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Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.
Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treatment | Experimental | Treatment of facial skin wrinkles using the Alma Harmony platform with the ClearLift high power Q-switched (QS) 1064nm Nd:YAG laser module |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alma Harmony | Device | The ClearLift is a class IIb medical device, High Power Q-switched (QS) 1064nm Nd:YAG laser module in the Harmony system. It has a targeted laser module for the non-invasive removal of various colored tattoos, as well as deep and superficial benign pigmented lesions, wrinkles, fine lines, and skin tightening. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | 70% of participants will demonstrate any improvement in the treated facial skin wrinkles after ClearLift treatment based on the rating of three blinded assessors that will compare the baseline 2D photographs with the 3-month follow-up visit photographs and will rate the degree of improvement using the 5-points Global Aesthetic Improvement Scale (GAIS)- in which 1 denotes "Wors";2 denotes "No change";3 denotes "Improved"; 4 denotes "Much improved"; and 5 denotes "Very much improved". | at the 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoint | Improvement in the treated facial skin wrinkles after ClearLift treatment based on the rating of the investigator that will compare the baseline 2D photographs with the 1-month follow-up visit photographs and will rate the degree of improvement using the 5-points Global Aesthetic Improvement Scale (GAIS)- in which 1 denotes "Wors";2 denotes "No change";3 denotes "Improved"; 4 denotes "Much improved"; and 5 denotes "Very much improved". |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & Tolerability | At the beginning of each visit starting the second treatment visit, the investigator will record the occurrence of adverse events (such as prolonged Erythema/ Edema, Burns, Hematoma / Ecchymosis, Scarring, and Hyperpigmentation.) and will rate their severity according to a 3 points scale in which 1= mild; 2= moderate, and 3=severe. | throughout the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shir Bekerman, BSC,MBA | Contact | 522906172 | +972 | shir.bekerman@almalasers.co.il |
| Natalie Dror, PHD | Contact | 528264282 | +972 | natalie.dror@almalasers.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Arminda Avdulaj, MD | Head of San Luca Medical Clinic, Tirana, Albania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Luca Medical Clinic | Tirana | Albania |
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| at the 1-month follow-up |
| Secondary endpoint | Improvement in skin texture of the treated facial skin wrinkles, as evaluated by the VISIA 3D camera, at the 1- and 3-month follow-up visits compared to baseline | at the 1 and 3-month follow-up |
| Secondary endpoint | Participant's satisfaction with treatment at the 1- and 3-month follow-up visits, as evaluated using a 5-point Likert scale, in which 1 denotes "Very dissatisfied";2 denotes "Dissatisfied";3 denotes "Satisfied"; 4 denotes "Very satisfied"; and 5 denotes "Extremely satisfied ". | at the 1 and 3-month follow-up |
| Safety & Tolerability | Pain level using a 11- points Numerical Pain Rating Scale (NPRS) in which 0= "No pain" and 10="Worst possible pain", as evaluated at each treatment visit at the end of each treatment session. | immediately after each treatment session (up to 1 month) |