RecruitingAccepts healthy volunteers
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Cytrellis Biosystems, Inc. · NCT03793348
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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40–70 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 35
- US sites recruiting
- 1
- Study start
- November 12, 2018
- Record last updated
- January 4, 2019
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Being studied: MCD
Conditions: Wrinkle
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion 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.
Exclusion Criteria
- 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 devices)
- 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 efficacy 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
Recruiting US locations
Laser and Skin Surgery of New York
New York, NY 10016
Site contact: Jennifer Moreno · 212-686-7306 · research@laserskinsurgery.com
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