Wrinkles or Damaged Skin ConditionNCT00811161
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
A study testing Airgent in people with Wrinkles or Damaged Skin Condition, run by PerfAction Ltd. at 1 site in Israel.
Trial summary
The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles or damaged skin with the Airgent device. The secondary objective of this study are to: Evaluate subjects' satisfactory of the treatment. Demonstrate the safety of the Airgent treatment by evaluation of adverse events. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles or Damaged Skin Condition
- What is being tested?
- Airgent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Apr 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males in good general health 18-65 years old
- Subject that are capable of reading, following directions, and understanding the procedure to be applied and that are obligated to forgo any other method of skin rejuvenation treatment for the entire study period.
Who cannot join
- Medical or psychiatric conditions that can affect the subject's ability to give informed consent, or complete the study.
- Pregnant or lactating females.
- Other known diseases including diabetes, autoimmune disorders, epilepsy, severe migraines chronic liver or kidney
- Disease or contagious diseases, such as HIV or hepatitis
- Participation in a clinical trial within the last 30 days.
- Subjects on any medication (chronic use) that would affect the characteristic of the skin (medical or hormonal), such as NSAID, blood thinning medications, immunosuppressive drugs, steroids, vitamin E supplements and Isotretinoins within one month prior to enrollment.
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- Subjects who have any form of suspicious lesion on the treatment area.
- Subjects with history of keloid formations or hypertrophic scarring.
- Subjects with permanent makeup/ tattoo (in the treated area).
- Subjects with any cutaneous inflammation on the treatment area such as herpes or acne.
- Subjects with known sensitivity to hyaluronic acid or to egg products.
- Subjects with clotting disorders.
- Subjects addicted to drug or alcohol.
- Subjects who underwent any aesthetic procedure in the treated area or adjacent to it.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Dean D. AD-EL, MD, +972 3 937 6366, deana@clalit.org.il
Dean AD-EL, MD
About this study
The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles or damaged skin with the Airgent device.
The secondary objective of this study are to:
- Evaluate subjects' satisfactory of the treatment.
- Demonstrate the safety of the Airgent treatment by evaluation of adverse events.
Read the detailed description
Each subject will attend the clinic for the screening visit, 3 or 4 treatment visits 3-4 weeks apart, and number of follow-up visits (three at least). Evaluation of results of the performed treatments will be performed in course of the next treatment visit (prior to performance the next treatment) and at follow-up visits at 1, 3 and 6 months after the last treatment in session. Additional evaluation visits at 9 and 12 months after completion the treatment session can be performed upon decision of the investigator in case when considerable improvement is recorded during the 6-months evaluation visit.
Biopsies from up to five subjects treated for stretch marks will be collected at the time of 3-months evaluation visit, from treated and untreated zone (one of each).
Subjects will be requested to refrain from using any other method of skin rejuvenation for the entire duration of the study.
- Conditions
- Wrinkles or Damaged Skin Condition
- Being tested
- Airgent
- Keywords
- Remodeling, Airgent, Hyaluronic acid, Collagen formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirgentDevice
HA needle free injection, 3-4 treatments, 3-4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| needle free injector of HA | Experimental | Not described Receives: Device: Airgent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.
Measured: 3-12 months
Secondary outcomes (2)
recording of adverse events.
Measured: 1-3 month
Evaluate subjects' satisfactory of the treatment
Measured: 1-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionFeb 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles or Damaged Skin ConditionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PerfAction Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dean D. AD-EL D. AD-EL, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811161
- Sponsor's protocol ID
- AR12345
- Status last verified
- Jun 2009
- First submitted
- 15 Dec 2008
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
- ClinicalTrials.gov ID
- NCT00811161
- Acronym / sponsor ID
- AR12345
- Conditions
- Wrinkles or Damaged Skin Condition
- Keywords
- Remodeling, Airgent, Hyaluronic acid, Collagen formation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PerfAction Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 18 Dec 2008 (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.
The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles or damaged skin with the Airgent device.
The secondary objective of this study are to:
- Evaluate subjects' satisfactory of the treatment.
- Demonstrate the safety of the Airgent treatment by evaluation of adverse events.
Detailed description
Each subject will attend the clinic for the screening visit, 3 or 4 treatment visits 3-4 weeks apart, and number of follow-up visits (three at least). Evaluation of results of the performed treatments will be performed in course of the next treatment visit (prior to performance the next treatment) and at follow-up visits at 1, 3 and 6 months after the last treatment in session. Additional evaluation visits at 9 and 12 months after completion the treatment session can be performed upon decision of the investigator in case when considerable improvement is recorded during the 6-months evaluation visit.
Biopsies from up to five subjects treated for stretch marks will be collected at the time of 3-months evaluation visit, from treated and untreated zone (one of each).
Subjects will be requested to refrain from using any other method of skin rejuvenation for the entire duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| needle free injector of HA | Experimental | Device: Airgent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females and males in good general health 18-65 years old
- Subject that are capable of reading, following directions, and understanding the procedure to be applied and that are obligated to forgo any other method of skin rejuvenation treatment for the entire study period.
Key exclusion criteria (14 listed)
- Medical or psychiatric conditions that can affect the subject's ability to give informed consent, or complete the study.
- Pregnant or lactating females.
- Other known diseases including diabetes, autoimmune disorders, epilepsy, severe migraines chronic liver or kidney
- Disease or contagious diseases, such as HIV or hepatitis
- Participation in a clinical trial within the last 30 days.
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 |
|---|---|---|
| AirgentHA needle free injection, 3-4 treatments, 3-4 weeks apart | Device | needle free injector of HA |
Primary outcome
Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.
Time frame: 3-12 months
2 secondary outcomes
recording of adverse events.
Time frame: 1-3 month
Evaluate subjects' satisfactory of the treatment
Time frame: 1-12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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.
Dean D. AD-EL D. AD-EL, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airgent in people with Wrinkles or Damaged Skin Condition, run by PerfAction Ltd. at 1 site in Israel.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean D. AD-EL, MD (+972 3 937 6366, deana@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation. (time frame: 3-12 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 4 Jun 2009.