Pivotal Study to Evaluate the Safety and Efficacy of a Micro-coring Device Treating Moderate to S… (NCT03573271) | Clinical Trial Compass
CompletedNot Applicable
Pivotal Study to Evaluate the Safety and Efficacy of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
United States30 participantsStarted 2018-03-26
Plain-language summary
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Who can participate
Age range40 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pr…
What they're measuring
1
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment