Status:
COMPLETED
Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening
Lead Sponsor:
Endymion Medical Ltd
Conditions:
Skin Aging
Skin Wrinkling
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epid...
Eligibility Criteria
Inclusion
- Healthy males and females age 30 and up
- Subjects with Fitzpatrick 4 to 9 degrees of elastosis
- Subject able to comprehend and give informed consent for participation in this study
- Subject must commit to all treatments and follow-up visits
- Subject must sign the Informed Consent Form
Exclusion
- Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
- Subjects with any implantable metal device in the treatment area
- Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months
- Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area)
- Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study
- Subjects who have any form of suspicious lesion on the treatment area
- Subjects with history of keloid formations or hypertrophic scarring
- Pregnant or lactating Subjects
- Subjects with Epilepsy or severe migraines
- Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
- Subjects with any Infection / abscess / pains in treatment target area
- Eczema or dermatitis
- Subjects who suffer from autoimmune disorders or diabetes
- Subjects using blood thinning medications
- Subjects with clotting disorders
- Subjects on drugs or psychologically determined unsuitable for the study
- Subject is suffering extreme general weakness
- Subject objects to the study protocol
- Concurrent participation in any other clinical study
- Physician objection
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00945685
Start Date
July 1 2008
End Date
July 1 2009
Last Update
July 24 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Elman Clinique
Rishon LeZiyyon, Israel