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The purpose of this study is to evaluate the efficacy of dHACM (Dehydrated Human Amnion Chorion Membrane) for reducing time to healing when used in post-laser recovery following ActiveFXâ„¢ and DeepFxâ„¢ fractionated ablative CO2 laser resurfacing of the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dHACM | Experimental | UltraPulse laser therapy with application of dHACM |
|
| Sterile 0.9% Saline Solution | Placebo Comparator | UltraPulse laser therapy with application of Sterile 0.9% Saline Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of Sterile 0.9% Saline Solution | Other | Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema, edema, crusting, and exudate will be compared between both groups. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction | 30 Days |
Inclusion Criteria:
Male or female subjects in good general health greater than 18 years of age
Must be willing to agree to all terms of the protocol and provide a completed and signed informed consent, HIPAA and photography release forms
Subjects planning to undergo fractionated ablative CO2 laser resurfacing to the full face
Subject of either Fitzpatrick Skin Types I, II or III
Negative urine pregnancy test results at the time of study entry for females of childbearing potential, if applicable
Must be willing to comply with study instructions and complete the entire course of the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc. | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Application of dHACM | Other | Application of dHACM to half of face after UltraPulse laser therapy. |
|