- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01995604
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
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- 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
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 |
Intervention / Treatment |
---|---|
Experimental: dHACM
UltraPulse laser therapy with 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
|
Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.
|
What is the study measuring?
Primary Outcome Measures
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
Outcome Measure |
Time Frame |
---|---|
Erythema, edema, crusting, and exudate will be compared between both groups.
Time Frame: 30 Days
|
30 Days
|
Other Outcome Measures
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
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
September 1, 2013
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
November 21, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimate)
November 26, 2013
Study Record Updates
Last Update Posted (Estimate)
June 13, 2014
Last Update Submitted That Met QC Criteria
June 12, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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