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

NCT03312543 | Completed Results FDA Device

• 1 other identifier: CO-170511132943-SACT
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging

Keywords

Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (31)

• Global Wrinkling - Change From Baseline to Week 1

  Baseline to Week 1

• Global Wrinkling - Change From Baseline to Week 4

  Baseline to Week 4

• Global Wrinkling - Change From Baseline to Week 24

  Baseline to Week 24

• Fine Lines - Change From Baseline to Week 1

  1 week

• Fine Lines - Change From Baseline to Week 4

  Baseline to Week 4

Study Arms (2)

Active Cell: Active Mask

EXPERIMENTAL

Cleanser, Moisturizer, Active Mask

Device: Active Mask

Sham Cell: Sham Mask

SHAM COMPARATOR

Cleanser, Moisturizer, Sham Mask

Device: Sham Mask

Interventions

Active Mask DEVICE

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.

Also known as: Active Light Therapy Mask

Active Cell: Active Mask

Sham Mask DEVICE

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.

Also known as: Sham Light Therapy Mask

Sham Cell: Sham Mask

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

KGL Skin Study Center, LLC

Broomall, Pennsylvania, 19008, United States

Location

Related Publications (6)

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

  PMID: 9189680 BACKGROUND

• 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.

  PMID: 16804006 BACKGROUND

• 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.

  PMID: 12877228 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 8629842 BACKGROUND

• 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.

  PMID: 1550366 BACKGROUND

Results Point of Contact

• Title: Sidney Hornby
• Organization: Johnson & Johnson Consumer Inc.

SHornby@its.jnj.com

908-874-2756

Study Officials

• Stuart Lessin, M.D.

  KGL Skin Study Center, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 17, 2017
• Study Start: October 9, 2017
• Primary Completion: January 12, 2018
• Study Completion: April 6, 2018
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)