Efficacy and safety of topical minocycline foam (FMX101 4%) in treatment of Chinese subjects with moderate-to-severe facial acne vulgaris: A phase 3, multi-centre, randomized, double-blind, vehicle-controlled study.

BACKGROUND: FMX101 4%, as a topical foam formulation of minocycline, has been approved by US Food and Drug Administration for the treatment of moderate-to-severe acne vulgaris (AV). OBJECTIVE: To evaluate the efficacy and safety of FMX101 4% in treating Chinese subjects with moderate-to-severe facial AV. METHODS: This was a multi-centre, randomized, double-blind, vehicle-controlled phase 3 study in Chinese subjects with moderate-to-severe AV. Eligible subjects were randomized 2:1 to receive either FMX101 4% or vehicle foam treatment for 12 weeks. The primary efficacy endpoint was the change in inflammation lesion count (ILC) from baseline at week 12. The key secondary endpoint was the treatment success rate according to Investigator's Global Assessment (IGA) at week 12. RESULTS: In total, 372 subjects were randomized into two groups (FMX101 4% group, n = 248; vehicle group, n = 124). After 12 weeks treatment, the reduction in ILC from baseline was statistically significant in favour of FMX101 4%, compared with vehicle foam (-21.0 [0.08] vs. -12.3 [1.14]; LSM [SE] difference, -8.7 [1.34]; 95% CI [-11.3, -6.0]; p < 0.001). FMX101 4% treatment yielded significantly higher IGA treatment success rate at week 12 as compared to the control treatment (8.06% vs. 0%). Applying FMX101 4% also resulted in significant reduction in noninflammatory lesion count (nILC) versus vehicle foam at week 12 (-19.4 [1.03] vs. -14.9 [1.47]; LSM [SE] difference, -4.5 [1.74]; 95% CI [-8.0, -1.1]; p = 0.009). Most treatment-emergent adverse events (TEAEs) were mild-to-moderate in severity, and no treatment-related treatment-emergent serious adverse event (TESAE) occurred. Thus, FMX101 4% was considered to be a safe and well-tolerated product during the 12-week treatment period. CONCLUSION: FMX101 4% treatment for 12 weeks could lead to significantly reduced ILC and nILC, and improved IGA treatment success rate in Chinese subjects with moderate-to-severe facial AV. It also showed a well acceptable safe and tolerability profile.

Dermoscopic features of port-wine stains: A study of 264 cases.

BACKGROUND: Port-wine stains (PWS) occur in 0.3-0.5% of the population. However, the dermoscopic features of PWS have not been systematically studied. METHODS: Dermoscopic images of 264 cases with PWS were retrospectively analysed. RESULTS: Linear vessels were the most frequent dermoscopic features of PWS (42.0%). Other dermoscopic features were reticular vessels (28.0%), sausage-like vessels (13.6%), dots or globules vessels (9.1%) and mixed vessels (7.2%). Nonvascular morphology comprised white circles (13.6%) and whitish veil (38.3%). Sausage-like vessels and whitish veil were mainly present in the thickened type and in those with PWS aged ≥18 years; mixed vessels were mainly present in purple type of PWS. Dermoscopic features showed no significant difference between lesions located on different facial areas (V1, V2 and V3). Dots or globular vessels were more common in non-facial lesions (P < 0.0001). White circles were only found in the facial lesions, and the frequency of white circles and whitish veil was higher in the treated group than in the untreated group (P = 0.004 and P = 0.04, respectively). The frequency of white circles was significantly higher in the prior treated group than in the untreated group (P < 0.0001). CONCLUSION: There are various of dermoscopic features of PWS. The dermoscopic features of patients with PWS may correlate with age, subtype, location, prior treatment history and pulsed dye laser (PDL) resistance.

Lesion segmentation using 3D scan and deep learning for the evaluation of facial portwine stain birthmarks.

BACKGROUND: Portwine stain (PWS) birthmarks are congenital vascular malformations. The quantification of PWS area is an important step in lesion classification and treatment evaluation. AIMS: The aim of this study was to evaluate the combination of 3D scan with deep learning for automated PWS area quantization. MATERIALS AND METHODS: PWS color was measured using a portable spectrophotometer. PWS patches (29.26-45.82 cm2) of different color and shape were generated for 2D and 3D PWS model. 3D images were acquired by a handheld 3D scanner to create texture maps. For semantic segmentation, an improved DeepLabV3+ network was developed for PWS lesion extraction from texture mapping of 3D images. In order to achieve accurate extraction of lesion regions, the convolutional block attention module (CBAM) and DENSE were introduced and the network was trained under Ranger optimizer. The performance of different backbone networks for PWS lesion extraction were also compared. RESULTS: IDeepLabV3+ (Xception) showed the best results in PWS lesion extraction and area quantification. Its mean Intersection over Union (MIou) was 0.9797, Mean Pixel Accuracy (MPA) 0.9908, Accuracy 0.9989, Recall 0.9886 and F1-score 0.9897, respectively. In PWS area quantization, the mean value of the area error rate of this scheme was 2.61 ± 2.33. CONCLUSIONS: The new 3D method developed in this study was able to achieve accurate quantification of PWS lesion area and has potentials for clinical applications.

