Combination Versus Laser Treatment Only

Study Overview
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Brief Summary
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Our objective is to determine the effects of (1) basic skin care regimen + active (Lytera 2.0) vs. (2) basic skin care regimen only, both groups combined with laser, on the appearance of skin tone and photo-aging on the face.

Official Title
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Effect of Combination Laser Treatment and Skin Brightening Topical on the Appearance of Skin Tone and Photoaging: A Pilot Study

Conditions
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Photoaging

Intervention / Treatment
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* Device: Laser Therapy
* Other: Basic Skin Care Regimen
* Other: Lytera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male and female patients 18 years and older Fitzpatrick skin types I-IV Has at least mild mottled skin tone of the face (score of 2 or more on a 5 point skin tone scale) Has at least 2 areas of the face with significant roughness, dyspigmentation, or fine lines or has all these characteristics in 1 or more areas Willing to refrain from using any other topical products on the face, systemic retinoids, or steroids, facial peels or other facial laser procedures throughout the duration of the study Willing to refrain from any cosmetic procedure including but not limited to facial surgery, dermal fillers, and neuromodulators for the duration of the study Willing to use only the facial skin care product regimen provided for the study Willing to avoid extended periods of sun exposure and the use of tanning beds during the study Willing to have photographs taken of the face to be used de-identified in evaluations, publications, and presentations For females: proof that they are not pregnant (urine pregnancy test) English-speaker Exclusion Criteria: Has any uncontrolled systemic disease (such as autoimmune disorders and connective tissue disorders such as lupus erythematosus or Sjogren's syndrome Has any active infection in face Has history of any skin conditions that could interfere with treatment Has used self-tanner recently Is currently participating in another drug research study Is NOT willing to refrain from using any other topical products such as skin lightening, retinoids, alpha/beta-hydroxyl acids, salicylic acid, vitamins C or D, steroids, or antibiotics on the face or systemic retinoids, steroids, facial peels, neuromodulators, dermal fillers, facial surgery, or other facial laser procedures throughout the duration of the study For females: is pregnant Non English-speaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lytera Arm<br>4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments. | Device: Laser Therapy<br>* Clear and Brilliant Permea is a 1927nm fractional laser with 3 settings; low, medium, high. All interventions were done at low with four passes to each participant's full face.<br>* Other names: Clear and Brilliant Permea (1927nm fractional);Other: Basic Skin Care Regimen<br>* Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks<br>Other: Lytera<br>* cosmeceutical serum applied to face daily for 12 weeks<br>|
| Active Comparator: Laser only arm<br>4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments. | Device: Laser Therapy<br>* Clear and Brilliant Permea is a 1927nm fractional laser with 3 settings; low, medium, high. All interventions were done at low with four passes to each participant's full face.<br>* Other names: Clear and Brilliant Permea (1927nm fractional);Other: Basic Skin Care Regimen<br>* Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aesthetics | Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved) | baseline to 12 weeks | 
| Change in Skin Tone | Change in skin tone is assessed using the Modified Pigmentation Area and Severity Index (MoPASI). MoPASI assesses three facial region variables: 1) A = % area of involvement (0 = no involvement, 6 = 90% involvement), 2) D = darkness of pigment (0=absent, 4=maximum), 3) P = pattern of involvement (0=absent, 4=maximum). Four facial regions will be assessed: Forehead (0.2A), Left Cheek and periorbital (0.3A), Right Cheek and periorbital (0.3A), Nose/Lip/Chin (0.2A). The Total score ranges from 0-48 and is calculated using the formula: MoPASI = 0.2A(D + P) + 0.3A (D+P) + 0.3A (D+P) + 0.2A (D+P). A higher score indicates higher pigmentation. | baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin, sun damage, photoaging of face, skin care, laser therapy