Improvement In Global Assessment Research Articles

Investigating the Use of 0.3% Adapalene/2.5% Benzoyl Peroxide Gel for the Management of Moderate-to-Severe Acne in Indian Patients: A Phase 4 Study Assessing Safety and Efficacy.

Background Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit associated with an increase in sebum secretion. Topical treatment with adapalene and benzoyl peroxide (BPO) is considered effective when used either as monotherapy or in fixed-dose combinations. However, the combination gel of 0.3% adapalene with 2.5% benzoyl peroxide (A0.3%+BPO2.5%) has not been evaluated in Indian patients with acne. This study aimed to evaluate the safety and efficacy of A0.3%+BPO2.5% gel in Indian patients with moderate-to-severe acne vulgaris. Methodology This was a 12-week prospective, multicenter, open-label, phase IV study conducted at six centers in India. Safety was assessed based on local tolerability (stinging or burning, erythema, dryness, and scaling) and any reported adverse events. Efficacy was evaluated based on reductions in the number of inflammatory and noninflammatory lesions, the Investigator's Global Assessment (IGA) scale, and the Global Assessment of Improvement (GAI) score. The patient-reported outcome was measured using the Subject Satisfaction Questionnaire. Results Of the 135 patients, 132 completed the study between December 24, 2021, and July 18, 2022 (93.9% had moderate acne; 6.1% had severe acne at baseline). The A0.3%+BPO2.5% gel was well tolerated. The reductions in the severity scores of erythema, scaling, and dryness from baseline to week 12 were 38.9%, 47.4%, and 76.5%, respectively. A targeted reduction of ≥50% in the number of inflammatory and noninflammatory lesions was achieved in 115 (87.1%) and 109 (82.6%) patients, respectively. Based on the investigator's responses to the IGA questionnaire at week 12, 28% and 40.9% of patients had clear and almost clear skin, respectively. Using the GAI scale, investigators reported that at 12 weeks from baseline, most patients presented with improvements in symptoms, such as erythema, scaling, and dryness, and none reported any worsening. Treatment satisfaction was rated as 91% by the patients. Conclusions The A0.3%+BPO2.5% gel effectively reduced the inflammatory and noninflammatory lesions and was found to be safe and well tolerated in Indians with moderate‑to‑severe acne vulgaris.

The role of upadacitinib for the treatment of axial spondyloarthritis.

Janus kinase inhibitors were recently approved for treatment of axial spondyloarthritis following clinical trials demonstrating benefit for symptom control. Upadacitinib treatment resulted in Assessment of SpondyloArthritis International Society 40 response improvement (defined as at least 40% improvement and an absolute improvement in global assessment of disease activity, patient assessment of back pain and other indices) in 45-52% of trial participants with axial spondyloarthritis. We review the data for efficacy and safety of upadacitinib in this patient population.

Efficacy and safety of crisaborole ointment in Chinese and Japanese patients aged ≥2 years with mild-to-moderate atopic dermatitis.

Atopic dermatitis is a chronic inflammatory skin disease with a significant impact on the overall wellbeing of patients and their families. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis in multiple countries. However, in the key pivotal trials, a low proportion of the overall patient population was Asian, therefore the safety and efficacy of crisaborole in the Asian population with atopic dermatitis remains unclear. CrisADe CLEAR was a multicenter, randomized, double-blind, vehicle-controlled, phase 3 study (NCT04360187) to assess the efficacy and safety of crisaborole ointment in Chinese and Japanese patients aged ≥2 years with mild-to-moderate atopic dermatitis involving ≥5% treatable body surface area. Patients were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. The primary endpoint was percentage change from baseline in the Eczema Area and Severity Index total score at day 29. Additional endpoints were improvement and success per Investigator's Static Global Assessment score at day 29 and change from baseline on the Peak Pruritus Numerical Rating Scale at week 4. Safety was assessed using rates of treatment emergent adverse events, serious adverse events, and clinically significant changes in vital signs and clinical laboratory parameters. Crisaborole-treated patients showed a significantly greater reduction versus vehicle in percentage change from baseline in Eczema Area and Severity Index total score at day 29 (P = 0.0002). Response rates for achievement of Investigator's Static Global Assessment improvement and success at day 29 were significantly higher for patients treated with crisaborole versus vehicle (P = 0.0124 and P = 0.0078, respectively). Crisaborole-treated patients showed a significantly greater reduction versus vehicle in change from baseline on the Peak Pruritus Numerical Rating Scale at week 4 (P = 0.0009). No new safety signals were identified. Treatment with crisaborole was effective and well tolerated in Chinese and Japanese patients with mild-to-moderate atopic dermatitis.

Post-operative management of inflammation after orthopaedic surgeries using trypsin, bromelain and rutoside combination: a single-centre prospective observational study

<p><strong>Background:</strong> Post-operative management of inflammation plays an important role in orthopaedic surgeries, as delay in wound healing may lead to extended hospital stay. Proteases like trypsin and bromelain combined with the bioflavonoid rutoside are often used to reduce post-operative pain and swelling. The present study aimed to evaluate the efficacy and safety of oral administration of a fixed dose combination of trypsin-bromelain-rutoside in the post-operative management after orthopaedic surgeries.</p><p><strong>Methods:</strong> The study was a prospective, observational data collection exercise. Hundred subjects undergoing orthopaedic surgeries, who were administered trypsin-bromelain-rutoside combination, were observed over a period of 8 days post-surgery. Verbal rating scales were used for grading the pain intensity and extent of swelling, while a 5-point Likert scale was used to evaluate patient- and investigator-reported global assessment of improvement in pain and swelling. Scores at day 3 and day 8 were analysed using paired t test.</p><p><strong>Results:</strong> At day 3 and day 8, the mean scores of pain and swelling were significantly reduced from baseline (all p<0.0001). By day 8, 74% of the patients achieved complete resolution of pain, while 50% reported complete resolution of swelling. By day 8, 54% patients reported excellent/ very good global improvement in pain and swelling, while the investigator reported excellent/ very good global improvement in 81% of the patients. No adverse event was reported in any of the patients.</p><p><strong>Conclusions:</strong> The combination of trypsin-bromelain-rutoside was safe and effective in reducing the post-operative pain and swelling after orthopaedic surgeries. An 8-day treatment led to complete resolution of pain in three-fourths of the patients and complete resolution of swelling in half the patients. The use of this combination has the potential to reduce hospital stay and pill burden.</p>

Endpoints in Vital Signs as a Useful Tool for Measuring Successful Needle Decompression After Traumatic Tension Pneumothorax: An Analysis of the National Emergency Medicine Information System Database.

Background Needle decompression is a useful tool in the pre-hospital setting for treating tension pneumothorax. However the specific improvements in vital signs that determine a successful decompression are only reported in a few studies and Emergency Medical Services (EMS) self-reported assessments of improvement are more commonplace. We hypothesize that EMS reports may exaggerate improvement when compared to objective vital sign changes. Methodology This is a retrospective cohort study using the National Emergency Medicine Information System (NEMSIS) for the year 2020.Vital signs recorded as objective endpoints include systolic blood pressure (SBP), pulse (HR), respiratory rate (RR), and oxygen saturation (SpO2). Univariate analysis was performed using the t-test for continuous variables and the chi-square test for categorical variables. Results A total of 8,219 calls were included in the sample size analyzed. Most patients were white (2,911, 35.4%) and male (6,694, 81.4%). Abnormal vitals recorded as indications for needle decompression included SBP <100 mmHg, HR <60 or >100 beats/minute, RR <12 or >20 breaths/minute, and SpO2 <93%. Statistically significant improvements were seen in the number of abnormal vital signs after the procedure. The percentage of improvement was higher in the EMS self-reported assessment than in objective findings for oxygen saturation and SBP. Conclusions Our analysis shows objective improvement of hypoxia and hypotension after field needle decompression, supporting the efficacy of the procedure. The improvement based on vital sign change is modest and is less than that reported by EMS assessment of global improvement.This represents a target for quality improvement in EMS practice.

