Wrinkles or Damaged Skin Condition Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | April 2010 |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center | Petah Tiqwa |
| Lead Sponsor | Collaborator |
|---|---|
| PerfAction Ltd. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator/sub investigator assessment based on direct observation and photographs compared to baseline evaluation. | 3-12 months | No | |
| Secondary | recording of adverse events. | 1-3 month | Yes | |
| Secondary | Evaluate subjects' satisfactory of the treatment | 1-12 month | No |