NCT06102343

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Alma Lasers · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Alma Harmony	Acne scars treatment using non-ablative ER:Glass 1540 nm laser module.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-10-26
• Last updated: 2023-10-26

Locations

1 site across 1 country: Portugal