ScarringNCT01995604
Dehydrated Human Amnion/Chorion Membrane (dHACM) for Recovery After Fractionated Ablative CO2 Laser Resurfacing of the Face
A study testing Application of Sterile 0.9% Saline Solution and Application of dHACM in people with Scarring, run by MiMedx Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring
- What is being tested?
- Application of Sterile 0.9% Saline Solution and Application of dHACM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc.
San Diego, California, 92121
About this study
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
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.
- Conditions
- Scarring
- Being tested
- Application of Sterile 0.9% Saline Solution, Application of dHACM
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Sterile 0.9% Saline SolutionOther
Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.
Application of dHACMOther
Application of dHACM to half of face after UltraPulse laser therapy.
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | UltraPulse laser therapy with application of dHACM Receives: Other: Application of dHACM |
| Sterile 0.9% Saline Solution | Placebo comparator | UltraPulse laser therapy with application of Sterile 0.9% Saline Solution Receives: Other: Application of Sterile 0.9% Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization.
Measured: Day 30
Secondary outcomes (1)
Erythema, edema, crusting, and exudate will be compared between both groups.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchel P Goldman, MD, Principal investigator, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995604
- Sponsor's protocol ID
- EFLR001
- Status last verified
- Jun 2014
- First submitted
- 21 Nov 2013
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01995604
- Acronym / sponsor ID
- EFLR001
- Conditions
- Scarring
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Other: Application of dHACMUltraPulse laser therapy with application of dHACM |
| Sterile 0.9% Saline Solution | Placebo comparator | Other: Application of Sterile 0.9% Saline SolutionUltraPulse laser therapy with application of Sterile 0.9% Saline Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Negative urine pregnancy test results at the time of study entry for females of childbearing potential, if applicable
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Sterile 0.9% Saline SolutionApplication of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy. | Other | Sterile 0.9% Saline Solution |
| Application of dHACMApplication of dHACM to half of face after UltraPulse laser therapy. | Other | dHACM |
Primary outcome
The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization.
Time frame: Day 30
1 secondary outcome
Erythema, edema, crusting, and exudate will be compared between both groups.
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel P Goldman, MD principal investigator
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Sterile 0.9% Saline Solution and Application of dHACM in people with Scarring, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization. (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.