Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER:Glass 1540nm Laser Module in the Treatment of Acne Scars.

Launched by ALMA LASERS · Oct 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for people with facial acne scars using a special type of laser called the ClearSkin module. This laser treatment is designed to improve the appearance of acne scars by targeting the deeper layers of the skin without damaging the surface. It works by reducing oil production and bacteria that can cause acne, while also helping to remove clogged material from pores. The goal of the study is to see how safe and effective this laser treatment is for individuals with mild to moderate acne scars.

To participate in this trial, you need to be between 18 and 50 years old and have mild to moderate acne scars. You should be in good health and agree to avoid tanning and other facial procedures during the study. If you have a history of certain skin issues, infections, or have had other treatments recently, you may not be eligible. Participants can expect to attend regular visits and will need to give consent to be part of the study, including allowing photos to be taken for research purposes. Overall, this trial aims to provide a potential new option for improving acne scars safely and effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men or women aged 18 to 50 years
• • Presence of mild to moderate facial acne scars (according to Goodman \& Baron's scale)
• • Subjects in reasonably good general health, according to the 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 cosmeceutical/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 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 judgment.
• • 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 a 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 the 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 collagen vascular diseases
• • Subjects with thrombocytopenia
• • Subjects with peripheral vascular disease
• • Subjects with Melasma
• • Pregnant or lactating subjects