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| Name | Class |
|---|---|
| Bai Biosciences | UNKNOWN |
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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 COâ‚‚ and Er:YAG facial laser resurfacing to support wound healing.
8 patients total will receive an ablative COâ‚‚ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Sham Comparator | 4 participants will undergo an ablative COâ‚‚ and Er:YAG facial laser resurfacing treatment and receive Pavise ECMR (extracellular matrix restore) serum for post treatment care. |
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| Group B | Active Comparator | 4 participants will undergo an ablative COâ‚‚ and Er:YAG facial laser resurfacing treatment and receive vehicle serum for post treatment care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pavise Serum | Drug | Pavise ECMR (extracellular matrix restore) serum regimen combined with laser treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Investigator Evaluation of Erythema, Edema, Exudation and Crusting | Circle one for Perioral Area: Erythema: 0= None
Edema: 0= None
Crusting: 0= None
Exudation: 0= None
Circle one for Periorbital Area: Erythema: 0= None
Edema: 0= None
Crusting: 0= None
Exudation: 0= None
| Day of procedure, post day 1, post day 4, post day 7, post day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Fitzpatrick Goldman Classification of Wrinkling and Degree of Elastosis Scale | Circle One:
| Screening, Baseline, 3 month visit |
| Tolerability Assessment by the Investigator |
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Inclusion Criteria:
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.
Must be willing to give and sign Informed Consent Form, Photography Release Form and HIPAA Form.
The subject must be planning to undergo ablative CO2 and Er:YAG laser resurfacing to the face and willing to comply with study dosing and complete the entire course of the study.
Subjects using any skin care products (per physician-investigator discretion) must discontinue use of these products 14 days before treatment and throughout the duration of the study. Subjects will only use the products they are instructed to use by the investigator.
Male subjects with facial hair must be willing to shave the morning of the procedure
Female patients will be either of non-childbearing potential defined as: Having no uterus or no menses for at least 12 months. Women of childbearing potential must agree to use an effective method of birth control during the study, such as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| West Dermatology Research Center | Contact | 858-657-1004 | research@clderm.com | |
| Andrea Pacheco | Contact | apacheco@clderm.com |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D019066 | Facies |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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All subjects will receive on ablative laser facial treatment then be assigned to one of two groups for post treatment regimen.
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| Sham Comparator | Drug | Vehicle serum regimen combined with laser treatment |
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| Co2/Er:YAG | Device | Ablative laser resurfacing treatment |
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Circle One: Erythema 0= None
Edema: 0= None
Dryness: 0= None
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| 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
| Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit |
| Subject Healing Questionnaire | Circle One
| 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
| 3 month visit |
| Investigator Global Improvement Assessment | Circle One: ] Please rate subjects improvement 0= Worse
| 3 month visit |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |