Laser TherapyNCT01403597
Evaluation of Non-ablative and Fractional Combination Treatment for Improvement in Skin's Appearance
A study testing Refirme ST Applicator and Matrix RF Applicator in people with Laser Therapy and Rejuvenation, run by Syneron Medical.
Trial summary
The study is designed to determine the safety, efficacy, patient comfort and patient satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved under 510k clearances. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser Therapy, Rejuvenation
- What is being tested?
- Refirme ST Applicator and Matrix RF Applicator
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2012
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have skin condition that requires ablation and resurfacing such as visible lines, pores, pigmentation, and elastosis that correlate to a score of 2 6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis
- Age: At least 21 years of age and not older than 65 years of age
- Sex male or female
- 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).
- Agrees to sign the Informed Consent
- Desire to improve their facial skin appearance
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- Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
- Willingness to follow the treatment and follow-up schedule and the post-treatment care
- Not planning to improve their skin appearance in a different procedure during the complete experimental period.
Who cannot join
- 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: excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), indurate acne, 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 epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
- 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.
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- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
- Having a permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- 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.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- 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 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.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
- Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
- 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 skin nourishing supplements within 2 months of treatment or during the study.
- 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
- 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 received treatment with a light-based, radiofrequency or other devices within 3 month prior to treatment or during the study.
- Having received a facial dermabrasion or chemical peel treatment within 3 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 3 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
- Participation in a study of another device or drug within one month prior to enrollment or during the study.
About this study
Official title: Clinical Evaluation of the Impact of Non-ablative and Fractional Ablative Combination Treatment: a Prospective, Open Label, Single Group With Before-after Study Design
The study is designed to determine the safety, efficacy, patient comfort and patient satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved under 510k clearances. The evaluations will include skin condition, physician/subject improvement assessment, and subject comfort and satisfaction score by questionnaires.
Read the detailed description
The Refirme ST and the Matrix RF applicators are both FDA approved devices indicated for improvement of skin appearance. The Matrix RF applicator has FDA clearance for ablation, resurfacing of the skin, and for wrinkles treatment, whereas the Refirme-ST applicator has FDA clearance for non-invasive wrinkles treatment. The combined treatment of Refirme ST and Matrix RF is intended to improve skin appearance both by enhancement of collagen production as the result of the Refirme ST primary heating of the treated area and by causing ablation and resurfacing of the skin with the Matrix RF. In the current clinical setting, each applicator is used in a separate session although there is no contra-indication preventing the usage of these applicators in the same treatment session. A combined treatment in one session is believed to be more efficient and will be more time effective for the patient and therefore will have a commercial benefit for the manufacturer.
- Conditions
- Laser Therapy, Rejuvenation
- Being tested
- Refirme ST Applicator and Matrix RF Applicator
- Keywords
- Skin wrinkling, Skin aging, Skin pigmentation
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refirme ST Applicator and Matrix RF ApplicatorDevice
5 treatments with combination of devices every 4 weeks to the facial (or sub facial regions).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The defined areas for treatment are the entire face or at least two facial sub areas (e.g., peri-orbital and peri oral) with the combination of two devices where a total of 5 treatments every 4 weeks will be administered Receives: Device: Refirme ST Applicator and Matrix RF Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment
The treatment will be considered safe if no cutaneous reactions (including excessive erythema and edema, blister formation, erosion, ulcer, scarring, infection, pruritis or allergic reactions) except of mild pigment can be detected at the site of treatment at the final follow up.
Measured: 11 months
Efficacy of Treatment
The treatment will be considered efficacious if a result greater than ≥3 moderate to significant on GAI scale) of overall skin improvement will be marked at the final follow up
Measured: 11 months
Secondary outcomes (2)
Patient Satisfaction
The treatment will be considered satisfactory by the patient if a result ≥ 3 in the patient satisfaction scale will marked at the final follow up.
Measured: 11 months
Patient Comfort
The treatment will be considered comfortable if a result ≥ 2 in the patient comfort assessment scale will marked at the end of at least 3/5 or 2/4 treatments.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser TherapyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT01403597
- Sponsor's protocol ID
- SCP-1
- Status last verified
- Nov 2014
- First submitted
- 20 Jul 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- 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
- Clinical Evaluation of the Impact of Non-ablative and Fractional Ablative Combination Treatment: a Prospective, Open Label, Single Group With Before-after Study Design
- ClinicalTrials.gov ID
- NCT01403597
- Acronym / sponsor ID
- SCP-1
- Conditions
- Laser Therapy, Rejuvenation
- Keywords
- Skin wrinkling, Skin aging, Skin pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Jul 2011 (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 study is designed to determine the safety, efficacy, patient comfort and patient satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved under 510k clearances. The evaluations will include skin condition, physician/subject improvement assessment, and subject comfort and satisfaction score by questionnaires.
Detailed description
The Refirme ST and the Matrix RF applicators are both FDA approved devices indicated for improvement of skin appearance. The Matrix RF applicator has FDA clearance for ablation, resurfacing of the skin, and for wrinkles treatment, whereas the Refirme-ST applicator has FDA clearance for non-invasive wrinkles treatment. The combined treatment of Refirme ST and Matrix RF is intended to improve skin appearance both by enhancement of collagen production as the result of the Refirme ST primary heating of the treated area and by causing ablation and resurfacing of the skin with the Matrix RF. In the current clinical setting, each applicator is used in a separate session although there is no contra-indication preventing the usage of these applicators in the same treatment session. A combined treatment in one session is believed to be more efficient and will be more time effective for the patient and therefore will have a commercial benefit for the manufacturer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Refirme ST Applicator and Matrix RF ApplicatorThe defined areas for treatment are the entire face or at least two facial sub areas (e.g., peri-orbital and peri oral) with the combination of two devices where a total of 5 treatments every 4 weeks will be administered |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have skin condition that requires ablation and resurfacing such as visible lines, pores, pigmentation, and elastosis that correlate to a score of 2 6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis
- Age: At least 21 years of age and not older than 65 years of age
- Sex male or female
- 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).
- Agrees to sign the Informed Consent
Key exclusion criteria (25 listed)
- 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: excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), indurate acne, 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 epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
- Vascular lesion, tattoo or permanent make-up in the treated area
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 |
|---|---|---|
| Refirme ST Applicator and Matrix RF Applicator5 treatments with combination of devices every 4 weeks to the facial (or sub facial regions). | Device | Treatment |
Primary outcome
Safety of treatment
Time frame: 11 months
The treatment will be considered safe if no cutaneous reactions (including excessive erythema and edema, blister formation, erosion, ulcer, scarring, infection, pruritis or allergic reactions) except of mild pigment can be detected at the site of treatment at the final follow up.
Efficacy of Treatment
Time frame: 11 months
The treatment will be considered efficacious if a result greater than ≥3 moderate to significant on GAI scale) of overall skin improvement will be marked at the final follow up
2 secondary outcomes
Patient Satisfaction
Time frame: 11 months
Patient Comfort
Time frame: 11 months
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.
Questions about this trial
What is this clinical trial studying?
A study testing Refirme ST Applicator and Matrix RF Applicator in people with Laser Therapy and Rejuvenation, run by Syneron Medical.
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 9 inclusion and 25 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.
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.
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?
Safety of treatment (time frame: 11 months). 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.