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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Acne scars treatment using non-ablative ER:Glass 1540 nm laser module.
Up Clinic
Lisbon, Portugal
Reduction of at least 6 points in Goodman Baron's score at 3-month follow-up visit compared to baseline.
comparison of acne scars' Goodman Baron's score at baseline with acne scars' Goodman Baron's score at 3-month follow-up visit compared to baseline.
Time frame: throughout the study, up to 1 year.
Improvement in the treated facial acne scars after ClearSkin according to the General Aesthetic Improvement Scale (GAIS), at the 3-month follow-up visit compared to baseline.
70% of participants will demonstrate any improvement in the treated facial acne scars after ClearSkinTM according to the General Aesthetic Improvement Scale (GAIS), at the 3-month follow-up visit compared to baseline, as evaluated by three blinded assessors. The evaluation will be performed by means of the examination of the photography of treated facial acne scars performed using 2D photographs.
Time frame: throughout the study, up to 1 year.
Improvement in the treated facial acne scars after ClearSkin according to the General Aesthetic Improvement Scale (GAIS), at the 1-month follow-up visit compared to baseline.
Improvement in aesthetic appearance of the treated facial acne scars, as assessed by the principal investigator according to the General Aesthetic Improvement Scale (GAIS) at the 1-month follow-up visit compared to baseline. The evaluation will be performed by means of the examination of the photography of all treated facial acne scars performed using 2D photographs.
Time frame: throughout the study, up to 1 year.
Improvement in skin texture of the treated facial acne scars.
Improvement in skin texture of the treated facial acne scars, as evaluated by the 3D pictures taken at the 1- and 3-month follow-up visits compared to baseline.
Time frame: throughout the study, up to 1 year.
Participant's satisfaction rates
Participant's satisfaction with treatment with the investigational devices using a 5-point Likert scale, at 1- and 3-month follow-up visits.
Time frame: throughout the study, up to 1 year.
Adverse Events frequency & intensity.
Adverse Events frequency \& intensity, occurring at any time during the trial or follow-up periods.
Time frame: throughout the study, up to 1 year.
Pain level rates
Pain level using NPRS, as evaluated at each treatment visit at the end of each treatment session.
Time frame: throughout the study, up to 1 year.
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