Photodynamic therapy for the treatment of port-wine stains in phakomatosis pigmentovascularis.

BACKGROUND: Phakomatosis pigmentovascularis (PPV) is a rare congenital syndrome. Only a few studies have reported the treatment of PPV, including a case using photodynamic therapy (PDT) to treat PPV-associated port-wine stains (PWS). OBJECTIVE: To investigating the efficacy and adverse effects of hemoporfin-PDT in PPV-associated PWS. METHODS: The efficacy and adverse effects in patients with PPV who underwent two sessions of hemoporfin-PDT from January 2019 to December 2022 were retrospectively analyzed. RESULTS: Twenty patients were included (13 females, 7 males, age range: 2-31 years; mean: 8.20 ± 8.92 years). Two, nine, seven, and two patients had PPV types Ia, IIa, IIb, and IIIa, respectively. After two treatments, the visual evaluation indicated the color of the PWS in 4, 5, 6, and 5 patients showed poor, fair, good, and excellent improvements, respectively. The combined good and excellent improvement rates in patients with PWS and pigmentary nevus overlapping in the same treatment area and in patients with PWS in the treatment areas only were 33.3% versus 87.5%, respectively, and were significantly different (p = 0.02). Minor side effects, such as edema, scabbing, hyperpigmentation, and blistering, were observed in some patients after PDT. CONCLUSION: Hemoporfin-PDT is an effective treatment for PPV-associated PWS. Patients with PWS and pigmentary nevus overlapping in the same treatment area showed poorer efficacy than patients with PWS in the treatment areas only.

Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension.

BACKGROUND: There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients. METHODS: In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12. RESULTS: At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician's Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs . 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs . 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. CONCLUSION: Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov , NCT05108766.

Efficacy of hemoporfin-mediated photodynamic therapy in treating Sturge-Weber syndrome associated port-wine stains: A retrospective study.

Background Sturge-Weber syndrome (SWS) is a rare condition associated with a GNAQ gene mutation, which affects neural crest cells. A pulsed dye laser (PDL) is a first-line therapy for SWS, but its outcomes are worse than those in patients with port-wine stains (PWS). Photodynamic therapy (PDT) is a promising therapeutic option for PWS. However, its use for PWS associated with SWS has rarely been studied. Aims To investigate the therapeutic and adverse effects of photodynamic therapy in treating SWS-associated PWS. Methods Patients with SWS and matched patients with large size facial PWS were included in this study. Both colorimetric assessment and visual evaluation were conducted to evaluate patients' responses to treatment. Results Colorimetric assessment (blanching rate) and visual evaluation (scores of colour improvement) showed that after two PDT treatments, the SWS and PWS groups had similar treatment responses (21.2% vs. 29.8%; 3.39 vs. 3.65; P = 0.18, P = 0.37). However, there was a significant difference in efficacy between patients with SWS with and without a treatment history (12.4 and 34.9%, respectively; P = 0.02), as well as between patients with lesions located on the central and lateral faces (18.5 and 36.8%, respectively; P = 0.01). Both the SWS and PWS groups experienced minor adverse effects, and the frequency of these effects was not significantly different between the two groups. Limitation The study was limited by a small sample size and the possibility of later onset of glaucoma. In addition, false-negative magnetic resonance imaging screening results for SWS could not be ruled out due to the young age of some participants. Conclusion Photodynamic therapy is a safe and effective therapeutic option for SWS-associated PWS. Patients without a treatment history, and lesions on the lateral face, responded well, demonstrating good efficacy.

Efficacy of hemoporfin photodynamic therapy for pulsed dye laser-resistant facial port-wine stains in 107 children: A retrospective study.