Efficacy of basic body awareness therapy on functional outcomes: A systematic review and meta-analysis of randomized controlled trials.

This study examined the efficacy of basis body awareness therapy (BBAT) on functional outcomes and quality of life (QoL) in patients with mental health problems and long-lasting conditions including musculoskeletal disorders, chronic and psychosomatic pain, and neurological conditions. Randomized controlled trials (RCTs) were obtained from MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro from inception to April 1st, 2022. A random effects meta-analysis was performed to explore the efficacy of BBAT versus non-active and active control conditions. Eight RCTs (n BBAT=307, n controls=428) were included. There was no evidence for reductions in anxiety (standardized mean difference [SMD]=-1.42, 95% confidence interval [CI]=-3.30 to 0.46, p=0.14), depression (SMD=-0.82, 95% CI=-1.85 to 0.21, p=0.12), and no improvements in global assessment of functioning for functioning (GAF-F) (SMD=0.58, 95% CI=-0.03 to 1.19, p=0.06) or for symptoms (GAF-S) (SMD=0.76, 95% CI=-0.44 to 1.96, p=0.21) in BBAT versus non-active control conditions. BBAT reduced anxiety significantly more than active interventions (SMD=-0.84, 95% CI=-1.17 to -0.51, p<0.001). No significant differences between BBAT and active control conditions were found for reduction in depression (SMD=-1.16, 95% CI=-2.74 to 0.41, p=0.15) or in self-reported pain (SMD=0.08, 95% CI=-0.25 to 0.40, p=0.65). Active control conditions were superior in improving QoL (SMD=0.83, 95% CI=0.49 to 1.17, p<0.001), GAF-F (SMD=1.58, 95% CI=0.29 to 2.86, p=0.016) and GAF-S (SMD=1.19, 95% CI=0.85 to 1.53, p<0.001). Physiotherapists should be cautious in adopting BBAT, noting there is no high-quality evidence to support its' use to improve functionality and QoL in patients with mental health problems and/or long-lasting conditions.

Oral enzyme therapy using trypsin-bromelain-rutoside combination to counter pain and swelling in orthopaedic conditions: a single-centre experience

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Various orthopaedic conditions end up being painful, chronic and progressive, and are associated with persistent inflammation. The present study aimed to evaluate the efficacy and safety of an enzyme-bioflavonoid combination of trypsin-bromelain-rutoside in managing the chronic pain and swelling in out-patients with various orthopaedic conditions.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; The study was a prospective, observational study, conducted in 100 patients attending the orthopaedics department at a multi-speciality hospital located in Nashik, Maharashtra, India. Verbal rating scales were used for grading the pain intensity and extent of swelling at baseline and on days 3 and 8, after being prescribed oral tablets of trypsin-bromelain-rutoside combination. Scores were analysed using paired t test. A 5-point Likert scale was used to evaluate patient- and investigator-reported global assessment of improvement in pain and swelling at days 3 and 8.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; At baseline, 68 patients reported moderate-severe pain, while 74 patients had moderate swelling. The mean scores for pain and swelling showed statistically significant reduction at both day 3 (p&amp;lt;0.0001) and day 8 (p&amp;lt;0001). By day 8, 98 patients reported good-excellent improvement and the investigator reported good-excellent improvement in 97 patients. No adverse event was reported by any patient.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; The results indicate that this therapy led to significant improvement in the pain and swelling as early as day 3 and further improvement with continued therapy, and can, thus, provide a safe alternative in patients with various orthopaedic conditions and reduce the need for other analgesic and anti-inflammatory drugs.&lt;/p&gt;

Evaluation of the efficacy and safety of the 1064 nm picosecond Nd:YAG laser with a topically applied gold and diamond suspension for facial skin rejuvenation: A pilot study.

