Skin ResurfacingNCT04153071
Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study
A study testing OPUS system in people with Skin Resurfacing, run by Alma Lasers at 1 site in United States.
Trial summary
Prospective, Open-Label, Single-Center Pilot Study. The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin. The study will include up to 2 subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Resurfacing
- What is being tested?
- OPUS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2019to 16 Sep 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject seeking surgical correction of abdominal tissue laxity with an abdominoplasty within the subsequent 1-12 months.
- Subject abdominal skin must be of appropriate quality to allow for proper study treatment, as judged by the Investigator.
- The subject must be willing to have punch biopsy specimens obtained from all treated areas following treatment.
- The Subject must sign a statement of informed consent to the Investigator and Sponsor.
Who cannot join
- The subject is less than 18 or greater than 75 years of age.
- Subject with excessive superficial skin laxity and/or striae of the abdomen, which would prevent proper study treatment.
- A subject that is unwilling to have punch biopsy specimens obtained from treated areas.
- Subject with a history of allergy to lidocaine or epinephrine.
- Known history of keloids or bleeding/coagulation disorder.
- Presence of surgical or non-surgical scars in the area to be treated.
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- Active inflammatory or infectious process or any other active or serious skin disease in the area to be treated.
- Planned surgical procedures with incisions and suturing in the area to be treated during the course of the study.
- Subjects who have had (or plan to have during the course of the study) an abdominal skin treatment with any exclusionary treatments, medications, and/ or devices.
- Subjects who have used oral isotretinoin or other oral retinoids during the study in the prior 12 months or planning to be on them during the course of the study.
- Subjects receiving antiplatelet, anticoagulant, or non-steroidal anti-inflammatory agents within 2 weeks of treatment, or planning to receive during the course of the study; in whom, in the Investigator's opinion, administration of radiofrequency treatment may cause procedure-related complications.
- Women who are pregnant, nursing or intend to become pregnant over the duration of the study, or women who are of childbearing potential not protected by an effective contraceptive method of birth control. Pregnancy status should be checked by urine testing at baseline (Day 0).
- Subjects who are unwilling or unable to give written consent to participate in the study or unable to comply with the requirements of the clinical trial protocol.
- Subjects who have received an experimental drug or device within the previous 3 months prior to enrollment.
- Subjects who are known as alcohol or drug abusers.
- Subjects who are suffering from any physical or psychological condition, or are under treatment for any such condition which, in the opinion of the Investigator, may constitute an unwarranted risk or which may affect the subjects' compliance or adherence to study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
About this study
Official title: Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study
Prospective, Open-Label, Single-Center Pilot Study.
The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin.
The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
- Conditions
- Skin Resurfacing
- Being tested
- OPUS system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPUS systemDevice
Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Unipolar microplasma RF treatment | Experimental | Single cutaneous unipolar microplasma RF treatment, with variable treatment parameters Receives: Device: OPUS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters
Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens
Measured: Immediately post treatment
Secondary outcomes (1)
Rate of adverse events
Safety will be monitored by documentation of adverse events
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start23 Oct 2019
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Why it stopped: Per Investigator and sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ResurfacingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Friedmann, MD, FAAD, Principal investigator, Westlake Dermatology Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153071
- Sponsor's protocol ID
- ALM-OPUS-19-010
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study
- ClinicalTrials.gov ID
- NCT04153071
- Acronym / sponsor ID
- ALM-OPUS-19-010
- Conditions
- Skin Resurfacing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per Investigator and sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alma LasersIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- 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.
Prospective, Open-Label, Single-Center Pilot Study.
The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin.
The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unipolar microplasma RF treatment | Experimental | Device: OPUS systemSingle cutaneous unipolar microplasma RF treatment, with variable treatment parameters |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject seeking surgical correction of abdominal tissue laxity with an abdominoplasty within the subsequent 1-12 months.
- Subject abdominal skin must be of appropriate quality to allow for proper study treatment, as judged by the Investigator.
- The subject must be willing to have punch biopsy specimens obtained from all treated areas following treatment.
- The Subject must sign a statement of informed consent to the Investigator and Sponsor.
Key exclusion criteria (16 listed)
- The subject is less than 18 or greater than 75 years of age.
- Subject with excessive superficial skin laxity and/or striae of the abdomen, which would prevent proper study treatment.
- A subject that is unwilling to have punch biopsy specimens obtained from treated areas.
- Subject with a history of allergy to lidocaine or epinephrine.
- Known history of keloids or bleeding/coagulation disorder.
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 |
|---|---|---|
| OPUS systemEach subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations. | Device | Unipolar microplasma RF treatment |
Primary outcome
Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters
Time frame: Immediately post treatment
Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens
1 secondary outcome
Rate of adverse events
Time frame: 10 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 25 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Daniel Friedmann, MD, FAAD principal investigator
Westlake Dermatology Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPUS system in people with Skin Resurfacing, run by Alma Lasers 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 4 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 25 Sep 2020. 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. 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?
Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters (time frame: Immediately post treatment). 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 25 Sep 2020.