The primary objective of this study is to evaluate the efficacy and tolerability of Pavise Extracellular Matrix Restore (ECMR), compared with standard acute post-operative care, when used as the primary occlusive treatment immediately following ablative CO₂ and Er:YAG facial laser resurfacing to support wound healing.
8 patients total will receive an ablative CO₂ and Er:YAG facial laser resurfacing treatment to the face. Each will be assigned to either Group A Control or Group B Active and given a skincare regimen to follow post procedure. Patients will return for follow up visits at Day 1 post procedure, Day 4 post procedure, Day 7 post procedure, 14 days post procedure and 3 months post procedure for 2D photography and assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
Pavise ECMR (extracellular matrix restore) serum regimen combined with laser treatment
Vehicle serum regimen combined with laser treatment
Ablative laser resurfacing treatment
Investigator Evaluation of Erythema, Edema, Exudation and Crusting
Circle one for Perioral Area: Erythema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Edema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Crusting: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Exudation: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Circle one for Periorbital Area: Erythema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Edema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Crusting: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Exudation: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe
Time frame: Day of procedure, post day 1, post day 4, post day 7, post day 14
Fitzpatrick Goldman Classification of Wrinkling and Degree of Elastosis Scale
Circle One: 1. Fine wrinkles with mild elastosis 2. Fine to moderate wrinkles with moderate elastosis 3. Fine to deep wrinkles with severe elastosis
Time frame: Screening, Baseline, 3 month visit
Tolerability Assessment by the Investigator
Circle One: Erythema 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Edema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Dryness: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe
Time frame: Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit
Subject Self Assessment Questionnaire
Rate from 0-10 for each of the following questions where 0 is no pain and 10 is excruciating pain 1. Pain 2. Itching 3. Tightness 4. Oozing 5. Crusting
Time frame: Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit
Subject Healing Questionnaire
Circle One 1. Study product supported my healing post procedure Strongly Agree Disagree Neutral Agree Strongly Agree 2. Study product reduces irritation Strongly Agree Disagree Neutral Agree Strongly Agree 3. Study product was not irritating or painful to apply Strongly Agree Disagree Neutral Agree Strongly Agree 4. I was satisfied with my recovery/progression Strongly Agree Disagree Neutral Agree Strongly Agree
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Time frame: post day 1, post day 4, post day 7, post day 14
Subject End of Study Self Assessment Questionnaire
Circle One: Please rate your improvement 0= Worse 1. No Improvement 2. Mild Improvement 3. Moderate Improvement 4. Pronounced Improvement
Time frame: 3 month visit
Investigator Global Improvement Assessment
Circle One: \] Please rate subjects improvement 0= Worse 1. No Improvement 2. Mild Improvement 3. Moderate Improvement 4. Pronounced Improvement
Time frame: 3 month visit