To investigate the efficacy and safety of combined treatment with a serum comprising a micro-diamond suspension and micro-gold cage with a 1064 nm picosecond neodymium-doped yttrium aluminum garnet (Nd:YAG) laser for facial skin rejuvenation. Topical serum was applied to the entire face and allowed to penetrate the skin and hair follicles for 20 min. Each participant was then treated with a 1064 nm picosecond Nd:YAG laser on the face. Photographs of each participant were taken at baseline, immediately after treatment, and 2 weeks after treatment using an imaging tool (Mark-Vu®; PSI PLUS, Suwon, Republic of Korea). Global improvement scores by two blinded investigators and participants' satisfaction scores were also assessed. The melanin index (MI), transepidermal water loss (TEWL), and skin hydration were evaluated using a device. Parameters associated with skin rejuvenation were assessed using Mark-Vu®. Adverse events were observed and reported by participants and physicians during the treatment and follow-up visit. At week 2, 40% (4/10) of the participants showed more than moderate clinical improvement in the investigator's global improvement assessment. No significant differences were observed in the MI, TEWL, skin hydration level, or skin parameters of Mark-Vu®. At week 2, 40% of the participants reported a high satisfaction score and minimal side effects. The novel topical facial serum comprising micro-diamond suspension and micro-gold cage is safe and effective when combined with laser treatment for facial rejuvenation.

Microneedle fractional radiofrequency for atrophic acne scars: In vivo evaluation of results by 3D analysis and reflectance confocal microscopy.

The efficacy of microneedle fractional radiofrequency (MFR) for the treatment of atrophic acne scars has been recently described, but accurate in vivo microscopic documentation of the processes occurring has never been reported. The aim of this study is to describe in vivo morphological atrophic acne scars' variations after treatment with MFR by means reflectance confocal microscopy (RCM) and three-dimensional (3D) imaging. A total of 11 patients requiring treatment for atrophic facial acne scars were treated with four monthly sessions of MFR. 3D imaging and RCM were assessed at baseline and 1month after last session. Clinical improvement, according to Global Assessment Improvement Scale, and patients' satisfaction were evaluated. Clinical improvement was observed in all the treated patients, although better results were obtained for boxcar scars (p=0.043). 3D imaging revealed a significant improvement in terms of mean scars' depth (p<0.001). Otherwise, RCM highlighted collagen remodeling with restoration of a reticular structure. Our study confirms the efficacy and safety of MFR in acne scars' treatment and provides the microscopic description of the results using RCM.

A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients

BackgroundConstipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by comparing with placebo among palliative cancer patients with constipation.MethodsThis is a randomized, double-blind, placebo-controlled trial. Participants aged over 18 were recruited and randomized to MZRW or placebo group in addition to current prescriptions (including ongoing laxatives treatment) for two weeks. Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month. Individualized modification of MZRW was allowed according to the traditional Chinese medicine (TCM) pattern of patient. The primary outcome was the global assessment of improvement, which reflected whether the constipation had improved, remained the same or worsened.ResultsSixty patients, with mean age 75.2 years (range 47–95 years), were randomized to MZRW or placebo group. Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022). Besides, the MZRW group had significant increase in stool frequency, and reduction in constipation severity and straining of defecation (p-value < 0.05). No serious adverse event was reported due to the research medication.ConclusionThis pilot trial suggests modified MZRW is well-tolerated and effective for relief of constipation in patients with advance cancer. It could be considered as a potential treatment option for constipation in palliative care.Trial registration: The trial had been registered in ClinicalTrials.gov with identifier number NCT02795390 [https://clinicaltrials.gov/ct2/show/NCT02795390] on June 10, 2016.

