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Tests treatment safety and results for Wrinkle
Official title Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
ClinicalTrials.gov ID: NCT03793348
What this study is testing
- What it's testing
- Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.
You likely can't join if
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory...
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone injections in the areas to be treated
- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study...
See the full eligibility criteria
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone injections in the areas to be treated
- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF...
- Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or currently being treated with immunosuppressive agents
- History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
- Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
- History or presence of any clinically significant bleeding disorder
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or how well it works or compromise the subject's ability to participate in the study
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Greenwood Village, Colorado, United States
- Miami, Florida, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Greenwood Village, Colorado, United States; Miami, Florida, United States; New York, New York, United States; Nashville, Tennessee, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.