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

NCT ID: NCT06102343

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-01

Brief Summary

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Study Design

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

Study Groups

acne scars treatment using the Alma Harmony platform with the ClearSkin applicator.

treatment of acne scars using the ClearSkin non-ablative ER:Glass 1540nm laser Module.

Group Type: EXPERIMENTAL

Alma Harmony

Intervention Type: DEVICE

Acne scars treatment using non-ablative ER:Glass 1540 nm laser module.

Interventions

Alma Harmony

Acne scars treatment using non-ablative ER:Glass 1540 nm laser module.

Intervention Type: DEVICE

Other Intervention Names

ClearSkin applicator

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alma Lasers

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiago Baptista, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Up Clinic, Lisbon, Portugal

Locations

Up Clinic

Lisbon, , Portugal

Countries

Portugal

Central Contacts

Natalie Dror, PhD

Role: CONTACT

natalie.dror@almalasers.co.il

+972528264282

Shir Beckerman, MA

Role: CONTACT

shir.beckerman@almalasers.co.il

+972522906172

Facility Contacts

Tiago Baptista, MD

Role: primary

tiagobf@hotmail.com

+351960041855

Other Identifiers

ALM-HAR-CLS-23-01

Identifier Type: -

Identifier Source: org_study_id