Photoaging
Conditions
Keywords
skin, sun damage, photoaging of face, skin care, laser therapy
Brief summary
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.
Interventions
DEVICELaser Therapy
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.
OTHERBasic Skin Care Regimen
Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks
OTHERLytera
cosmeceutical serum applied to face daily for 12 weeks
Sponsors
Allergan Sales, LLC
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aesthetics | baseline to 12 weeks | Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved) |
| Change in Skin Tone | baseline to 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lytera Arm 4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical | 7 |
| Placebo Arm 4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Basic Skin Care Regimen Only and Laser Therapy: Not Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Placebo Arm | Total | Lytera Arm |
|---|---|---|---|
| Age, Continuous | 51.57 years | 49.5 years | 47.43 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 2 / 7 | 2 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Change in Aesthetics
Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Time frame: baseline to 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lytera Arm | Change in Aesthetics | 2 score on a scale |
| Placebo Arm | Change in Aesthetics | 1 score on a scale |
Primary
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.
Time frame: baseline to 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lytera Arm | Change in Skin Tone | -8.7 score on a scale |
| Placebo Arm | Change in Skin Tone | -3.90 score on a scale |