Efficacy and Safety of Extracellular Matrix on Wound Healing After Picosecond Laser Therapy.

BACKGROUND: Extracellular matrix (ECM), a material with tissue repair function, is applied to treat various wounds. However, the role of ECM in facilitating wound healing after facial laser treatment remains elusive. OBJECTIVE: To assess the efficacy and safety of ECM in promoting wound healing after picosecond laser therapy (PLT). MATERIALS AND METHODS: Eighteen female subjects with benign pigmentation disorders were randomly assigned to the ECM (n = 9) and control groups (n = 9). After PLT, the ECM and control groups were treated with ECM and facial moisturizer in the first 7 days, respectively. The severity of erythema and edema was assessed using photographs. The duration of erythema, edema, scab shedding, postinflammatory hyperpigmentation incidence (PIH), and adverse events was documented in detail. RESULTS: Compared with the control group, the ECM group had a shorter duration of erythema, edema, and scab shedding after PLT (p < .01). A significantly decreased severity of erythema (p < .05) and edema (p < .01) was found in the ECM group versus the control group, respectively. The PIH incidence in the ECM group was lower than in controls, albeit without statistical significance. No serious adverse events were observed during the follow-up. CONCLUSION: Extracellular matrix is an effective and safe dressing for promoting wound healing after PLT.

Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial.

Nasolabial folds (NLFs) are the most pronounced sign of facial aging. This study explored the efficacy and safety of polycaprolactone gel in treating Chinese patients with moderate-to-severe NLFs. Patients with moderate-to-severe NLF who wished to be treated by dermal fillers were recruited from three centers between July 2017 and September 2019. The randomizing ratio was 1:1 in the polycaprolactone group (polycaprolactone injection) or control group (sodium hyaluronate gel injection). The primary endpoint was the effectiveness rate of Wrinkle Severity Rating Score (WSRS) scores at 12 months after injection. The full-analysis set (FAS) and safety sets had 80 patients in the polycaprolactone group and control group, respectively. In the FAS, the effectiveness rate at 12 months in the polycaprolactone group was 88.8% compared with 23.8% in controls (P < 0.001). The improvement in WSRS sustained during 12 months in the polycaprolactone group, while gradually vanished in the control group since 3 months after surgery. The global aesthetic improvement scale (GAIS) by investigator assessments was improved, much improved, or very much improved in all patients during follow-up, while the proportion of patients with a "no change" assessment gradually increased during follow-up after 6 months in the control group. The rates of injection-related adverse event (AE) and serve injection-related AE were 8.8 versus 11.3% and 0 versus 1.3% in the polycaprolactone group and control groups, respectively. Polycaprolactone gel injection is effective and safe to treat moderate-to-severe NLFs in Chinese patients.

Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Glabellar Lines in Chinese Patients: A Pivotal, Phase 3, Randomized, Double-Blind and Open-Label Phase Study.

