Skin AgingNCT01029301
Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas
A study testing Device: EndyMed Pro System for Skin Tightening in people with Skin Aging and Skin Wrinkling, run by Endymion Medical Ltd.
Trial 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 (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Skin Wrinkling
- What is being tested?
- Device: EndyMed Pro System for Skin Tightening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
Official title: Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System
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).
EndyMed has developed the EndyMed Pro 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 EndyMed Pro system.
- Conditions
- Skin Aging, Skin Wrinkling
- Being tested
- Device: EndyMed Pro System for Skin Tightening
- Keywords
- Skin aging, Skin Wrinkling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: EndyMed Pro System for Skin TighteningDevice
Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed):
Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening);
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Endymed study group | Experimental | Not described Receives: Device: Device: EndyMed Pro System for Skin Tightening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of using the EndyMed Pro System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn).
Measured: 3 months
Secondary outcomes (1)
Efficacy endpoint of using the EndyMed Pro System for skin tightening will be established by level of skin tightness improvement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endymion Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Varda Godfried, Dr., Study director, EndyMed Medical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029301
- Sponsor's protocol ID
- ED-IOP- 01
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System
- ClinicalTrials.gov ID
- NCT01029301
- Acronym / sponsor ID
- ED-IOP- 01
- Conditions
- Skin Aging, Skin Wrinkling
- Keywords
- Skin aging, Skin Wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Endymion Medical LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
EndyMed has developed the EndyMed Pro 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 EndyMed Pro system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Endymed study group | Experimental | Device: Device: EndyMed Pro System for Skin Tightening |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: EndyMed Pro System for Skin TighteningBased on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed): Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening); | Device | Experimental: Endymed study group |
Primary outcome
The safety of using the EndyMed Pro System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn).
Time frame: 3 months
1 secondary outcome
Efficacy endpoint of using the EndyMed Pro System for skin tightening will be established by level of skin tightness improvement.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varda Godfried, Dr. study director
EndyMed Medical Ltd
Questions about this trial
What is this clinical trial studying?
A study testing Device: EndyMed Pro System for Skin Tightening in people with Skin Aging and Skin Wrinkling, run by Endymion Medical Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of using the EndyMed Pro System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.