Aesthetic DermatologyPhase 2/3eMatrixCO2NCT00992277
In-vivo Analysis and Clinical Evaluation of the Performance of a Fractional CO2 Laser System (eMatrixCO2)
A Phase 2/3 study testing Ablation and skin resurfacing in people with Aesthetic Dermatology, run by Syneron Medical at 3 sites in United States.
Trial summary
This study will: Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Dermatology
- What is being tested?
- Ablation and skin resurfacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Apr 2010
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent agreement signed by the subject.
- Healthy males or females older than 21 years of age.
- Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I - V).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Who cannot join
- Pregnant and/or breastfeeding.
- Having a permanent implant in the facial skin area, such as an injected chemical substance - Not relevant for the abdominoplasty group.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
- Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study- Not relevant for the abdominoplasty group.
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- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study.
- Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study- Not relevant for the abdominoplasty group.
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Vascular lesion, tattoo or permanent make-up in the treated area.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three month prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Zel Skin & Laser Specialists
Saint Edina, Minnesota, 55424
Scripps Health
San Diego, California, 92130
South Dermatology Institute
Tustin, California, 92780
About this study
Official title: In-vivo Analysis and Clinical Evaluation of the Performance of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue
This study will:
Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment.
Determine the safety and efficacy of treatment with eMatrixCO2 for use in Aesthetic dermatological procedures requiring the ablation, vaporization, excision, incision, or coagulation of soft tissue.
- Conditions
- Aesthetic Dermatology
- Being tested
- Ablation and skin resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation and skin resurfacingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Facial | Experimental | Skin rejuvenation treatments Receives: Procedure: Ablation and skin resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points
Measured: over time following treatment.
Record number and type of any AE during the study
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetic DermatologyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992277
- Sponsor's protocol ID
- DC75061
- Acronym
- eMatrixCO2
- Status last verified
- Nov 2014
- First submitted
- 8 Oct 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Analysis and Clinical Evaluation of the Performance of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue
- ClinicalTrials.gov ID
- NCT00992277
- Acronym / sponsor ID
- eMatrixCO2 / DC75061
- Conditions
- Aesthetic Dermatology
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 9 Oct 2009 (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.
This study will:
Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment.
Determine the safety and efficacy of treatment with eMatrixCO2 for use in Aesthetic dermatological procedures requiring the ablation, vaporization, excision, incision, or coagulation of soft tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial | Experimental | Procedure: Ablation and skin resurfacingSkin rejuvenation treatments |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent agreement signed by the subject.
- Healthy males or females older than 21 years of age.
- Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I - V).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Key exclusion criteria (23 listed)
- Pregnant and/or breastfeeding.
- Having a permanent implant in the facial skin area, such as an injected chemical substance - Not relevant for the abdominoplasty group.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
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 |
|---|---|---|
| Ablation and skin resurfacing | Procedure or surgery | Facial |
Primary outcome
Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points
Time frame: over time following treatment.
Record number and type of any AE during the study
Time frame: study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ablation and skin resurfacing in people with Aesthetic Dermatology, run by Syneron Medical at 3 sites 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points (time frame: over time following treatment.). The study lists 2 primary outcomes in all. 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 2 Dec 2014.