BACKGROUND: Various botulinumtoxinA formulations are approved for glabellar lines treatment worldwide, including abobotulinumtoxinA (Dysport®). OBJECTIVES: Assess abobotulinumtoxinA superiority versus placebo and non-inferiority versus active comparator (onabotulinumtoxinA; Botox®), for the treatment of Chinese patients with moderate/severe glabellar lines. METHODS: Phase 3, randomized study (NCT02450526) comprising a double-blind (cycle 1) phase and an open-label (cycles 2-5) phase. Patients received abobotulinumtoxinA 50 units or matching placebo (5:1), active comparator (onabotulinumtoxinA 20 units) or matching placebo (5:1). In cycles 2-5, eligible patients were retreated with abobotulinumtoxinA only. Responders had glabellar lines of none/mild severity. PRIMARY ENDPOINT: responder rates at cycle 1, day 29 at maximum frown with abobotulinumtoxinA versus placebo (for superiority; by investigator's live assessment [ILA] and subject's self-assessment [SSA]), and versus active comparator (for non-inferiority; by ILA). Treatment-emergent adverse events were recorded. RESULTS: Overall, 520 patients were randomized. Superiority and non-inferiority, respectively, were demonstrated for abobotulinumtoxinA versus placebo (ILA, SSA; both p < 0.0001) and abobotulinumtoxinA versus active comparator. AbobotulinumtoxinA efficacy was maintained over open-label cycles; median time to onset of efficacy was 2.0 days. After 6 months, 17% of patients treated with abobotulinumtoxinA remained responders. AbobotulinumtoxinA was well-tolerated. Safety results were in line with the known profile of abobotulinumtoxinA; adverse events rate decreased with repeated treatment. CONCLUSIONS: After a single injection, abobotulinumtoxinA demonstrated superiority versus placebo and non-inferiority versus onabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines in Chinese patients. Multiple injections of abobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar lines in Chinese patients. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Botulinum toxin injections can be used to smooth frown lines that appear between the eyebrows (known as glabellar lines) in patients who have moderate or severe frown lines. This study looked at how injections of a botulinum toxin (abobotulinumtoxinA [aboBoNT-A]) could help with smoothing frown lines in patients from China compared with an injection of another botulinum toxin called onabotulinumtoxinA (onaBoNT-A) or placebo (saltwater, no treatment). The study included 520 patients from China, 18­65 years old, who had moderate or severe frown lines. All patients received a first injection of either aboBoNT-A, onaBoNT-A, or saltwater, and were studied for 12 weeks. After the first injection, patients could receive up to four more injections of aboBoNT-A, given at 12-week intervals, if their frown lines became moderate or severe again. Most patients (92%) had not previously received any botulinum toxin injections. The results showed that single and repeat injections of aboBoNT-A helped to smooth moderate and severe frown lines. The researchers found that after a single injection, aboBoNT-A was superior to no treatment and was similar to onaBoNT-A. Patients recorded a response to aboBoNT-A after 2 days and the response lasted for 6 months in 17% of patients. The effect on frown lines was maintained after repeat injections and aboBoNT-A was well tolerated by patients. These results suggest that aboBoNT-A is a suitable treatment for smoothing frown lines in patients from China with moderate to severe frown lines.

The efficacy of botulinum toxin A in the treatment of Raynaud's phenomenon in systemic sclerosis: A randomized self-controlled trial.

The current conservative and surgical treatments are not fully effective and have complications for Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). Botulinum toxin A (BTX-A) can be used to manage RP, but the literature mostly includes case reports and case series. Thus, we performed a randomized controlled trial to explore the efficacy of BTX-A in the treatment of RP secondary to SSc. Sixteen patients with RP secondary to SSc were recruited. One hand was randomly included in the BTX-A group and the other as control. Both hands were tested before treatment and 4 weeks later using qualitative and quantitative dermatoscopic assessments and the cold water test. Reynolds score (from 6.7 ± 4.0 to 2.9 ± 3.7, p < 0.001), Tbase (from 25.8 ± 3.0°C to 27.9 ± 2.1°C, p = 0.031) and Tchange (from 2.1 ± 1.2°C to 4.5 ± 2.1°C, p < 0.001) in the experimental group were improved, while there were no improvements in Tbase and Tchange in the control group. In the experimental group, the sum of the six dermoscopic parameters was improved after treatment (from 4.00 (3.00, 5.75) to 3.00 (2.00, 5.00), p = 0.002); the nailfold capillary pattern staging was also improved (from 2.00 (2.00, 3.00) to 2.00 (1.00, 3.00), p = 0.004). There were no improvements in the dermoscopic assessment in the control group. None of the patients reported adverse reactions such as infection, hematoma, hand muscle weakness, allergic reaction and nerve injury. In conclusion, local injection BTX-A to treat RP secondary to SSc might be safe and effective.

High-Frequency Ultrasound for Long-term Safety Assessment of Poly-L-Lactic Acid Facial Filler.

BACKGROUND: Injectable poly- l -lactic acid (PLLA) is a new type of biodegradable dermal filler that has been utilized for soft tissue filling. However, there is no convenient and reliable method to assess the long-term safety of PLLA filler. OBJECTIVE: To assess the long-term safety of PLLA injection into nasolabial folds by high-frequency ultrasound and to select the ultrasonic probes with the most appropriate frequency. MATERIALS AND METHODS: After a 30-month PLLA injection into the deep dermis of the nasolabial fold, subjects were examined by high-frequency ultrasound with the 20 MHz and 50 MHz probes. RESULTS: Twenty subjects with nasolabial fold contour deficiency were enrolled in this study. After a 30-month PLLA injection in nasolabial folds, PLLA degraded entirely in 16 subjects (16/20, 80%), and abnormal echo in the skin was observed in 4 subjects (4/20, 20%) caused by undegraded PLLA microparticles, PLLA microparticles deposition, fibrous nodules, and granuloma. The 20-MHz probe is more appropriate than the 50-MHz probe for evaluating the adverse effects of PLLA injection. CONCLUSION: High-frequency ultrasound is a rapid, reliable, and noninvasive method to monitor the degradation condition of PLLA and the formation of papules and nodules associated with PLLA injection.

Cutaneous manifestations of the Coronavirus Disease 2019 (COVID-19): A brief review.

COVID-19, first appeared in December 2019 in Wuhan, China, has been spreading quickly throughout the world. We reviewed the evidence on cutaneous manifestations of COVID-19 based on PubMed database. The searching strategy was (COVID* or coronavirus*) and (dermatol* or skin* or cutaneous*). The publication time was limited to 2019 onward. After independent review by two authors, 14 studies with 228 confirmed cases were included in the analysis. A total of 60 patients developed skin rashes, and the age ranged from 8 to 84. Exanthematous eruptions potentially related to COVID-19 infection were highly variable and heterogeneous. Skin lesions mainly appeared erythematous, urticarial, and vesicular (chicken pox-like or varicelliform). Petechiae rash, livedo reticularis, and reactivation of oral HSV-1 were also observed in single cases. Newly reported eruptions like vascular lesions and peculiar (perniosis-like) skin lesions caused concern among dermatologists. Exanthems were widely distributed and were primarily located on the trunk. Associated symptoms, latency time, treatment, and prognosis were also carefully summarized. This study reviewed the recently published COVID-19 studies with skin manifestations, which may pave the way for further research.

Contributions of dermatologists to COVID-19 research: A brief systematic review.

Coronavirus disease 2019 (COVID-19) has been declared a pandemic. We conducted a systematic review to reveal the contribution of dermatologists in COVID-19 research. Two hundred and ninety-eight articles were included and classified into cutaneous manifestations of COVID-19, operating experience against COVID-19, mechanisms and treatment of COVID-19, disinfection and personal protective equipment (PPE)-related skin diseases, and other topics. The value of these articles and their impact on clinical impact were discussed and we hope that dermatologists can have a better understanding of these areas from this study.

Public interest in Raynaud's phenomenon: A Google Trends analysis.

Raynaud's phenomenon is a common disorder affecting body extremities and other vascular beds. As infodemiological methods have developed, online search tools could be used to explore the public interest of the disease. The study aimed to determine the annual trend, seasonal pattern, and associated topics of Raynaud's phenomenon. Google Trends was used to collect the data. "Raynaud syndrome" was selected as the search term. Data on monthly relative search volume (RSV) were collected from four selected countries (United States, United Kingdom, Australia, and New Zealand) and globally. Related topics were obtained, and annual-related topics were also collected for analysis. The maximum RSV appeared in January 2019, and the minimum value was observed in August 2011. The peak for RSV occurred in winter, and the bottom appeared in summer. In top related topics, "Maurice Raynaud" was the most related. In rising related topics, disease manifestations and autoimmune connective diseases were highly concerned. For annual-related topics, associated diseases were attracting more attention over time. The population is interested in related diseases, pathogenesis, and treatment. There was a peak in winter for searching and supported the importance of season variation on the impact of Raynaud's phenomenon.

Telangiectasia as a potential clinical marker of microvascular lesions in systemic sclerosis patients from EUSTAR data in China.

