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Drug and Chemical Toxicology Nov 2023The aim of the study was to assess the toxicity profile of extract and evaluate its wound healing activity.
AIM
The aim of the study was to assess the toxicity profile of extract and evaluate its wound healing activity.
METHODS
wound healing activity of extract (5% and 10%) was performed using Clonogenic and Scratch assays. The toxicity profile of extract ointment was evaluated on animals using acute toxicity and dermal toxicity tests. wound healing activity of extract ointment (5% and 10%) was used to determine tensile strength in the incision wound healing model.
RESULTS
Results exhibited that the extract was safe up to 2000 mg/kg per oral dose and non-reactive while applied topically. results showed that extract closed the wound gap created by 97.13% in 48 h. The clonogenic assay revealed that the surviving factor for HaCaT cells and MEF cells was 0.78 and 0.85 after treated with 10% concentrations of . The tensile strength exhibited by 5% and 10% groups was 395.4 g and 558.5 g in comparison to the control group.
CONCLUSION
Thus, extract can be used as an alternative safe drug therapy against topical wounds.
Topics: Rats; Animals; Selaginellaceae; Rats, Wistar; Plant Extracts; Ointments; Wound Healing
PubMed: 35635134
DOI: 10.1080/01480545.2022.2075378 -
European Journal of Ophthalmology Jan 2024The purpose of this study was to assess the use of topical tacrolimus ointment in preventing rejection in high-risk corneal grafts, when added to the standard... (Observational Study)
Observational Study
PURPOSE
The purpose of this study was to assess the use of topical tacrolimus ointment in preventing rejection in high-risk corneal grafts, when added to the standard immunosuppressive regimen.
METHODS
We conducted an observational, retrospective study using clinical data of high-risk patients subjected to penetrating keratoplasty, who were treated with topical tacrolimus ointment 0.2 mg/g twice a day plus topical dexamethasone 0.1 mg/ml 6 id and compared it with a similar control group treated with topical dexamethasone 0.1 mg/ml 6 id alone. High-risk status was attributed to patients with previous ipsilateral corneal graft failure, two or more quadrants with corneal neovascularization or an infectious or inflammatory corneal disease.
RESULTS
We analysed 53 patients in the trial group versus 53 patients in the control group, with similar age, baseline diagnosis and risk factors, and median follow-up times of 30 and and 24 months, respectively. Survival analysis showed a higher graft survival rate at all follow-up periods for patients treated with topical tacrolimus ( < 0.01). No adverse reactions were reported.
DISCUSSION
This study shows that topical tacrolimus ointment increases the survival rate of the graft if added to the previous topical steroid regimen in high-risk patients.
CONCLUSION
Topical tacrolimus is safe and effective in prolonging graft survival in high-risk patients.
Topics: Humans; Tacrolimus; Retrospective Studies; Ointments; Graft Rejection; Immunosuppressive Agents; Corneal Transplantation; Keratoplasty, Penetrating; Corneal Diseases; Dexamethasone; Administration, Topical
PubMed: 37128645
DOI: 10.1177/11206721231172236 -
Journal of the European Academy of... Jan 2024The 31 European Academy of Dermatology and Venereology (EADV) Congress took place between 7 and 10 of September 2022 in Milan, Italy.
Efficacy and safety of tirbanibulin 1% ointment in actinic keratoses: Data from two phase-III trials and the real-life clinical practice presented at the European Academy of Dermatology and Venereology Congress 2022.
BACKGROUND
The 31 European Academy of Dermatology and Venereology (EADV) Congress took place between 7 and 10 of September 2022 in Milan, Italy.
OBJECTIVES
We report presented clinical data on the efficacy/effectiveness, safety and tolerability of tirbanibulin 1% ointment that has recently been licensed for actinic keratosis (AK) of the face or scalp in adults.
METHODS
Summary of presentations given at the EADV Congress.
RESULTS
Prof. Pellacani presented two post hoc analyses from two phase-III trials with AK patients (NCT03285477 [N = 351] and NCT03285490 [N = 351]): A descriptive analysis of medical history, concomitant medications, and safety results confirming a favourable profile for tirbanibulin showing that number of baseline AK lesions was not correlated to severity of local skin reactions. The latter analysis showed that cases of tirbanibulin application site pain or pruritus were few, and most were found to be mild. Prof. Kunstfeld reported six real-life clinical cases in Austria showing good tirbanibulin effectiveness, safety and tolerability for the treatment of new or recurring AK lesions. Results demonstrated that after 2- to 4-month follow-up, tirbanibulin was well tolerated and effective in AK patients. Presentations by Dr. Patel confirmed good outcomes and tolerability of tirbanibulin in Olsen grade 1-2 AK (N = 12) and porokeratosis patients (N = 4) treated once daily for 5 consecutive days in the United Kingdom. Furthermore, real-world experience in solid organ transplant recipients (N = 2) demonstrated effectiveness of tirbanibulin in skin field cancerization treatment. A symposium sponsored by Almirall was conducted during the congress in which Dr. Hadshiew and Dr. Lear brought together their clinical experience in Germany and the United Kingdom respectively. Interesting clinical cases of 5 consecutive days of tirbanibulin treatment compared to other treatments were discussed with attendees, as well as current treatment needs of AK patients.
CONCLUSIONS
This article provides an overview of presentations and symposium discussions, summarizing key phase-III results and real-life clinical experience with tirbanibulin shared by dermatologists across Europe.
Topics: Adult; Humans; Keratosis, Actinic; Dermatology; Ointments; Venereology; Neoplasm Recurrence, Local; Treatment Outcome
PubMed: 38116638
DOI: 10.1111/jdv.19636 -
Supportive Care in Cancer : Official... Jun 2023Multikinase inhibitors (MKIs) treatment has been proven as a powerful strategy in cancer therapy. However, it is greatly hampered by its common adverse effect known as...
