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

Alma Lasers

Status

Not yet enrolling

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Treatments

Device: Alma Harmony

Study type

Interventional

Funder types

Industry

Identifiers

NCT06102343

ALM-HAR-CLS-23-01

Details and patient eligibility

About

The ClearSkin module, Er: Glass 1540nm, is largely used in the treatment of acne vulgaris and acne scars. The non-ablative ER:Glass 1540 nm laser deeply penetrates the skin, causing thermal damage to the sebaceous glands, destroying P. acnes bacteria and reducing sebum production, while leaving the epidermis intact. The integrated vacuum mechanism extracts accumulated sebaceous material from the pores, while contact cooling protects the skin, reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis. Based on this background, the investigators have considered a pilot study aimed at assessing the efficacy and safety of the ClearSkin Module in treating subjects with facial acne scars.

Enrollment

41 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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