2940nm Er:YAG Laser and 1927nm Thulium Laser in Improving Atrophic Acne Scars
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|ClinicalTrials.gov Identifier: NCT04813419|
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Atrophic Acne Scar||Device: 1927nm thulium laser Device: 2940nm Er:YAG laser||Not Applicable|
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. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||adult patients with similar atrophic acne scar on both sides of face|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||patients and outcomes assessor are blinded to laser therapy received at each side of face|
|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|
|Actual Study Start Date :||June 11, 2020|
|Estimated Primary Completion Date :||March 20, 2021|
|Estimated Study Completion Date :||April 2021|
Active Comparator: right face
The right side of face of subjects
Device: 2940nm Er:YAG laser
The right face of subjects were treated with fractional 2940nm Er:YAG laser(MCL 31 Asclepion Laser Technologies, Germany), N25 mode. Energy was adjusted from 12 to 27J according to the severity of scarring. All patients received 3 treatment sessions totally at an average interval of 4 to 6 weeks.
Experimental: left face
The left side of face of subjects
Device: 1927nm thulium laser
The right face of subjects were treated with fractional 2940nm Er:YAG laser(MCL 31 Asclepion Laser Technologies, Germany), N25 mode. Energy was adjusted from 12 to 27J according to the severity of scarring. The left face of subjects were treated with fractional 1927nm thulium laser(Lavieen, korea). Parameters were set as stamp mode, a spot size of 5*5mm, a pulse time of 1000us, an energy intensity of 3645mJ/cm2 and a repetition of 1-3 times. All patients received 3 treatment sessions totally at an average interval of 4 to 6 weeks.
- Goodman＆Baron quantitative global scarring grading system (GBS) [ Time Frame: GBS change from baseline(T0) at 1 hour before the third session(T1) and 3 months after the final treatment(T2) ]It is evaluated by a blinded dermatologist. It is a international criteria evaluating acne scar according to scar number and type. Tpye :(A) Milder scarring(1 point each): macular erythematous or pigmented and mildly atrophic dish-like;(B)Moderate scarring(2 points each) :moderately atrophic dish-like, punched out with shallow bases, small scarring(<5mm), shallow but broad atrophic areas;(C)Severe scarring(3 points each): punched out with deep but normal bases, small scarring(<5mm), punched out with deep abnormal bases, small scarring(<5mm), linear or troughed dermal scarring, deep, broad atrophic areas. Scar numbers:1-10(1 point each), 11-20(2 points each),>20(3 points each).
- self-rated acne scar improvement [ Time Frame: 3 months after the final treatment(T2) ]It is evaluated by subjects themselves. Self-rated acne scar improvement ranged from 0 to 4, 0 meant no improvement, 1 represented 1-25% improvement, 2 represented 26-50% improvement, 3 represented 51-75% improvement and 4 represented 76-100% improvement.
- self-rated satisfaction score [ Time Frame: 3 months after the final treatment(T2) ]It is evaluated by subjects themselves. Satisfaction score ranged from 0 to 10: 0 meant not satisfied and 10 meant very satisfied.
- Pain score [ Time Frame: immediately after each laser treatment ]It is evaluated by subjects themselves with Visual analogue scale(VAS) , on a scale from 0 to 10, 0 meant no pain while 10 meant extremely painful.
- adverse effects [ Time Frame: through study completion, an average of 0.5 year ]Adverse reactions such as pain, erythema and edema, hyperpigmentation and hypopigmentation were recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813419
|Contact: kune K Lu, postgraduate||19858125820 ext firstname.lastname@example.org|
|Hangzhou, Zhejiang, China, 0571|
|Contact: Suiqing S Cai, doctor 13957107910 email@example.com|
|Study Chair:||Suiqing S Cai, doctor||2nd Affiliated Hospital, School of Medicine, Zhejiang University, China|