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

Sponsored by:	PerfAction Ltd.
Information provided by:	PerfAction Ltd.
ClinicalTrials.gov Identifier:	NCT00811161

Purpose

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	Intervention
Wrinkles or Damaged Skin Condition	Device: Airgent

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions

U.S. FDA Resources

Further study details as provided by PerfAction Ltd.:

Primary Outcome Measures:

Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation. [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

recording of adverse events. [ Time Frame: 1-3 month ] [ Designated as safety issue: Yes ]
Evaluate subjects' satisfactory of the treatment [ Time Frame: 1-12 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
needle free injector of HA: Experimental	Device: Airgent HA needle free injection, 3-4 treatments, 3-4 weeks apart

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811161

Contacts

Contact: Dean D. AD-EL, MD

+972 3 937 6366

deana@clalit.org.il

Locations

Israel
Rabin Medical Center	Recruiting
Petah Tiqwa, Israel
Contact: Dean D. AD-EL, MD +972 3 937 6366 deana@clalit.org.il
Principal Investigator: Dean AD-EL, MD
Sub-Investigator: Oren Ganor, MD

Sponsors and Collaborators

PerfAction Ltd.

Investigators

Principal Investigator:

Dean D. AD-EL D. AD-EL, MD

Rabin Medical Center

More Information

No publications provided

Responsible Party:	Rabin Medical Center ( Dr. Dean D. AD-E/ Head, Department of Plastic Surgery & Burn Unit )
Study ID Numbers:	AR12345
Study First Received:	December 15, 2008
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00811161 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by PerfAction Ltd.:

Remodeling
Airgent
Hyaluronic acid
Collagen formation

Study placed in the following topic categories:

Skin Diseases
Hyaluronic Acid

Additional relevant MeSH terms:

Skin Diseases

ClinicalTrials.gov processed this record on September 03, 2009