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

• ClinicalTrials.gov Identifier: NCT01995604
• Recruitment Status: Withdrawn
• First Posted: November 26, 2013
• Last Update Posted: June 13, 2014
• Sponsor: MiMedx Group, Inc.
• Information provided by (Responsible Party): MiMedx Group, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Scarring	Other: Application of Sterile 0.9% Saline Solution; Other: Application of dHACM	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: September 2013
• Estimated Primary Completion Date: November 2013
• Estimated Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: dHACM; UltraPulse laser therapy with application of dHACM	Other: Application of dHACM; Application of dHACM to half of face after UltraPulse laser therapy.
Placebo Comparator: Sterile 0.9% Saline Solution; UltraPulse laser therapy with application of Sterile 0.9% Saline Solution	Other: Application of Sterile 0.9% Saline Solution; Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.

Outcome Measures

Primary Outcome Measures :

1. The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization. [ Time Frame: Day 30 ]

Secondary Outcome Measures :

1. Erythema, edema, crusting, and exudate will be compared between both groups. [ Time Frame: 30 Days ]

Other Outcome Measures:

1. Pain Reduction [ Time Frame: 30 Days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or female subjects in good general health greater than 18 years of age
2. Must be willing to agree to all terms of the protocol and provide a completed and signed informed consent, HIPAA and photography release forms
3. Subjects planning to undergo fractionated ablative CO2 laser resurfacing to the full face

4. 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.
5. Negative urine pregnancy test results at the time of study entry for females of childbearing potential, if applicable
6. Must be willing to comply with study instructions and complete the entire course of the study

Exclusion Criteria:

1. Any uncontrolled systemic disease that is not yet stabilized for at least one (1) year
2. 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
3. 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
4. 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)
5. Active bacterial, fungal, or viral infection
6. History of Herpes Simplex Virus to the facial and/or perioral areas
7. Known allergies or sensitivities to benzocaine, lidocaine, tetracaine, PABA (para-aminobenzoic acid), or other local anesthetics of the amide or ester family
8. Known allergies to gentamicin and/or streptomycin
9. 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
10. 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
11. Using any topical tretinoin product or derivative on their face within 12 weeks prior to or during the study period
12. 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
13. History of keloids or hypertrophic scars
14. Use of systemic retinoids, prescription or over-the-counter grade within the past year
15. A female subject who is pregnant, nursing an infant or planning a pregnancy during the study
16. 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

Contacts and Locations

Locations

United States, California

Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc.

San Diego, California, United States, 92121

Sponsors and Collaborators

MiMedx Group, Inc.

Investigators

• Principal Investigator: Mitchel P Goldman, MD; Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

More Information

• Responsible Party: MiMedx Group, Inc.
• ClinicalTrials.gov Identifier: NCT01995604
• Other Study ID Numbers: EFLR001
• First Posted: November 26, 2013
• Last Update Posted: June 13, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Dehydration; Cicatrix; Fibrosis; Pathologic Processes; Water-Electrolyte Imbalance; Metabolic Diseases