BACKGROUND: Port-wine stains occur in 0.3-0.5% newborns, mainly on the face and neck. Pulsed dye laser is recognized as the gold standard treatment; nevertheless, it is associated with a low cure rate and a high recurrence rate. AIMS: This study aims to evaluate the efficacy of hemoporfin photodynamic therapy for pulsed dye laser-resistant port-wine stains in children. METHODS: We studied 107 children who received hemoporfin photodynamic therapy for port-wine stains on the face and neck that were resistant to pulsed dye laser. After intravenous injection of 5 mg/kg hemoporfin, the local lesion was irradiated with 532 nm LED green light for 20 min with a power density of 80-100 mW/cm2. A total of 65 patients were given a second treatment after eight weeks. The efficacy and therapeutic responses were recorded at four days and eight weeks after each treatment. RESULTS: The efficacy was positively correlated with the number of treatments received; two treatment sessions yielded significantly better results compared to a single treatment with a response rate of 96.9%, a significant response rate of 50.8% and a cure rate of 21.5%, respectively (P < 0.001). After two treatment sessions, the efficacy was negatively correlated with age (P = 0.04). The efficacy for port-wine stains located on the lateral part was better than that of the central face (P = 0.04). The efficacy for the pink type was better than that for the red and purple types (P = 0.03). No allergic or systematic adverse reactions were reported. LIMITATIONS: No objective measurement data were available. CONCLUSION: Hemoporfin photodynamic therapy is effective and safe for pulsed dye laser-resistant facial port-wine stains in children.

5-aminolevulinic acid (ALA) photodynamic therapy successfully treated chronic vulvar eczema with multiple warts: A case report.

The skin barrier function of the female vulva is susceptible to chronic eczema. Currently, the primary treatment for local chronic eczema is topical corticosteroids. However, long-term corticosteroid treatment can further damage the skin barrier, resulting in bacterial or viral infections that complicate the condition. Once chronic eczema is associated with viral warts, medication choices are limited. In this case report, a patient with a ten-year history of chronic vulvar eczema became infected with human papillomavirus and eventually developed multiple warts. After three sessions of photodynamic therapy, all warts subsided, and her skin lichenification and pruritis improved.

Efficacy of influential factors in hemoporfin-mediated photodynamic therapy for facial port-wine stains.

Hemoporfin-mediated photodynamic therapy (HMME-PDT) is a vascular-targeted treatment for port-wine stains (PWS). However, the efficacy of this has varied and is difficult to predict. The objective of this study was to evaluate the efficacy of influential factors associated with HMME-PDT and provide a suitable method for predicting the efficacy. Patients with facial PWS who underwent HMME-PDT were retrospective analyzed. A total of 212 patients (93 males) with mean age of 13.01 ± 12.67 years (range, 1-51) years were included. There were 143 cases with red, 56 cases with purple, and 13 cases with hypertrophic-type PWS. The number of HMME-PDT sessions ranged 1-6. The excellent response rate after 1-4 PDT sessions was 9.4%, 17.6%, 32.7%, and 42.9%, respectively. The number of PDT treatments is associated with efficacy, and patients who underwent treatment with more than three sessions had response better than those who underwent treatment with less than three sessions (p = 0.003). Response to HMME-PDT in patients of different ages, previous treatment history, lip involvement, and vessels morphology showed significant differences after two treatment sessions (p = 0.001, 0.03, 0.014, and 0.001, respectively), while patients of different sex, subtype, lesion size, location (medial, lateral, or mixed), or non-vascular morphology showed no significant differences. Logistic regression analysis confirmed that the patients with lip hypertrophy (p = 0.002), history of more than five times prior treatment (p = 0.003), fewer PDT sessions (<3) (p = 0.000002), linear vessels (p = 0.007), and reticular vessels (p = 0.0003) showed association with poor response of HMME-PDT. In conclusion, HMME-PDT is an effective treatment for PWS. Patients who had underwent treatment for more than five times prior, lip hypertrophy, and linear vessels or reticular vessels under dermoscope showed association with poor efficacy.

Post treatment care in photodynamic therapy (PDT) of large facial port-wine stain (PWS) birthmarks.

Photodynamic therapy (PDT) has been proved to be an effective and safe treatment for port-wine stain (PWS) birthmarks in China, especially for lager facial lesions. However, excessive treatment, improper nursing and human errors can cause serious adverse reactions that might result in high risks of infection, thick scabs and scar formation. The understanding and implementing of good post treatment care play a critical role in preventing and minimizing adverse reactions. This article will discuss details of good practice for the post treatment care in PDT of PWS birthmarks.

Efficacy of the combination of minimally invasive CO2 laser incision with photodynamic therapy for infected epidermoid cysts.

