Micro-coring device treatment for moderate to severe cheek wrinkles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Up to 35 adults with moderate to severe cheek wrinkles will receive a single treatment with the Cytrellis micro-coring device and be followed for 90 days. Effectiveness will be measured by physician-rated Lemperle and GAIS scales and by a subject satisfaction survey. Key eligibility includes ages 40–70, Fitzpatrick skin types I–IV, and a Lemperle wrinkle score of at least 3 on the cheeks, while patients with recent injections, scars, keloid history, active inflammatory lesions, or suspicious skin lesions are excluded. The sponsor is Cytrellis Biosystems, and the study is being conducted at three U.S. dermatology centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Laser and Skin Surgery of New York
  New York, New York, United States Recruiting
• Laser and Skin Surgery Center of Northern California
  Sacramento, California, United States Active not recruiting
• AboutSkin Research, LLC
  Greenwood Village, Colorado, United States Not yet recruiting
• Miami Dermatology & Laser Institute
  Miami, Florida, United States Active not recruiting
• The Office of Brian Biesman, M.D.
  Nashville, Tennessee, United States Active not recruiting
• Dallas Plastic Surgery Institute
  Dallas, Texas, United States Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.