OBJECTIVES: To investigate the prevalence and clinical relevance of telangiectasia in Chinese patients with systemic sclerosis (SSc). METHODS: Data from 230 SSc EUSTAR patients from Peking Union Medical College Hospital (2009-2011) that fulfilled the 1980 American College of Rheumatology SSc classification criteria were prospectively collected. Demographic, clinical, and laboratory data were calculated between groups with and without telangiectasia, and a six-minute walk test, pulmonary function test (PFT), transthoracic echocardiography (TTE), right heart catheterisation (RHC) and modified Rodnan skin score (mRSS) were performed. RESULTS: 96 patients (41.7%) were diagnosed with telangiectasia. There were no significant differences between patients with and without telangiectasia based on gender, age at onset, Raynaud's phenomenon (RP) duration, or SSc classification. Disease duration both from RP onset of patients and from first non-RP manifestation of patients with telangiectasia was significantly longer than patients without (p<0.05). RP (97.9% vs. 90.3%), finger/toe sclerosis (96.9% vs. 88.1%), facial sclerosis (68.8% vs. 53.7%), digital ulcers (DUs; 40.6% vs. 23.1%), digital pitting (49.0% vs. 33.8%), joint contracture (20.8% vs. 10.4%) and erythrocyte sedimentation rate elevation (26.7% vs. 14.8%) were significantly greater in telangiectasia patients (p<0.05). There were no differences in autoantibody development between patients with and without telangiectasia (p>0.05). PFT showed that forced vital capacity (77.0±17.26 vs. 83.05±16.53, p=0.005) and diffusion capacity for CO of the lung (58.9±19.4 vs. 65.7±19.7, p=0.030) were lower, while forced expiratory volume ratio (87.02±7.8 vs. 84.33±7.1, p=0.029) was higher in SSc with telangiectasia. Pulmonary artery hypertension (PAH) prevalence (25.0% vs. 14.2%) was significantly greater in patients with telangiectasia. CONCLUSIONS: Telangiectasia are common in Chinese SSc patients and usually associated with DUs, RP, and PAH. Telangiectasia could be a clinical marker of microvascular disease in SSc.

Optimal dosage of botulinum toxin type A for treatment of glabellar frown lines: efficacy and safety in a clinical trial.

BACKGROUND: Various preparations of botulinum toxin type A (BTX-A) are used to reduces glabellar (frown) lines. However, dose-related safety and efficacy of intramuscular injections of a widely used, locally produced BTX-A in China has not been established. OBJECTIVE: Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A (Hengli BTX-A [HBTX-A]) intramuscular injections on glabellar lines. METHODS: Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo (n = 122), low-dose (n = 183), and high-dose (n = 183) treatment groups for injection with saline solution, 10 units and 20 units of HBTX-A, respectively, at 4 sites in the corrugator muscle and 1 site in the procerus muscle. Outcomes were recorded before treatment and after 7, 30, 60, and 120 days, including glabellar line severity at maximum contraction and relaxation. RESULTS: Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group (p < .05). Better efficacy was obtained in the high-dose treatment group. More participants developed adverse events after treatment with HBTX-A doses, than with the placebo (p < .05). CONCLUSION: Twenty-unit HBTX-A provided optimal improvement in glabellar lines, and its use might minimize injection frequency while maintaining acceptable safety.

Characteristic dermoscopic features of melasma.

OBJECTIVE: To discribe the characteristic dermoscopic features of melasma. METHODS: Totally 20 patients with typical clinical presentations of melasma were included in this study. The melasma lesion and its surrounding normal skin were evaluated using dermatoscope. RESULTS: Melasma lesions manifested light yellow brown uniform patches in all patients, among whom dark brown patches were found in 19 patients, capillary network in 14 patients,and coarse hair in 6 patients. In contrast, no light yellow brown uniform patch was found in the normal skin in all patients (P<0.001), among whom dark brown patches were found in 10 patients (P<0.001), capillary network in 12 patients (P>0.05), and coarse hair in 2 patients (P>0.05). CONCLUSION: Light yellow brown uniform patches and dark brown patches are two major dermoscopic features of melasma.

Application of cloud database in the management of clinical data of patients with skin diseases.

OBJECTIVE: To evaluate the needs and applications of using cloud database in the daily practice of dermatology department. METHODS: The cloud database was established for systemic scleroderma and localized scleroderma. Paper forms were used to record the original data including personal information, pictures, specimens, blood biochemical indicators, skin lesions,and scores of self-rating scales. The results were input into the cloud database. The applications of the cloud database in the dermatology department were summarized and analyzed. RESULTS: The personal and clinical information of 215 systemic scleroderma patients and 522 localized scleroderma patients were included and analyzed using the cloud database. The disease status,quality of life, and prognosis were obtained by statistical calculations. CONCLUSIONS: The cloud database can efficiently and rapidly store and manage the data of patients with skin diseases. As a simple, prompt, safe, and convenient tool, it can be used in patients information management, clinical decision-making, and scientific research.

[Evaluations and analyses of quality of life in 90 patients with systemic sclerosis by health assessment questionnaire-disability index].

