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

NCT06349096 | Not Yet Recruiting

• 1 other identifier: ALM-HAR-CLL-23-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Secondary endpoint

  at the 1-month follow-up

• Secondary endpoint

  at the 1 and 3-month follow-up

• Secondary endpoint

  at the 1 and 3-month follow-up

Other Outcomes (2)

• Safety & Tolerability

  throughout the study

• Safety & Tolerability

  immediately after each treatment session (up to 1 month)

Study Arms (1)

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

Device: Alma Harmony

Interventions

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.

Also known as: ClearLift applicator

Laser treatment

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alma Lasers: lead

Study Sites (1)

San Luca Medical Clinic

Tirana, Albania

Location

Study Officials

• Arminda Avdulaj, MD

  Head of San Luca Medical Clinic, Tirana, Albania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shir Bekerman, BSC,MBA

CONTACT

522906172; shir.bekerman@almalasers.co.il

Natalie Dror, PHD

CONTACT

528264282; natalie.dror@almalasers.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 5, 2024
• Study Start: March 26, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-03

Locations

AL (1)