To assess the efficacy, safety, and patient satisfaction associated with the treatment of the face and neck with the 2,910nm mid-infrared UltraClear Laser System using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin. Additionally, this study will assess the additive value of a post-treatment skincare regimen consisting of a serum and cream containing red deer umbilical cord lining mesenchymal stem cell conditioned media for faster healing and more robust rejuvenation.
Subjects will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin of the face and neck. Subjects will be randomized to have one of two post-laser skincare regimens which will be applied to the face and neck following laser treatment. All subjects will receive three (3) laser treatments to the face and neck using the UltraClear 2,910nm mid-infrared laser, performed 5 weeks ± 7 days apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
* CeraVe gentle facial cleanser (CeraVe; New York, NY) to be used morning and evening * CeraVe lotion (CeraVe; New York, NY) to be used morning and evening, reapply as needed for dry skin * A mineral CeraVe sunscreen (CeraVe; New York, NY) to be applied in the morning and reapplied every 2 hours if going outside
* CeraVe gentle facial cleanser (CeraVe; New York, NY) to be used morning and evening * Calecim® Professional Serum (CellResearch Corporation; Singapore) to be used morning and evening * Calecim® Restorative Hydration Cream (CellResearch Corporation; Singapore) to be used morning and evening, reapply as needed for dry skin * A mineral CeraVe sunscreen (CeraVe; New York, NY) to be applied in the morning and reapplied every 2 hours if going outside
Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale to assess change (blinded investigator)
Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale - FACE TO BE COMPLETED BY BLINDED INVESTIGATOR Class: Wrinkling Score Degree of Elastosis I Fine Wrinkles 1 -3 Mild II Fine to Moderate 4 -6 Moderate III Fine to Deep 7 -9 Severe
Time frame: Baseline, Day 60, Day 250
Scientific Assessment Scale of Skin Quality to assess change (SASSQ) (blinded investigator)
SCIENTIFIC ASSESSMENT SCALE OF SKIN QUALITY (SASSQ) Elasticity: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Wrinkles: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Skin Surface Roughness: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Pigmentation: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Erythema: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe Pore Size: 0-None 1-Mild 2-Moderate 3-Severe 4-Very Severe
Time frame: Baseline, Day 160, Day 250
Classification of Facial Wrinkles Assessment to assess change (blinded investigator)
Classification of Facial Wrinkles Assessment: Preauricular Lines: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme Cheek Folds: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme Upper Lip Lines: 0-None 1-Very Mild 2-Mild 3-Moderate 4-Severe 5-Extreme
Time frame: Baseline, Day 160, Day 250
Neck Skin Crepiness/Laxity Grading Scale to assess change (blinded investigator)
Neck Skin Crepiness/Laxity Grading Scale: Score Classification Description 0 None No Loose Skin 1. Mild Mildly Loose Skin 2. Moderate Moderately Loose Skin 3. Severe Very Loose Skin 4. Extreme Prominent redundancy of loose skin
Time frame: Baseline, Day 160, Day 250
Visia Skin Analysis to assess change
Visia Skin Analysis (insert percentage 1 - 100%) Description: Percentage: Brown Spots Pores Spots Porphyrin Red Areas Texture UV Spots Wrinkles
Freia Canals Cistero, RN
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Time frame: Baseline, Day 160, Day 250
Physician Global Aesthetic Improvement Scale to assess change (PGAIS) (blinded investigator)
Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or circle "Not Treated") FACE NECK not treated not treated
Time frame: Day 160, Day 250
Percent Improvement Evaluation to assess change
Percent Improvement Evaluation: Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%)
Time frame: Day 160, Day 250
Evaluation of side effects and adverse events by Investigator to assess change
Evaluation of Side Effects and Adverse Events: Rating Description 0 NONE: Normal 1. TRACE: Barely visible and localized 2. MILD: Somewhat visible and diffuse 3. MODERATE: Visible and diffuse 4. SEVERE: Extremely visible and dense SCORES (write number under each treated area or check "Not Treated") Erythema: FACE NECK Edema: FACE NECK Hyperpigmentation: FACE NECK Blistering: FACE NECK Burn: FACE NECK Skin Crusting: FACE NECK
Time frame: Baseline, Day 35, Day 70, Day 160, Day 250
Comfort Level Visual Analog Scale post laser procedure to assess change (completed by subject)
Comfort Level Visual Analog Scale post laser procedure (circle one) Face: No Pain Moderate Pain Worst Pain 0 1 2 3 4 5 6 7 8 9 10 Neck: No Pain Moderate Pain Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time frame: Baseline, Day 35, Day 70
Subject Global Aesthetic Improvement Scale to assess change (SGAIS)
Subject Global Aesthetic Improvement Scale Assessment (SGAIS) Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or circle Not Treated) FACE NECK not treated not treated
Time frame: Day 160, Day 250
Subject Satisfaction Questionnaire to assess change
Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you. Rating Description 0 Not satisfied 1. Somewhat satisfied 2. Satisfied 3. Very satisfied 4. Extremely Satisfied Scores (write a number to rate each treated area) FACE NECK not treated not treated
Time frame: Day 160, Day 250