OBJECTIVE: To evaluate health-related quality of life (HRQOL) in patients with systemic sclerosis (SSc) using health assessment questionnaire-disability index (HAQ-DI), visual analog scale (VAS) and scleroderma assessment questionnaire (SAQ). METHODS: The questionnaires of HAQ-DI, VAS and SAQ were administered to 50 controls and 90 SSc patients from September to December 2013. And SSc patients were also evaluated for subset (limited & diffuse SSc), age, disease duration, autoantibodies and skin & internal organ involvement. RESULTS: The physical summary scores of HAQ-DI in dressing, cleaning and hand functions domains were higher in SSc patients than those in controls (all P < 0.05). As for VAS, the specific clinical manifestations (Pain,0.60 (0.20-1.40); Raynaud's phenomenon, 9.00(4.00-11.00); finger ulcers, 1.00(0.00-5.00); gastrointestinal symptoms, 5.00(1.00-6.50); respiratory symptoms, 3.00(0.00-6.00)) of SSc patients impacted their HRQOL. SAQ showed higher scores in blood vascular, respiratory, digestive and musculoskeletal systems for SSc patients (1.00(0.75-1.50), 0.50(0.33-0.67), 0.40(0.20-0.80), 0.13(0.00-0.38) vs 0.00(0.00-0.00), all P < 0.05). CONCLUSIONS: HRQOL is impaired in patients with SSc, especially in physical domains. And higher scores in SSc patients with specific organ involvement suggest that severe disease has worse HRQOL.

[Roles of dermoscopy in differential diagnosis of psoriasis and eczema].

OBJECTIVE: To describe the dermoscopic patterns of plaque psoriasis and chronic eczema and explore the roles of dermoscopy in their diagnosis and differential diagnosis. METHODS: A total of 68 patients with plaque psoriasis or chronic eczema were recruited from our department from December 2013 to May 2014 to undergo dermoscopic and histopathological examinations. Dermoscopic features of vascular morphology, vascular arrangement, background color, scale color and scale distribution were evaluated. Sensitivity, specificity, positive predictive value and negative predictive value were calculated for predefined dermoscopic criteria in relation to the diagnosis of plaque psoriasis. RESULTS: Thirty-one patients with plaque psoriasis and 37 patients with chronic eczema were included. Dotted vessels in a regular arrangement (sensitivity 80.6%, specificity 73.0%) over a light red background (sensitivity 71.0%, specificity 75.7%) and white scales (sensitivity 71.0%, specificity 83.8%) were highly predictive for the diagnosis of plaque psoriasis. And chronic eczema more commonly showed yellow scales and dotted vessels in a patchy arrangement over a dull red background. Characteristic vascular structures of hairpin vessels and red loops were also found to be highly specific (91.9%, 94.6%) for the diagnosis of psoriasis. CONCLUSIONS: Plaque psoriasis shows specific dermoscopic patterns compared with chronic eczema. And dermoscopy is valuable in the diagnosis and differential diagnosis of psoriasis.

[Roles of dermoscopy in the diagnosis and differential diagnosis of scalp psoriasis and seborrheic dermatitis].

OBJECTIVE: To describe the dermoscopic patterns of scalp psoriasis and seborrheic dermatitis and explore the roles of dermoscopy in their diagnosis and differential diagnosis. METHODS: A total of 40 patients with scalp psoriasis (n = 20) and seborrheic dermatitis (n = 20) were recruited from Department of Dermatology, Peking Union Medical College Hospital from December 2013 to May 2014. They were examined both dermoscopically and histopathologically. And characteristic dermoscopic features were evaluated. Sensitivity, specificity, positive predictive value and negative predictive value were calculated for predefined dermoscopic criteria in relation to the diagnosis of two diseases. RESULTS: The most significant dermoscopic features of scalp psoriasis included dotted vessels (10/20, 50%), glomerular vessels (13/20, 65%), red loops (16/20, 80%), hairpin vessels (17/20, 85%), white scales (10/20, 50%) and punctate hemorrhages (12/20, 60%). In contrast, seborrheic dermatitis was characterized by arborizing vessels (16/20, 80%), atypical red vessels (13/20, 65%), featureless areas (20/20, 100%) and honeycomb pigment (9/20, 45%) (all P < 0.05). CONCLUSIONS: Scalp psoriasis and seborrheic dermatitis have different dermoscopic patterns. Dermoscopy may be valuable for clinical diagnosis and differential diagnosis of scalp psoriasis and seborrheic dermatitis.

