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

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.

Study Overview

• Status: Unknown
• Conditions: Wrinkles or Damaged Skin Condition
• Intervention / Treatment: Device: Airgent

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: needle free injector of HA	Device: Airgent; HA needle free injection, 3-4 treatments, 3-4 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.	3-12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
recording of adverse events.	1-3 month
Evaluate subjects' satisfactory of the treatment	1-12 month

Collaborators and Investigators

• Sponsor: PerfAction Ltd.
• Investigators: Principal Investigator: Dean D. AD-EL D. AD-EL, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ANTICIPATED): February 1, 2010
• Study Completion (ANTICIPATED): April 1, 2010

Study Registration Dates

• First Submitted: December 15, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (ESTIMATE): December 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2009
• Last Update Submitted That Met QC Criteria: June 3, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Hyaluronic acid; Remodeling; Airgent; Collagen formation
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: AR12345