Skin Texture IrregularitiesNCT01597323
Safety & Efficacy Evaluation of a Radiofrequency & Laser/Light System for Improvement of Skin Texture
An observational study of Skin Texture Irregularities and Facial Skin Wrinkles, run by Candela Corporation at 3 sites in United States.
Trial summary
Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light based device for the treatment of facial wrinkles. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Texture Irregularities, Facial Skin Wrinkles
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Oct 2011to 14 Oct 2014
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial photodamage (sun damage) and presence of mild to moderate facial wrinkling
Who may be able to join
- Healthy male or female between the ages of 35 and 60
- Non-smoker
- Fitzpatrick skin type I-VI
- Fitzpatrick Degree of Elastosis Score of 2-6 (inclusive)
- Presence of mild to moderate photodamage, such as solar lentigines, dyschromia and/or presence of mild to moderate facial wrinkling
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements
- Able to understand and provide written Informed Consent
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
Who cannot join
- Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit;
- 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
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
- Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study
- Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study
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- Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
- Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study
- Prior skin treatment with laser in treated area within 3 months of initial treatment or during the course of the study
- Prior use of Botox, collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 3-4 weeks of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants
- Prior ablative resurfacing procedure, brow lift, blepharoplasty or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study
- Any other surgery in treated area within 12 months of initial treatment or during the course of the study
- History of keloid formation or poor wound healing in a previously injured skin area
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity)
- Open laceration or abrasion of any sort on the area to be treated
- Active Herpes Simplex I at the time of treatment
- Multiple dysplastic nevi in the area to be treated
- Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to the treatment (as per the subject 's physician discretion)
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
- Having any form of active cancer at the time of enrollment and during the course of the study
- Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process
- Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- Tattoos, including cosmetic make-up tattoos, in the treatment area
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sanctuary Medical Aesthetic Center
Boca Raton, Florida, 33431
Cosmetic & Reconstructive Plastic Surgery
Great Neck, New York, 11021
The Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, 21030
About this study
Official title: Safety and Efficacy Evaluation of the eTWO System for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light based device for the treatment of facial wrinkles.
- Conditions
- Skin Texture Irregularities, Facial Skin Wrinkles
- Keywords
- Wrinkle Reduction, Skin Resurfacing, Skin Texture Improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial photodamage (sun damage) and presence of mild to moderate facial wrinkling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start25 Oct 2011
- Primary completion14 Oct 2014
- Study completion14 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Texture IrregularitiesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan H Gold, MD, Principal investigator, Board Certified Plastic Surgeon, American Board of Plastic SurgeonsRobert Weiss, MD, Principal investigator, Board Certified Dermatologist, American Board of Medical SpecialtiesJason N Pozner, MD, Principal investigator, Board Certified Plastic Surgeon, American Board of Plastic Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597323
- Sponsor's protocol ID
- DC84611
- Status last verified
- Dec 2019
- First submitted
- 10 May 2012
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the eTWO System for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
- ClinicalTrials.gov ID
- NCT01597323
- Acronym / sponsor ID
- DC84611
- Conditions
- Skin Texture Irregularities, Facial Skin Wrinkles
- Keywords
- Wrinkle Reduction, Skin Resurfacing, Skin Texture Improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2011 (actual)
- Primary completion
- 14 Oct 2014 (actual)
- Study completion
- 14 Oct 2014 (actual)
- First posted
- 14 May 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.
Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light based device for the treatment of facial wrinkles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | –Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial photodamage (sun damage) and presence of mild to moderate facial wrinkling |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial photodamage (sun damage) and presence of mild to moderate facial wrinkling
Key inclusion criteria (8 listed)
- Healthy male or female between the ages of 35 and 60
- Non-smoker
- Fitzpatrick skin type I-VI
- Fitzpatrick Degree of Elastosis Score of 2-6 (inclusive)
- Presence of mild to moderate photodamage, such as solar lentigines, dyschromia and/or presence of mild to moderate facial wrinkling
Key exclusion criteria (25 listed)
- Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit;
- 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
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
- Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course 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.
Primary outcome
Not reported in the source record.
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 6 Dec 2019.
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.
Alan H Gold, MD principal investigator
Board Certified Plastic Surgeon, American Board of Plastic Surgeons
Robert Weiss, MD principal investigator
Board Certified Dermatologist, American Board of Medical Specialties
Jason N Pozner, MD principal investigator
Board Certified Plastic Surgeon, American Board of Plastic Surgeons
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Texture Irregularities and Facial Skin Wrinkles, run by Candela Corporation 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 8 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 6 Dec 2019. 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.
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 6 Dec 2019.