Dehydrated Human Amnion/Chorion Membrane (dHACM) for Recovery After Fractionated Ablative CO2 Laser Resurfacing of the Face

Study Overview
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Brief Summary
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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 ActiveFX™ and DeepFx™ fractionated ablative CO2 laser resurfacing of the face.

Official Title
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A Single Center, Double Blinded, Placebo Controlled, Randomized, Split Face Study to Evaluate the Efficacy of dHACM (Dehydrated Human Amnion Chorion Membrane) for Recovery After Fractionated Ablative CO2 Laser Resurfacing of the Face

Conditions
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Scarring

Intervention / Treatment
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* Other: Application of Sterile 0.9% Saline Solution
* Other: Application of dHACM


Participation Criteria
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Eligibility Criteria
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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 For female subjects of childbearing potential, they must have had a regular menstrual cycle prior to study entry and is willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study. A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus and/or both ovaries, or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants Norplant, Depo-Provera, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of the partner. 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: Any uncontrolled systemic disease that is not yet stabilized for at least one (1) year A significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would interfere with the objectives of the study Recently excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days of study entry History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) Active bacterial, fungal, or viral infection History of Herpes Simplex Virus to the facial and/or perioral areas Known allergies or sensitivities to benzocaine, lidocaine, tetracaine, PABA (para-aminobenzoic acid), or other local anesthetics of the amide or ester family Known allergies to gentamicin and/or streptomycin Receiving any topical products containing alpha-hydroxy acids, salicylic acid, and Vitamins C or E (including derivatives of Vitamins C or E) on the face within 14 days prior to or during the study period, other than the ingredients of the study products Receiving and/or has had a microdermabrasion (light or medium skin peel) treatment on their face within 30 days prior to or during the study period Using any topical tretinoin product or derivative on their face within 12 weeks prior to or during the study period Receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a Dermabrasion (deep skin peel) or ablative laser treatments on their face must have discontinued the drug/treatment and/or had the procedure at least 3 months prior to entering the study History of keloids or hypertrophic scars Use of systemic retinoids, prescription or over-the-counter grade within the past year A female subject who is pregnant, nursing an infant or planning a pregnancy during the study Current participation or completed participation of a clinical research study for an investigational drug or device within 30 days prior to the start of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dHACM<br>UltraPulse laser therapy with application of dHACM | Other: Application of dHACM<br>* Application of dHACM to half of face after UltraPulse laser therapy.<br>|
| Placebo Comparator: Sterile 0.9% Saline Solution<br>UltraPulse laser therapy with application of Sterile 0.9% Saline Solution | Other: Application of Sterile 0.9% Saline Solution<br>* Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization. |  | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema, edema, crusting, and exudate will be compared between both groups. |  | 30 Days |