WrinklesNCT01645345
Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles
A study testing Alma Lasers Accent RF Pixel handpiece in people with Wrinkles and Acne Scars, run by Alma Lasers Inc. at 3 sites in United States.
Trial summary
To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles, Acne Scars
- What is being tested?
- Alma Lasers Accent RF Pixel handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2012to Mar 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects meeting the following inclusion criteria may participate:
- Male or female subject 18-60 years of age.
- Clinically documented rolling and boxcar acne scars and/or wrinkles score of 2 or 3 per the Rao-Goldman scale (see section 6.5.1 for wrinkle classification).
- Limitation to acne scared and wrinkles area: face.
- Patients must commit to all follow-up visits.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from participation:
- Bacterial or viral infection
- Impaired immune system
- Isotretinoin (Accutane, Amnesteem, Claravis, and Sotret) in the past 6 months
- Scleroderma
- Extensive radiation therapy
Show all 14Show fewer
- Burns in the treatment area
- Poor healing in the treatment area
- Metal implants near the treatment area
- Implantable pacemaker or automatic defibrillator/cardioverter (AICD)
- Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months in the areas to be treated
- Active cancer
- Active collagen or vascular disease
- Pregnancy or IVF procedure
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Victoria Cirillo-Hyland
Bryn Mawr, Pennsylvania, 19010
Metropolitan MD
Glenview, Illinois, 60025
Dr. Zimmerman
Las Vegas, Nevada, 89148
About this study
Official title: RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and
To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles.
Read the detailed description
The study design will be a prospective open label study. Up to 20 subjects of both genders with acne scars and/or wrinkles in the face will be recruited. The subjects will be treated once on clean acne scarred skin and three times on the the wrinkled skin with the Pixel RF handpiece. Each treatment duration will be approximately 30 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated (as well as the results of test sites).
Clinical improvement will be assessed by the investigator physician from the visual appearance of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Real-time assessments will be made as well by the investigators. Treatment and results will be documented in a Case Report Form and follow-up sessions (1, 5 days after the treatment and 1 month and 3 months after the treatment).
- Conditions
- Wrinkles, Acne Scars
- Being tested
- Alma Lasers Accent RF Pixel handpiece
- Keywords
- wrinkles, acne scars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alma Lasers Accent RF Pixel handpieceDevice
Treatment with fractionated RF Pixel device
| Study group | Role | What they receive |
|---|---|---|
| RF Pixel handpiece treatment | Other | There is only one arm, and that is a treatment arm. For patients with wrinkles and acne scars, they are being treated with the RF Pixel handpiece to decrease the appearance of these cosmetic deficiencies. The improvement is documented in before and after photographs. Receives: Device: Alma Lasers Accent RF Pixel handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the appearance of wrinkles and acne scars
Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645345
- Sponsor's protocol ID
- 022012
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2012
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and
- ClinicalTrials.gov ID
- NCT01645345
- Acronym / sponsor ID
- 022012
- Conditions
- Wrinkles, Acne Scars
- Keywords
- wrinkles, acne scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alma Lasers Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jul 2012 (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.
To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles.
Detailed description
The study design will be a prospective open label study. Up to 20 subjects of both genders with acne scars and/or wrinkles in the face will be recruited. The subjects will be treated once on clean acne scarred skin and three times on the the wrinkled skin with the Pixel RF handpiece. Each treatment duration will be approximately 30 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated (as well as the results of test sites).
Clinical improvement will be assessed by the investigator physician from the visual appearance of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Real-time assessments will be made as well by the investigators. Treatment and results will be documented in a Case Report Form and follow-up sessions (1, 5 days after the treatment and 1 month and 3 months after the treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF Pixel handpiece treatment | Other | Device: Alma Lasers Accent RF Pixel handpieceThere is only one arm, and that is a treatment arm. For patients with wrinkles and acne scars, they are being treated with the RF Pixel handpiece to decrease the appearance of these cosmetic deficiencies. The improvement is documented in before and after photographs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects meeting the following inclusion criteria may participate:
Key exclusion criteria (14 listed)
- Bacterial or viral infection
- Impaired immune system
- Isotretinoin (Accutane, Amnesteem, Claravis, and Sotret) in the past 6 months
- Scleroderma
- Extensive radiation therapy
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 |
|---|---|---|
| Alma Lasers Accent RF Pixel handpieceTreatment with fractionated RF Pixel device | Device | RF Pixel handpiece treatment |
Primary outcome
Improvement in the appearance of wrinkles and acne scars
Time frame: 3 months
Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.
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 24 Aug 2020.
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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 study testing Alma Lasers Accent RF Pixel handpiece in people with Wrinkles and Acne Scars, run by Alma Lasers Inc. 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 14 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 24 Aug 2020. 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.
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?
Improvement in the appearance of wrinkles and acne scars (time frame: 3 months). 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 24 Aug 2020.