BACKGROUND: There are three main techniques for the removal of epidermoid cysts: traditional wide excision, minimal excision, and punch biopsy excision. For inflamed cysts, the wall is more friable and, therefore, more difficult to remove completely. The classic surgical excision always leads to a long scar or high rate of recurrence. CO2 laser has been proven to result in minimal incision, less bleeding, no suture, and a smaller or no scar. Photodynamic therapy (PDT) has been proposed as an antimicrobial alternative for common and drug-resistant bacteria in nonspecific and multiple sites. It was also shown to be effective in accelerating healing and inhibiting excessive proliferation of hyperplastic scar. Thus, we combined minimally invasive CO2 laser incision with PDT for epidermoid cysts with infection. METHODS: Thirty-three patients had a total of 39 infectious cysts. Two of the patients withdrew due to the high cost after 1 treatment session. After local injection of anesthesia, a hole measuring 2-3 mm was made at the pore in the upper part of the cyst along skin texture by CO2 laser (power 5 W, surgical pattern). The contents of the cyst were extracted through the hole using a curette and compression with gauze. PDT was then performed immediately. A total of 3 PDT sessions were recommended. The overall clinical effects, recurrence rates, cosmetic outcomes, adverse events, and patient satisfaction were assessed. RESULTS: We achieved a 97% success rate in 31 patients with 34 lesions using a combination of minimally invasive CO2 laser incision with PDT. At the 6- to 12-month follow-up, 30 of the patients had excellent cosmetic outcomes and satisfactory therapeutic effect. Pain during the illumination process, which can be relieved by dynamic cold air, was the primary adverse event. CONCLUSION: Our results demonstrate promise for the combination of minimally invasive CO2 laser incision with PDT as a safe and effective therapy for epidermoid cysts with infection. This treatment can inactivate a wide range of microbes including gram-positive and -negative bacteria, without developing drug resistance. Furthermore, it can promote fast wound healing and reduce scar formation.

Satisfactory response of a back carbuncle to 5-aminolevulinic acid (ALA) photodynamic therapy: A case report.

Carbuncle, a collection of interconnected furuncles with multiple pustular openings, is usually caused by Staphylococcus aureus (S. aureus). In this condition, both skin and subcutaneous tissue of the lesion show severe inflammation. It often occurs in immunocompromized patients such as those with diabetes, nephritis, malnutrition, heart failure, hypogammaglobulinemia, exfoliative dermatitis, or pemphigus or those using corticosteroids for long-term. Antibiotics and aggressive debridement are the primary recommended treatments for carbuncle. We report a case of carbuncle that received satisfactory response, in which the inflammation subsided and the wound healed after the administration of ALA photodynamic therapy for three times.

Novel mutations in one allele in a Chinese family with neurofibromatosis type 1: Including a complex insertion-deletion mutation.

Neurofibromatosis type 1 (NF1) is a hereditary disease with variable clinical manifestations. This study was performed in a Chinese three-generation family containing two members with NF1. Two novel mutations, c.853_854insTC and c.1975_1976delinsTA, were identified in the same allele in both patients by direct sequencing. By reverse transcription polymerase chain reaction, we found that the NF1 transcript contained the first mutation instead of the second mutation, suggesting a pathological role of c.853_854insTC mutation. Case reports of patients with two NF1 mutations in the same allele have not been reported. Our findings expand the known spectrum of NF1 mutations and the ongoing recognition of different mutations may give insight into the mysterious NF1 pathogenesis.

Clinical and Molecular Characterization of NF1 Patients: Single-Center Experience of 32 Patients From China.

Neurofibromatosis type 1 (NF1) is a hereditary disorder caused by mutations in the NF1 gene. Detecting mutation in NF1 is hindered by the gene's large size, the lack of mutation hotspots, and the presence of pseudogenes.Our goal was to establish a sensitive, feasible, and comparatively economical protocol to detect NF1 mutations using blood samples.We developed a method to screen patients for mutations. Thirty-two NF1 patients from 32 unrelated families and 120 unrelated population-match controls were investigated in this study. Specific primers were designed for NF1 to avoid pseudogenes. NF1 mutations were detected by sequencing at the deoxyribonucleic acid (DNA) and complementary DNA (cDNA) levels, and multiplex ligation-dependent probe amplification (MLPA) and familial segregation analyses were used.Forty-four specific primers designed according to the NF1 structure were successfully used for polymerase chain reaction (PCR) and DNA sequencing, which was more feasible and useful than cDNA sequencing. Thirty distinct NF1 mutations were identified in 32 patients. Thirteen mutations were novel and most were frameshift mutations (33.3%). Mutations were detected at a rate of 93.8%.Our study suggests that this sensitive, feasible, and comparatively economical protocol is effective for the detection of NF1 mutations.