ezGEL STUDY

Platelet-Rich Fibrin

The ezGEL system creates an autologous bio-stimulating Gel combining Platelet-Rich Fibrin (rich in platelets, leukocytes and mesenchymal stem cells), and self-assembled Albumin.

This is a prospective, single center, open label study to assess the safety and effectiveness of ezGEL for the correction of moderate to severe nasolabial folds. Following confirmed study eligibility, on screening visit (Day 0), the subject will be assessed by both the principal investigator and subject to rate the appearance of the nasolabial lines on a Wrinkle Severity Rating Scale (WSRS) scale. At the baseline visit, the subject will undergo treatment by the principal investigator. The screening and baseline visit can occur on the same day. After 3 days from the treatment visit, a phone call will be placed to assess for any safety events. At the day 14 visit, several assessments will be recorded. The day 28 visit will include an option for a touch-up treatment if deemed beneficial by both the treating investigator and the subject. If the subject receives a touch-up, another safety assessment call will be placed 3 days after the treatment. Subjects will follow-up in clinic for a week 8 and week 12 visit for photographs and subjective assessments. An optional retreatment may occur at the week 16 visit, with a safety assessment call placed 3 days subsequent to treatment. After a week 20 follow-up visit, the final visit will occur at week 24. Each study visit, safety assessment will occur, along with standardized photography, and evaluation of the nasolabial folds by both by the investigator and the subject.    

 

ezGEL STUDY

Rejuva Medical Aesthetics is recruiting participants for an exploratory study to evaluate the safety and efficacy of CosmoFrance ezGEL bio-filler to reduce the appearance of moderate to severe nasolabial folds.  

Purpose of the Study:

The objective of this exploratory study is to evaluate the safety and efficacy of CosmoFrance ezGEL bio-filler to reduce the appearance of moderate to severe nasolabial folds

Who may participate in this study?

You may qualify for this research study if the following applies to you:

  • You are male or non-pregnant, non-lactating female, 22 years of age or older.  

  • If you are female of childbearing potential, you are willing to agree to the use of a reliable method of contraception throughout the duration of the study.  

  • You have no plans to increase or decrease body weight by more than ten percent throughout the course of the study.4. You are willing to abstain from any aesthetic or surgical procedure in the treatment area for the duration of the study.  

  • You do not have any current, or history of, uncontrolled chronic or serious disease or medical condition that would put you at undue risk during treatment.

  • You are not an employee of the Investigator or research center or their immediate family members.  

  • You do not have an inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

  • You do not have a history or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.).  

  • You do not have an uncontrolled systemic disease, such as Epilepsy, Lupus, Diabetes, Sickle cell anemia, Multiple sclerosis, Fibromyalgia, Cancer, Chronic Fatigue Syndrome, Cystic Fibrosis, Heart Disease, Stroke, HIV, Asthma, Crohn’s Disease, or Muscular Dystrophy.

  • You do not have exposure to any other investigational drug/device within 30 days prior to study entry.  

  • You do not have a tendency to keloids, hypertrophic scars, and/or pigmentation disorders.  

  • You do not have a history of connective tissue diseases.  

  • You do not have facial plastic surgery, tissue augmentation with silicone, fat, or other non- absorbable substance in the nasolabial fold area.  

  • You do not have a history of bleeding disorders and/or use of anticoagulant, anti-platelet or thrombolytic medication from ten days pre- to three days post injection.

  • You do not have implantation of facial dermal fillers in the treatment area in the preceding twelve months.  

  • You have not had microneedling, botulinum toxin, dermabrasion, or mesotherapy in the lower 2/3rds of the face within the last 12 months.  

  • You do not have tattoos, piercings, facial hair, or scars that would interfere with the visualization of the nasolabial fold area for the effectiveness.  

  • You do not have abnormal vision assessments.

  • You must be logistically able to be present for all study visits and meet all study requirements.

  • You must agree to the publication and use of photos/videos documenting baseline, treatment progress and end of study outcomes.

There are other eligibility requirements. A final decision on whether this clinical trial is suitable for you will be made after you speak with the study doctor at the research site.

Your next steps

  • See if the study may be suitable for you by reviewing the criteria above

  • Submit your contact details to study personnel

  • Be contacted by a study coordinator for further information