A comparative study of efficacy and safety of topical 10% phenylalanine gel versus 0.1% mometasone furoate cream in limited nonsegmental vitiligo

Background: Among various therapeutic options for treating vitiligo, the search for an effective agent to minimize disease progression and achieve repigmentation continues. Topical phenylalanine 10% gel has shown promising results, and hence this study was carried out in patients with limited vitiligo. Aim: To compare the efficacy and safety of topical 10% phenylalanine gel versus topical 0.1% mometasone furoate cream in patients with limited nonsegmental vitiligo. Materials and methods: This study included 74 participants diagnosed as limited nonsegmental vitiligo (≤5 skin lesions). Group A received topical 10% phenylalanine gel (twice daily application), whereas Group B received topical 0.1% mometasone furoate cream (once daily application) for a period of 16 weeks. Clinical improvement based on vitiligo area severity index (VASI) scoring was assessed at intervals of 4 weeks until the end of the study duration. Physician’s global improvement assessment was calculated at the end of the study based on VASI scores. Results: Group A participants showed improvement of 24% when compared with 30.7% in group B at end of 16 weeks. Reduction in VASI scores and clinically visible improvement were noted in both groups after 8 weeks. Adverse events were not noted in any of the groups. Lesions over hands and feet were 11.3 times less likely to show response to treatment when compared with other sites. Conclusion: Both phenylalanine and mometasone were able to achieve significant repigmentation in the participants without any adverse effects. Mometasone achieved marked to excellent response in a higher percentage of participants. The overall efficacy of topical mometasone cream was better than topical phenylalanine gel.

Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial

BackgroundIrritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD).MethodsThis study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc.ResultsA standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine.ConclusionThe protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol.Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1

A Nonviable Probiotic in Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

The aim of this study was to investigate the effectiveness of oral treatment with a nonviable probiotic lysate (BL) of Escherichia coli (DSM 17252) and Enterococcus faecalis (DSM 16440) in patients with irritable bowel syndrome (IBS). A phase IV, randomized, double-blind, placebo-controlled, multicenter (30 study sites), parallel group study was conducted in 389 patients of both sexes with IBS according to Rome III criteria. The treatment period was 26 weeks. The participants were allocated to either placebo or BL after a 2-week baseline period. The primary outcome was based on the European Medicines Agency IBS guideline: improvement in global assessment (GAI) and improvement in abdominal pain. Patients (BL, n= 191; placebo, n= 198) had similar baseline values and dropout rates. Overall, the response was similar between BL and placebo for IBS-GAI (17.4% and 14.4%, respectively; P= ·4787) and abdominal pain (42.0% and 35.4%, respectively; P= ·1419). Some secondary outcome measures and sensitivity analyses pointed toward potentially higher sensitivity of the abdominal pain measures in diarrhea-predominant IBS (IBS-D) but not the other subtypes. For the GAI, no subgroup differences were detected. For IBS-D, post hoc analyses for abdominal pain response over time and stool consistency showed potentially promising effects of BL. Finally, the treatment with BL was well-tolerated. BL is not effective across all IBS subtypes. However, BL may offer a treatment option for IBS-D that needs verification by an adequately powered drug trial; EudraCT-No.: 2012-002741-38.

Topical preparations for the treatment of mild-to-moderate acne vulgaris: systematic review and network meta-analysis.

