Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles

NCT ID: NCT06349096

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2024-10-31

Brief Summary

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

Conditions

Facial Skin Wrinkles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser treatment

Treatment of facial skin wrinkles using the Alma Harmony platform with the ClearLift high power Q-switched (QS) 1064nm Nd:YAG laser module

Group Type: EXPERIMENTAL

Alma Harmony

Intervention Type: 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.

Interventions

Alma Harmony

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.

Intervention Type: DEVICE

Other Intervention Names

ClearLift applicator

Eligibility Criteria

Inclusion Criteria

• Female subjects aged ≥ 35 and ≤ 55 years
• Presence of type 1-3 facial skin wrinkles, according to the Glogau scale;
• Subjects in reasonably good general health, according to Investigator's judgment;
• Subjects who agree to avoid tanning during the entire investigational period;
• Subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal or application of any cosmoceutical/pharmaceutical without the consent from the PI only.
• Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement.
• Subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs.

Exclusion Criteria

• Subjects with active infections;
• Subjects with history of keloid scarring or hypertrophic scar formation;
• Subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months;
• Subjects who have been tanning within the past 30 days;
• Previous surgical treatment of the area selected for the treatment with the investigational device;
• Subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site;
• Subjects with presence of tattoos at the treatment site;
• Subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.);
• Subjects with history of autoimmune disorder or evidence of immunosuppression;
• Subjects with cellulitis;
• Subjects with collagen vascular diseases;
• Subjects with thrombocytopenia;
• Subjects with peripheral vascular disease;
• Subjects with Melasma;
• Pregnant or lactating subjects.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alma Lasers

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arminda Avdulaj, MD

Role: PRINCIPAL_INVESTIGATOR

Head of San Luca Medical Clinic, Tirana, Albania

Locations

San Luca Medical Clinic

Tirana, , Albania

Countries

Albania

Central Contacts

Shir Bekerman, BSC,MBA

Role: CONTACT

shir.bekerman@almalasers.co.il

522906172 ext. +972

Natalie Dror, PHD

Role: CONTACT

natalie.dror@almalasers.co.il

528264282 ext. +972

Facility Contacts

Arminda Avdulaj, MD

Role: primary

avdulajarminda@gmail.com

694488000 ext. +355

Other Identifiers

ALM-HAR-CLL-23-01

Identifier Type: -

Identifier Source: org_study_id