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

This study is not yet open for participant recruitment.
Verified November 2013 by MiMedx Group, Inc.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01995604
First received: November 21, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 Intervention
Scarring
Other: Application of Sterile 0.9% Saline Solution
Other: Application of dHACM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erythema, edema, crusting, and exudate will be compared between both groups. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pain Reduction [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01995604

Locations
United States, California
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc. Not yet recruiting
San Diego, California, United States, 92121
Contact: William F Groff, D.O.    858-657-1002      
Principal Investigator: Mitchel P Goldman, MD         
Principal Investigator: William F Groff, DO         
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Mitchel P Goldman, MD Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01995604     History of Changes
Other Study ID Numbers: EFLR001
Study First Received: November 21, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Dehydration
Fibrosis
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014