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

Withdrawn before enrolling · Not applicable

Conditions studied: Scarring

In brief

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.

Key facts

Study ID: NCT01995604
Run by: MiMedx Group, Inc.
People needed: 0
Starts: 2013-09-01
Expected to finish: 2013-12-01
Last updated by the study team: 2014-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc. — San Diego, California, United States

Full record on ClinicalTrials.gov

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