[Clinical characteristics of drug hypersensitivity syndrome in 10 patients].

OBJECTIVE: To characterize the clinical characteristics of drug hypersensitivity syndrome (DHS). METHODS: The clinical characteristics of 10 DHS patients admitted into our hospital were analyzed retrospectively. And the occurrence patterns of DHS were summarized. RESULTS: There were 4 males and 6 females with an age range of 17 to 66 years. Suspected drugs were anticonvulsants (n = 5), allopurinol (n = 2), antibiotics (n = 1), acetaminophen (n = 1) and unknown (n = 1). All cases developed skin rashes with fever within 14 to 60 days (n = 10). Lymphadenopathy was observed (n = 6). Morbilliform eruption was most common skin rash (n = 6); facial swelling was also appeared (n = 7). Eosinophilia was observed in all cases (n = 10). Liver involvement was common (n = 9). Autoimmune antibodies abnormality was uncommon; viral infection was complication in several cases. Glucocorticoids were applied in all cases (n = 10), 3 severe cases were administrated with intravenous immunoglobulin (IVIg). The clinical outcomes included discharging with recovery (n = 7), later diagnosed of non-Hodgkin lymphoma (n = 2) and in-hospital death (n = 1). CONCLUSIONS: The clinical manifestations of DHS are complicated. And the common reactive drugs include anticonvulsants, allopurinol, antiinflammatory drugs and antibiotics. Some cases may be misdiagnosed and long-term follow-ups are required.

[Establishment of enzyme-linked immunosorbent assay in the detection of BP180NC16A-specific IgE and its significance in bullous pemphigoid].

OBJECTIVE: To establish a method of detecting circulating immunoglobulin E (IgE) autoantibodies for BP180NC16A and evaluate its significance in bullous pemphigoid (BP). METHODS: GST-NC16A fusion proteins were expressed in Escherichia coli using the pGEX-2T expression system and purified by glutathione affinity chromatography.For optimal working conditions of enzyme-linked immunoabsorbent assay (ELISA), checkerboard titrations were performed with serial dilutions of antigen. Also optimized dilution of secondary antibody was confirmed. Sera samples from 56 patients with BP, 24 healthy controls, 18 with pemphigus and 1 with Stevens-Johnson syndrome at our hospital during February 2011 to October 2012 were examined by the modified ELISA approach. The optimal cut-off point for a positive result was selected with receiver operating characteristic analysis. RESULTS: The optimized ELISA was performed with plates coated with 500 µg/ml GST-NC16A. And the optimal dilutions of sera samples and secondary antibody were 1: 10 and 1: 1000 respectively. According to the established cut-off value (0.549), 40 of 56 BP patients and none of controls had detectable levels of BP180NC16A IgE. CONCLUSION: The established ELISA provides a highly specific tool for the detection of IgE anti-BP180NC16A in BP patients.

Safety and efficacy of Pimecrolimus in atopic dermatitis among Chinese infants: a sub-group analysis of a five-year open-label study.

INTRODUCTION: Atopic dermatitis (AD) exhibits difference in immune polarization between Caucasians and Asian races due to which an evaluation of the efficacy and safety of Pimecrolimus (PIM) in Asian population is called for. The current study addresses the need via a sub-group analysis of the PETITE study (NCT00120523) to evaluate the safety and efficacy of PIM in Chinese infants. MATERIALS AND METHODS: Patients with AD (≥3 months-<12 months of age) were randomized in a 1:1 ratio to either PIM 1% cream or topical corticosteroids (TCS). The primary endpoint was safety. The secondary endpoint was efficacy. RESULTS: 120 patients were randomized to either PIM 1% or TCS (n = 61 for PIM, n = 59 for TCS). The most often reported adverse events were reported by similar proportions of patients treated with PIM or TCS. There was a progressive increase in overall IGA treatment success in infants treated with PIM (82.9%, p < .05, 95% CI: 70.4, 95.3) after 26 weeks which was comparable to the TCS group (88.5%, p < .05, 95% CI: 79.8, 97.1). CONCLUSION: PIM showed an early and sustained efficacy in the Chinese sub-population with a substantial corticosteroid-sparing effect in patients with AD.