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.
Males or females in good general health age 35-70 years of age.
Subjects with score Moderate to Severe (Class II-III, Score 4-9) on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale (Appendix E)
Subjects with score Moderate to Severe facial photodamage as assessed by the Modified Griffth's Scale (Appendix F)
Fitzpatrick skin types I-III.
Pregnant, planning to become pregnant during the course of the study, or breastfeeding.
Prescence of an active bacterial, fungal, or viral infection in the treatment area.
Significant history or current evidence of a medical, psychological or other condition that, in the investigator's opinion, would preclude enrollment into the study.
Use of any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
Parallel
Pavise Serum
DrugPavise ECMR (extracellular matrix restore) serum regimen combined with laser treatment
Sham Comparator
DrugVehicle serum regimen combined with laser treatment
Co2/Er:YAG
DeviceAblative 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
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
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
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
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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Goldman, Butterwick, Fitzpatrick and Groff
Lead sponsor
Bai Biosciences
Collaborator
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