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

June 12, 2014 updated by: MiMedx Group, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization.
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Erythema, edema, crusting, and exudate will be compared between both groups.
Time Frame: 30 Days
30 Days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Pain Reduction
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MiMedx Group, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFLR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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