Back to resultsAn Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Primary Purpose
Wrinkles or Damaged Skin Condition
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Airgent
Sponsored by
About this trial
This is an interventional treatment trial for Wrinkles or Damaged Skin Condition focused on measuring Remodeling, Airgent, Hyaluronic acid, Collagen formation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
needle free injector of HA
Arm Description
Outcomes
Primary Outcome Measures
Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.
Secondary Outcome Measures
recording of adverse events.
Evaluate subjects' satisfactory of the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811161
Brief Title
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Official Title
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
PerfAction Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkles or Damaged Skin Condition
Keywords
Remodeling, Airgent, Hyaluronic acid, Collagen formation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
needle free injector of HA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Airgent
Intervention Description
HA needle free injection, 3-4 treatments, 3-4 weeks apart
Primary Outcome Measure Information:
Title
Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.
Time Frame
3-12 months
Secondary Outcome Measure Information:
Title
recording of adverse events.
Time Frame
1-3 month
Title
Evaluate subjects' satisfactory of the treatment
Time Frame
1-12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dean D. AD-EL, MD
Phone
+972 3 937 6366
Email
deana@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean D. AD-EL D. AD-EL, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tiqwa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean D. AD-EL, MD
Phone
+972 3 937 6366
Email
deana@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Dean AD-EL, MD
First Name & Middle Initial & Last Name & Degree
Oren Ganor, MD
12. IPD Sharing Statement
Learn more about this trial
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
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