Clinical trial NCT00811161: An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Official title: An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrinkles or Damaged Skin Condition
Keywords: Remodeling
Airgent
Hyaluronic acid
Collagen formation
Lead sponsor: PerfAction Ltd.
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation.
timeFrame: 3-12 months
Secondary outcomes:
measure: recording of adverse events.
timeFrame: 1-3 month
measure: Evaluate subjects' satisfactory of the treatment
timeFrame: 1-12 month
Other outcomes:
Locations:
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Dean D. AD-EL D. AD-EL, MD
role: PRINCIPAL_INVESTIGATOR
References: