Status:
UNKNOWN
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Lead Sponsor:
PerfAction Ltd.
Conditions:
Wrinkles or Damaged Skin Condition
Eligibility:
All Genders
18-65 years
Phase:
NA
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 subjec...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00811161
Start Date
May 1 2009
End Date
April 1 2010
Last Update
June 4 2009
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel