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

Facial Skin Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349096
• Other study ID #: ALM-HAR-CLL-23-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Alma Lasers
• Contact: Shir Bekerman, BSC,MBA
• Phone: 522906172
• Email: shir.bekerman[@]almalasers.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Skin Wrinkles
• Facies

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Albania	San Luca Medical Clinic	Tirana

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers

Country where clinical trial is conducted

Albania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Primary	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	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".	at the 1-month follow-up
Secondary	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	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