Skin Laxity, Wrinkle
Conditions
Keywords
laxity, facial lifting, wrinkles, rhytids
Brief summary
Single center, single-arm, prospective, open Label with Before & After Study Design.
Detailed description
Single center, single-arm, prospective, open Label with Before & After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.
Interventions
DEVICEtriLift system
To evaluate the efficacy of the triLift™ treatment
Sponsors
Lumenis Be Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is willing and able to read, understand, and sign the informed consent. * Healthy male or female aged 35 - 55 years. * Fitzpatrick skin type 1-6. * Subject is capable of reading, understanding, and following instructions of the procedure to be applied. * Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment.
Exclusion criteria
* Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago. * Concurrent participation in any other study. * Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past. * Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns). * Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis. * Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study. * Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study. * Subject has used topical retinoids in the past 1 month. * History of systemic cancer; premalignant skin lesion or skin concern treatment area. * Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders. * Poorly controlled endocrine disorders such as diabetes. * Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications. * History of collagen disorders, keloid formation or abnormal wound healing. * Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing. * Subject has used oral steroids in the past 6 months. * Subject has used topical steroids in the past 3 months. * History of bleeding coagulopathies or use of anticoagulants. * Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment. * Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.) * Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements. * Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Global Aesthetic Improvement scale (GAI) | 4 months | The Global Aesthetic Improvement scale (GAI) - Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, at the end of the treatment protocol as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3D images | 4 months | Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol |
| Comfort assessment | 3 months | Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), where 0 is no pain and 10 is worst pain possible |
| Subject level of Satisfaction | 4 months | Subject satisfaction will be assessed using a 5 level satisfaction questionnaire. |
Countries
United States
Contacts
Primary ContactFiona Kerr
Outcome results
None listed