An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811161
Recruitment Status : Unknown
Verified June 2009 by PerfAction Ltd..
Recruitment status was:  Recruiting
First Posted : December 18, 2008
Last Update Posted : June 4, 2009
Information provided by:
PerfAction Ltd.

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.

Condition or disease Intervention/treatment Phase
Wrinkles or Damaged Skin Condition Device: Airgent Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Study Start Date : May 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: needle free injector of HA Device: Airgent
HA needle free injection, 3-4 treatments, 3-4 weeks apart

Primary Outcome Measures :
  1. Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation. [ Time Frame: 3-12 months ]

Secondary Outcome Measures :
  1. recording of adverse events. [ Time Frame: 1-3 month ]
  2. Evaluate subjects' satisfactory of the treatment [ Time Frame: 1-12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811161

Contact: Dean D. AD-EL, MD +972 3 937 6366

Rabin Medical Center Recruiting
Petah Tiqwa, Israel
Contact: Dean D. AD-EL, MD    +972 3 937 6366   
Principal Investigator: Dean AD-EL, MD         
Sub-Investigator: Oren Ganor, MD         
Sponsors and Collaborators
PerfAction Ltd.
Principal Investigator: Dean D. AD-EL D. AD-EL, MD Rabin Medical Center

Responsible Party: Dr. Dean D. AD-E/ Head, Department of Plastic Surgery & Burn Unit, Rabin Medical Center Identifier: NCT00811161     History of Changes
Other Study ID Numbers: AR12345
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by PerfAction Ltd.:
Hyaluronic acid
Collagen formation

Additional relevant MeSH terms:
Skin Diseases