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

NCT00811161 | Unknown

• 1 other identifier: AR12345
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkles or Damaged Skin Condition

Keywords

Remodeling; Airgent; Hyaluronic acid; Collagen formation

Outcome Measures

Primary Outcomes (1)

• Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.

  3-12 months

Secondary Outcomes (2)

• recording of adverse events.

  1-3 month

• Evaluate subjects' satisfactory of the treatment

  1-12 month

Study Arms (1)

needle free injector of HA

EXPERIMENTAL

Device: Airgent

Interventions

Airgent DEVICE

HA needle free injection, 3-4 treatments, 3-4 weeks apart

needle free injector of HA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PerfAction Ltd.: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Study Officials

• Dean D. AD-EL D. AD-EL, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean D. AD-EL, MD

CONTACT

+972 3 937 6366; deana@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 18, 2008
• Study Start: May 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

IL (1)