Acne is very common and can have a substantial impact on wellbeing. Guidelines suggest first-line management with topical treatments, but there is little evidence regarding which treatments are most effective. To identify the most effective and best tolerated topical treatments for acne using network meta-analysis. CENTRAL, MEDLINE, Embase and World Health Organization Trials Registry were searched from inception to June 2020 for randomized trials that included participants with mild/moderate acne. Primary outcomes were self-reported improvement in acne, and trial withdrawal. Secondary outcomes included change in lesion counts, Investigator's Global Assessment, change in quality of life and total number of adverse events. Network meta-analysis was undertaken using a frequentist approach. Risk of bias was assessed using the Cochrane Risk of Bias Tool and confidence in evidence was assessed using CINeMA. A total of 81 papers were included, reporting 40 trials with a total of 18089 participants. Patient Global Assessment of Improvement was reported in 11 trials. Based on the pooled network estimates, compared with vehicle, benzoyl peroxide (BPO) was effective (35% vs. 26%) for improving self-reported acne. The combinations of BPO with adapalene (54% vs. 35%) or with clindamycin (49% vs. 35%) were ranked more effective than BPO alone. The withdrawal of participants from the trial was reported in 35 trials. The number of patients withdrawing owing to adverse events was low for all treatments. Rates of withdrawal were slightly higher for BPO with adapalene (2·5%) or clindamycin (2·7%) than BPO (1·6%) or adapalene alone (1·0%). Overall confidence in the evidence was low. Adapalene in combination with BPO may be the most effective treatment for acne but with a slightly higher incidence of withdrawal than monotherapy. Inconsistent reporting of trial results precluded firmer conclusions.

Picosecond Laser treatment of Striae Distensae: In vivo Evaluation of Results by 3D Analysis, Reflectance Confocal Microscopy, and Patient's Satisfaction.

The efficacy of picosecond laser (PSL) in the treatment of striae distensae (SD) has been recently reported;otherwise, the base for this improvement has not been clarified yet. The aim of this study is to treat long-lasting SD with PLS and to describe their in vivo morphological variations after treatment using three-dimensional (3D) imaging and reflectance confocal microscopy (RCM). A total of 27 patients asking for treatment for SD were treated with four monthly sessions of PLS. Clinical improvement was estimated through a blinded evaluation performed by two independent dermatologists, Global Assessment Improvement Scale (GAIS), patients' satisfaction, 3D imaging, and RCM assessments at baseline and 6 months after the last laser session. Although a clinical improvement of SD was observed in 81.4% of patients according to physicians' GAIS, only 66.6% of patients reported subjective improvement and satisfaction after treatment (P = 0.04). 3D imaging revealed a significant improvement in terms of skin texture (P < 0.001) and mean SD depth (P < 0.001). Otherwise, RCM highlighted collagen remodeling and the appearance of new dermal papillae in all the treated SD compared with baseline. The present study confirms that PLS represents a safe treatment option for SD; herein,we report morphological documentation of skin variations after PLS treatment. Lasers Surg. Med. © 2021 Wiley Periodicals LLC.

Nonablative laser skin resurfacing for periorbital wrinkling—A case series of 16 patients

Many modalities have been described for the treatment of periorbital wrinkling. The purpose of this study is to quantify the improvement of periorbital wrinkling achieved by current nonablative modalities, using a fractional 1565nm Er:glass fiber laser. Our study is a retrospective two-center case series including 16 patients treated with nonablative laser for periorbital wrinkling at the Tel-Aviv Sourasky Medical Center in Israel and Laserplast Aesthetic Medicine Center in Italy between 2017 and 2019. Patients were assessed for objective and subjective improvement, patient satisfaction, side effect profile, and downtime. Improvement in average Fitzpatrick Wrinkle Scale scores (from 4.3 to 2.7 by ranking physician 1 and 3.8 to 2.4 by ranking physician 2, P<.001) was observed after 8weeks. Global Assessment Improvement Scale scores were 2.6 (physician 1) and 2.2 (physician 2) on average. This correlated to mild-moderate subjective sense of improvement by patients. Side effects and downtime were minimal. Our study suggests that current nonablative laser skin resurfacing technology offers a mild-moderate improvement in periorbital wrinkling.

Reflectance confocal microscopy for striae distansae treatment monitoring after CO2 fractional laser.

