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| Name | Class |
|---|---|
| Allergan Sales, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lytera Arm | Experimental | 4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments. |
|
| Laser only arm | Active Comparator | 4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Therapy | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Grunebaum, MD | Univeristy of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Aesthetics | Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved) | Posted | Median | Inter-Quartile Range | score on a scale | baseline to 12 weeks |
|
12 weeks
treatment emergent
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa D Grunebaum MD | University of Miami | 3052433223 | lgrunebaum@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2019 | Mar 10, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
| Basic Skin Care Regimen | Other | Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks |
|
| Lytera | Other | cosmeceutical serum applied to face daily for 12 weeks |
|
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | baseline to 12 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | 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 | 0 | 7 | 0 | 7 | 2 | 7 |
| dryness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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