Clinical trial NCT04813419: 2940nm Er:YAG Laser and 1927nm Thulium Laser in Improving Atrophic Acne Scars
Official title: Efficacy and Safety Comparison Between Fractional 2940nm Er:YAG Laser and Fractional 1927nm Thulium Laser in the Treatment of Facial Atrophic Acne Scars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophic Acne Scar
Keywords: 2940nm Er:YAG laser, 1927nm thulium laser
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: adult patients with similar atrophic acne scar on both sides of face
Primary purpose: TREATMENT

Brief summary: Fractional non-ablative laser (FNAL) has been widely used in improving acne scarring. However, there was only one study reported efficacy and safety of the fractional non-ablative 1927nm thulium laser (FTL) and no studies have reported a comparison between FTL and fractional ablative 2940nm Er:YAG laser(FEL), which had been proved effective and safety in many studies. Thus, we designed a prospective, simultaneous spilt-face trial to evaluate the efficacy and safety of FTL in the treatment of acne scarring and make a comparison between FTL and FEL, hoping to provide a new available modality for patients who are intolerable or reluctant to ablative lasers.

Detailed description: Acne vulgaris is a chronic and recalcitrant inflammation of pilosebaceous unit that has a high incidence rate in adolescence and even adults. Acne scarring is not an uncommon cosmetic complication which will cause physical and phycological pressure and impair the life quality of patients. It can be divided into two types according to morphology: atrophic and hypertrophic acne scarring. Atrophic acne scarring can be subclassified into boxcar, icepick and rolling scarring due to morphological features. Although a great variety of modalities to treat atrophic acne scarring such as chemical peeling, lasers and light, micro-needling and radiofrequency have emerged, fractional laser (FL) have come out on top. Unlike resurfacing lasers, FL creates three-dimensional, evenly distributed "microscopic thermal zones(MTZs)"on the treating area, which only covering about 3-40% of the skin and leaving the surrounding tissue undamaged and serving as "cell reservoir". Then, the MTZs can be rapidly replaced by keratinocytes in "cell reservoir" within the first 24 hours and by new collagen within 3-6 months. FL can be categoried into fractional ablative laser(FAL) and fractional non-ablative laser(FNAL).

With a wavelength of 2940nm, FEL could be highly absorbed by water-containing tissues of skin and cause superficial epidermis ablation and collagen induction\[4\]. But thermal damage is limited to about 20-50um. FTL has a moderate affinity for water content tissue. Thus, rather than causing epidermis turnover, it keeps the epidermis intact. But it can penetrate deep into 200-300um and stimulate collagen regeneration. Prior studies have shown that both FAL and FNAL were effective in treating acne scarring and the former were more effective while the latter had less side effects. However, in our clinic, we have observed outstanding effect and high satisfaction rate of FTL in improving atrophic acne scarring. Since there was only one clinical trial reported the efficacy and safety of FTL in Asian and no study have made a comparison between FTL and FEL, we designed this prospective, simultaneous spilt-face trial, hoping to provide a new available modality for patients who are intolerable or reluctant to ablative lasers.

Eligibility criteria: Inclusion Criteria:

age of at least 18 years clinical diagnose of facial atrophic acne scarring

Exclusion Criteria:

there was infection in the treatment site Acne vulgaris were not controlled had a propensity for keloid forming received oral isotretinoin or laser treatment in the past 3 months received chemical peeling 1 month before the study pregnancy or breast-feeding.

Primary outcomes:
measure: Goodman＆Baron quantitative global scarring grading system (GBS)
timeFrame: GBS change from baseline(T0) at 1 hour before the third session(T1) and 3 months after the final treatment(T2)
measure: self-rated acne scar improvement
timeFrame: 3 months after the final treatment(T2)
measure: self-rated satisfaction score
timeFrame: 3 months after the final treatment(T2)
Secondary outcomes:
measure: Pain score
timeFrame: immediately after each laser treatment
Other outcomes:
measure: adverse effects
timeFrame: through study completion, an average of 0.5 year
Locations:
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Suiqing S Cai, doctor
role: STUDY_CHAIR
References: