Oct 2017 (actual)
Primary completion: 12 Jan 2018 (actual)
Study completion: 6 Apr 2018 (actual)
First posted: 17 Oct 2017 (actual)
Results: Posted 5 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Cell: Active Mask	Experimental	Device: Active MaskCleanser, Moisturizer, Active Mask
Sham Cell: Sham Mask	Sham comparator	Device: Sham MaskCleanser, Moisturizer, Sham Mask

Who may qualify

Ages: 35 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active MaskAlso: Active Light Therapy MaskA 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.	Device	Active Cell: Active Mask
Sham MaskAlso: Sham Light Therapy MaskA 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.	Device	Sham Cell: Sham Mask

Primary outcome

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.
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.
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.
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.

31 secondary outcomes

Global Wrinkling - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Global Wrinkling - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Global Wrinkling - Change From Baseline to Week 24
Time frame: Baseline to Week 24
Fine Lines - Change From Baseline to Week 1
Time frame: 1 week
Fine Lines - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Fine Lines - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Fine Lines - Change From Baseline to Week 24
Time frame: Baseline to Week 24
Periorbital Wrinkles - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Periorbital Wrinkles - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Periorbital Wrinkles - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Periorbital Wrinkles - Change From Baseline to Week 24
Time frame: Baseline to Week 24
Surface Roughness - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Surface Roughness - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Surface Roughness - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Surface Roughness - Change From Baseline to Week 24
Time frame: Week 24
Uneven Skin Tone - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Uneven Skin Tone - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Uneven Skin Tone - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Uneven Skin Tone - Change From Baseline to Week 24
Time frame: Baseline to Week 24
Mottled Hyperpigmentation - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Mottled Hyperpigmentation - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Mottled Hyperpigmentation - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Mottled Hyperpigmentation - Change From Baseline to Week 24
Time frame: Baseline to Week 24
Sallowness/Yellowing - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Sallowness/Yellowing - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Sallowness/Yellowing - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Sallowness/Yellowing - Change From Baseline to Week 24
Time frame: Baseline to Week 24
Lack of Radiance - Change From Baseline to Week 1
Time frame: Baseline to Week 1
Lack of Radiance - Change From Baseline to Week 4
Time frame: Baseline to Week 4
Lack of Radiance - Change From Baseline to Week 12
Time frame: Baseline to Week 12
Lack of Radiance - Change From Baseline to Week 24
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 5 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Cell: Sham Mask	61	60
Active Cell: Active Mask	63	59

Primary outcome: Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Sham Cell: Sham Mask n = 59	Active Cell: Active Mask n = 57
Value	0.18 (0.328)	0.30 (0.341)

Sham Cell: Sham Mask: Mean Difference (Net): 0.18 (95% CI 0.09 to 0.26), p <0.001, t-test, 2 sided
Active Cell: Active Mask: Mean Difference (Net): 0.30 (95% CI 0.21 to 0.39), p <0.001, t-test, 2 sided
Sham Cell: Sham Mask vs Active Cell: Active Mask: Mean Difference (Net): 0.14 (95% CI 0.02 to 0.25), p = 0.025, ANCOVA

Population analysed: Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.

Primary outcome: Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Units on a scale.

Measure	Sham Cell: Sham Mask n = 59	Active Cell: Active Mask n = 57
Value	0.20 (0.349)	0.22 (0.328)

Sham Cell: Sham Mask: Mean Difference (Net): 0.20 (95% CI 0.11 to 0.29), p <0.001, t-test, 2 sided
Active Cell: Active Mask: Mean Difference (Net): 0.22 (95% CI 0.13 to 0.31), p <0.001, t-test, 2 sided
Sham Cell: Sham Mask vs Active Cell: Active Mask: Mean Difference (Net): 0.04 (95% CI -0.09 to 0.16), p = 0.540, ANCOVA

Primary outcome: Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Units on a scale.

Measure	Sham Cell: Sham Mask n = 59	Active Cell: Active Mask n = 57
Value	-0.03 (0.532)	0.21 (0.500)

Sham Cell: Sham Mask: Mean Difference (Net): -0.03 (95% CI -0.17 to 0.10), p = 0.627, t-test, 2 sided
Active Cell: Active Mask: Mean Difference (Net): 0.21 (95% CI 0.08 to 0.34), p = 0.002, t-test, 2 sided
Sham Cell: Sham Mask vs Active Cell: Active Mask: Mean Difference (Net): 0.24 (95% CI 0.06 to 0.42), p = 0.009, ANCOVA

Primary outcome: Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Units on a scale.

Measure	Sham Cell: Sham Mask n = 59	Active Cell: Active Mask n = 57
Value	0.36 (0.465)	0.47 (0.578)

Sham Cell: Sham Mask: Mean Difference (Net): 0.36 (95% CI 0.23 to 0.48), p <0.001, t-test, 2 sided
Active Cell: Active Mask: Mean Difference (Net): 0.47 (95% CI 0.32 to 0.63), p <0.001, t-test, 2 sided
Sham Cell: Sham Mask vs Active Cell: Active Mask: Mean Difference (Net): 0.11 (95% CI -0.07 to 0.30), p = 0.224, ANCOVA

31 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 24 unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting, but AEs/SAEs are shown in this posting for a collection period of approximately 6 months from last subject's visit (the time of this posting).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Cell: Sham Mask	0 of 60 (0%)	4 of 60 (6.7%)	0 of 60
Active Cell: Active Mask	1 of 59 (1.7%)	5 of 59 (8.5%)	1 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9189680Fitzpatrick RE. Laser resurfacing of rhytides. Dermatol Clin. 1997 Jul;15(3):431-47. doi: 10.1016/s0733-8635(05)70452-6.
Background: PubMed 16804006McCullough 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.
Background: PubMed 12877228Weiss 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.
BackgroundKim 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.
Background: PubMed 8629842Fitzpatrick 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.
Background: PubMed 1550366Griffiths 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stuart Lessin, M.D. principal investigator

KGL Skin Study Center, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Mask in people with Skin Aging, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores (time frame: Baseline to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03312543, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.