Facial WrinklesNCT01566396
Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles
A study testing A3F in people with Facial Wrinkles, run by Pollogen at 2 sites in United States.
Trial summary
The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- A3F
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Oct 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject read, understood and signed the Consent Form
- Healthy female/male aged 35 65 years,
- Fitzpatrick wrinkle classification score 3 and above
- Fitzpatrick skin type 2-5
- Subject is capable of reading, understanding and following instructions of the procedure to be applied.
- Subject is able and willing to comply with the treatment and follow-up schedule.
Who cannot join
- Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
- Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
- Subject has current or history of cancer, especially skin cancer or premalignant moles or is undergoing any form of treatment for active cancer.
- Subject has severe concurrent conditions such as epilepsy, lupus or cardiac disorders.
- Subject has poorly controlled endocrine disorders such as diabetes.
- Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
Show all 24Show fewer
- Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
- Subject has a condition that could be negatively affected by heat, including any history of diseases stimulated by heat, such as recurrent Herpes Simplex (in the treatment area).
- Subject has diminished or exaggerated perception of temperature changes.
- Subject has significant concurrent skin conditions affecting areas to be treated such as sores, hemorrhages or risk of hemorrhages, septic conditions, psoriasis, eczema and rash as well as very dry and fragile skin.
- Subject has history of collagen disorders, keloid formation and abnormal wound healing.
- Subject has had previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans on such treatment during the course of the study, or before complete healing has occurred.
- Subject has had Botox injections in the treatment area within 6 months prior to initial treatment
- Subject has had natural fillers within 9 months prior to initial treatment
- Subject has synthetic fillers, injected chemical substance or gold/plastic threads in the treatment area.
- Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing such as prolonged steroid regime, tetracyclines, or St. John's Wort for the last 3 months.
- Subject has used oral isotretinoin (Accutane or Roaccutan) within 6 months prior to study enrollment or plans use during the course of the study.
- Subject has history of bleeding coagulopathies or use of anticoagulants.
- Use of non-steroidal anti inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment
- Tattoo or permanent makeup in the treated area
- Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
- Concurrent participation in any other study.
- Subject has mental disorders that in the opinion of the Investigator would be interfere with ability to comply with the study requirements.
- Subject is allergic to the topical anesthetic used in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Research Across America
Plano, Texas, 75093
About this study
The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.
Read the detailed description
The need for cosmetic facial enhancement procedures with minimal down time and low risk has led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers were developed, which remove the full skin surface in a controlled manner1,2. However, the prolonged recovery and the significant risks prompted the development of fractional lasers which ablate the skin in a fractional manner, leaving untreated areas to improve healing process3. In the past few years, fractional RF systems have been introduced that enable controlled skin resurfacing accompanied with dermal collagen remodeling4,5,6. The new 3F Applicator (A3F, trade name TriFractional) from Pollogen™ is designed to enable skin resurfacing and treatment of wrinkles using radiofrequency energy.
The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.
- Conditions
- Facial Wrinkles
- Being tested
- A3F
- Keywords
- Fractional,, RF,, Wrinkles, Safety, Efficacy, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A3FDevice
A3F fractional RF treatments for facial wrinkles
| Study group | Role | What they receive |
|---|---|---|
| A3F | Experimental | A3F, Fractional RF treatment Receives: Device: A3F |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the 3F Applicator (A3F) for treatment of facial wrinkles.
The safety of using the 3F Applicator (A3F) for treatment of facial wrinkles a will be established by physician's assessment/observation of adverse events. AEs will be tabulated by severity and relation to treatment.
Measured: 6 months
Secondary outcomes (1)
To evaluate the efficacy of the 3F Applicator (A3F) for treatment of facial wrinkles.
Efficacy of using the 3F Applicator (A3F) for treatment of facial wrinkles will be established by level of wrinkle reduction. The treated area will be photographed, using high-resolution macro photography prior to the treatments and at the follow up visits. The pre - and post-treatment photographs will be compared and scored by two independent uninvolved physicians.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pollogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mira Barki, PhD, Study director, Pollogen Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566396
- Sponsor's protocol ID
- PC210117_F, rev. 01
- Status last verified
- May 2012
- First submitted
- 27 Mar 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles
- ClinicalTrials.gov ID
- NCT01566396
- Acronym / sponsor ID
- PC210117_F, rev. 01
- Conditions
- Facial Wrinkles
- Keywords
- Fractional,, RF,, Wrinkles, Safety, Efficacy, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PollogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Mar 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.
The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.
Detailed description
The need for cosmetic facial enhancement procedures with minimal down time and low risk has led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers were developed, which remove the full skin surface in a controlled manner1,2. However, the prolonged recovery and the significant risks prompted the development of fractional lasers which ablate the skin in a fractional manner, leaving untreated areas to improve healing process3. In the past few years, fractional RF systems have been introduced that enable controlled skin resurfacing accompanied with dermal collagen remodeling4,5,6. The new 3F Applicator (A3F, trade name TriFractional) from Pollogen™ is designed to enable skin resurfacing and treatment of wrinkles using radiofrequency energy.
The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. This study was designed in order to evaluate the safety and efficacy of the A3F for treatment of facial wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A3F | Experimental | Device: A3FA3F, Fractional RF treatment |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject read, understood and signed the Consent Form
- Healthy female/male aged 35 65 years,
- Fitzpatrick wrinkle classification score 3 and above
- Fitzpatrick skin type 2-5
- Subject is capable of reading, understanding and following instructions of the procedure to be applied.
Key exclusion criteria (24 listed)
- Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
- Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
- Subject has current or history of cancer, especially skin cancer or premalignant moles or is undergoing any form of treatment for active cancer.
- Subject has severe concurrent conditions such as epilepsy, lupus or cardiac disorders.
- Subject has poorly controlled endocrine disorders such as diabetes.
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 |
|---|---|---|
| A3FA3F fractional RF treatments for facial wrinkles | Device | A3F |
Primary outcome
To evaluate the safety of the 3F Applicator (A3F) for treatment of facial wrinkles.
Time frame: 6 months
The safety of using the 3F Applicator (A3F) for treatment of facial wrinkles a will be established by physician's assessment/observation of adverse events. AEs will be tabulated by severity and relation to treatment.
1 secondary outcome
To evaluate the efficacy of the 3F Applicator (A3F) for treatment of facial wrinkles.
Time frame: 6 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 19 Oct 2012.
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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.
Mira Barki, PhD study director
Pollogen Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A3F in people with Facial Wrinkles, run by Pollogen at 2 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 6 inclusion and 24 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 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
To evaluate the safety of the 3F Applicator (A3F) for treatment of facial wrinkles. (time frame: 6 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 19 Oct 2012.