Skin Aging Clinical Trial
Official title:
Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening
Verified date | July 2009 |
Source | Endymion Medical Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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 (epidermis, dermis), wrinkles and elastosis - skin texture changes due to
collagen modification, skin laxity and cellulite (dermis and hypodermis).
EndyMion has developed the Imagine™ system - Computerized Radiofrequency System for Skin
Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern
can be produced allowing to selectively heating one or more of the target tissues
(epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis
would be targeted, creating enough thermal effect to induce collagen remodeling with no
ablative thermal damage in the epidermis or dermis. This post marketing study is intended
for evaluation of safety and efficacy of the Imagine™ system.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Elman Clinique | Rishon Le Zion |
Lead Sponsor | Collaborator |
---|---|
Endymion Medical Ltd |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety of using the Imagine™ System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn). | 3 months | Yes | |
Secondary | Efficacy endpoint of using the Imagine™ System for skin tightening will be established by level of skin tightness improvement. | 3 months | No |
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