The aim of this study is to describe the efficacy and safety of CO2 fractional laser to treat striae distensae (SD), before (T0) and 1 month after the last laser session (T1), in patients following different protocols based on the number of laser sessions, ≤4 and > 4. Efficacy was estimated with global assessment improvement scale (GAIS) performed by both physicians and patients, reflectance confocal microscopy (RCM), dermatology life quality index (DLQI). Safety was evaluated through pain assessment and adverse events. Eighteen patients with SD were enrolled. Clinical improvement of SD was observed in all patients at T1, as compared to T0. Furthermore, a reduction of RCM features of SD was observed at T1, above all in patients receiving >4 treatments, as compared to T0. Interestingly, we describe herein a new RCM feature of SD, the "neat-wall", corresponding to a distortion of the normal dermo-epidermal junction (DEJ), with a well-demarcated margin. A significant improvement of DLQI (P-value = .007) was also registered after SD treatment. Adverse events included temporary erythema and edema. In conclusion, the current study confirms the efficacy and safety of fractional CO2 laser, proposing RCM features, such as parallel collagen fibers and the neat-wall, as potential markers of SD treatment response.

Photodynamic Therapy with δ-Aminolevulinic Acid and Blue Light for the Treatment of Actinic Cheilitis

ABSTRACTBackground: Actinic cheilitis is a common precancerous disorder of the lower lip caused by ultraviolet radiation. Photodynamic therapy (PDT) is a potential treatment for actinic cheilitis, however controlled clinical trials regarding this treatment are needed.Objective: To evaluate the safety and efficacy of PDT with blue light and topical δ-aminolevulinic acid (Levulan®) in the treatment of actinic cheilitis.Methods: We conducted a single center, investigator-initiated, nonrandomized, open-label, proof of concept study of PDT with blue light for the treatment of actinic cheilitis. We enrolled 24 subjects, 20 meeting inclusion and exclusion criteria. One subject withdrew from the study prior to treatment. The study consisted of a screening visit, one to three scheduled treatments, and two follow-up visits. The primary outcome was clinical improvement in actinic cheilitis from baseline, estimated as no (0%), mild (25%), moderate (50%), marked (75%), or excellent improvement (100%). Post-treatment assessment of swelling, erythema, flaking/scaling, crusting, vesiculation/pustulation, and erosion/ulceration was also recorded. Subjects completed the Dermatological Life Quality Index questionnaire, subject global assessment of improvement, and pain assessment at each visit.Results: 65% of subjects achieved clinical improvement of 75% or greater and 20% achieved 100% improvement by the end of the study. Treatments were well tolerated with minimal discomfort. Subjects experienced transient mild adverse effects.Conclusion: Overall, our study supports using PDT for the treatment of actinic cheilitis.

Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.

Background The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P < 0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P < 0.001). Conclusions According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.

Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients.

Background and Aims: Lactose intolerance (LI) is a global problem affecting more than half of the world’s population. An ultra-purified, high-concentration galacto-oligosaccharide, RP-G28, is being developed as a treatment for patients with LI. The efficacy and safety of RP-G28 in reducing symptoms of lactose intolerance were assessed in a blinded, randomized, placebo-controlled trial. Methods: In this multiclinical site, double-blinded, placebo-controlled trial, 377 patients with LI were randomized to one of two doses of orally administered RP-G28 or placebo for 30 days. A LI test and symptom assessment were performed at baseline and on day 31. The primary endpoint was a ≥4-point reduction or a score of zero on LI composite score on day 31. Voluntary milk and dairy intake and global outcome measures assessed patients’ overall treatment satisfaction and quality of life before therapy and 30 days after therapy. This study received Institutional Review Board (IRB) approval. Results: For the primary endpoint, 40% in the RP-G28 groups reported a ≥4-point reduction or no symptoms on LI symptom composite score compared to 26% with placebo (p = 0.016). Treatment with RP-G28 also led to significantly higher levels of milk and dairy intake and significant improvements in global assessments compared to placebo. RP-G28 but not placebo led to significant increases in five Bifidobacterium taxa. Conclusions: RP-G28 for 30 days significantly reduced symptoms and altered the fecal microbiome in patients with LI. Treatment with RP-G28 also improved milk/dairy consumption and quality of life and was safe and well tolerated.