BACKGROUND
Multikinase inhibitors (MKIs) treatment has been proven as a powerful strategy in cancer therapy. However, it is greatly hampered by its common adverse effect known as hand-foot skin reaction (HFSR), especially in patients with moderate-to-severe HFSR.
OBJECTIVE
To investigate the clinical characteristics, histopathological features, treatment response, and bio-indicators of HFSR.
METHODS
We retrospectively reviewed the medical records of 102 patients with moderate-to-severe HFSR resulting from MKIs therapy.
RESULTS
The median time to development of moderate-to-severe HFSR was 18 days, which would be significantly affected by the type of MKIs and the history of HFSR. Notably, we found that HFSR was classified into three consecutive stages: erythematous lesion, yellow hyperkeratotic lesion with surrounding erythema, and hyperkeratotic lesion. Inflammation was observed in the first two stages of HFSR, but disappeared in the third stage; in contrast, the hyperkeratosis gradually became thicker from stage one to stage three. Moreover, topical medications were demonstrated as an effective therapy for HFSR, among which, the topical steroids and urea ointment treatment response rate was 37.14%, the Shouzu Ning Decoction (SND) treatment response rate was 65%, and the SND in combination with urea ointment treatment response rate was 75%, meanwhile, systemic therapies did not improve the therapeutic efficacy of topical medications alone. In addition, the serum levels of HMGB1 were found to be a potential indicator for tracking the healing process as well as predicting the prognosis of HFSR.
CONCLUSION
This study revealed the potential factors affecting the development of HFSR, evaluated the therapeutic response towards different strategies for treating HFSR, and identified a potential prognostic indicator of HFSR.
Topics: Humans; Retrospective Studies; Ointments; Protein Kinase Inhibitors; Treatment Outcome; Prognosis; Urea; Hand-Foot Syndrome; Phenylurea Compounds
PubMed: 37273007
DOI: 10.1007/s00520-023-07830-3 -
Journal of Traditional Chinese Medicine... Aug 2022To evaluate the clinical efficacy and safety of external application of Chinese herbal medicine (ex-CHM) for psoriasis vulgaris (PV). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the clinical efficacy and safety of external application of Chinese herbal medicine (ex-CHM) for psoriasis vulgaris (PV).
METHODS
Different search portals, including the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wanfang, SinoMed, clinicaltrials, PubMed, Cochrane Library, and Cochrane Central Register of Controlled Trials, were searched for randomized controlled trials (RCTs) that compared the ex-CHM intervention with other treatment protocols for PV, with available data as of November 25, 2020. The Review Manager 5.3 software was used for analysis.
RESULTS
Nineteen RCTs involving 1988 participants were included, of which twelve RCTs qualified for the Meta-analysis. The results showed that the addition of CHM bath to narrow-band ultraviolet B (NB-UVB) had a higher response rate [RR = 1.29; 95% CI (1.19, 1.40); P < 0.000 01]; lower psoriasis area severity index (PASI) [MD = -3.15; 95% CI (-4.79, -1.52); P = 0.000 2)], adverse reactions rate [RR = 0.32; 95% CI (0.15, 0.66); P = 0.002], and recurrence rate [RR = 0.48; 95% CI (0.30, 0.79); P=0.004] than NB-UVB alone. The addition of CHM fumigation to NB-UVB also showed a higher response rate [RR = 1.29; 95% CI (1.11, 1.49); P = 0.000 7] and lower adverse reactions rate [RR = 0.44; 95% CI (0.24, 0.79); P=0.006]. In addition, CHM bath could reduce the adverse reactions induced by 308 nm excimer laser and improve patients' quality of life better than phototherapy. CHM fumigation could improve the efficacy of calcipotriol ointment and reduce the adverse reactions. CHM fumigation combined with external washing plus acitretin showed better results than using acitretin alone. No statistical difference was observed between CHM external washing and calcipotriol ointment or CHM ointment and retinoic acids.
CONCLUSIONS
Current evidence showed that CHM bath and fumigation appeared to be efficient and safe for PV treatment. However, no definite conclusion could be drawn due to the low quality of included studies and thus more well-designed studies are needed for further assessment.
Topics: Acitretin; Drugs, Chinese Herbal; Humans; Ointments; Psoriasis; Randomized Controlled Trials as Topic
PubMed: 35848965
DOI: 10.19852/j.cnki.jtcm.20220617.001 -
Medicine Nov 2022Psoriasis is a kind of chronic inflammatory skin disease characterized by erythema, skin hyperplasia, scales and keratinocyte hyperproliferation. Psoriasis Vulgaris, the... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Psoriasis is a kind of chronic inflammatory skin disease characterized by erythema, skin hyperplasia, scales and keratinocyte hyperproliferation. Psoriasis Vulgaris, the most common kind of psoriasis, severely deteriorates the life quality of patients. Traditional Chinese Medicine (TCM) is a good choice for the treatment of psoriasis, which has been proved to be safe and effective, and may reduce the recurrence rate. In clinical practice, Liangxue Jiedu Runzhi (LJR) ointment can effectively treat mild and moderate psoriasis with blood-heat syndrome, but there is a lack of evidence-based medical evidence. This trial aims to evaluate the efficacy and safety of LJR ointment for the treatment of mild and moderate psoriasis with blood-heat syndrome.
METHODS
A multicenter, randomized, double-blind, placebo-controlled, and self-controlled clinical trial was carried out according to this paper. The symmetrical rashes of each subject were regarded as the target lesions and were randomly divided into a treatment group (LJR ointment group) and a control group (placebo group). The LJR ointment or placebo ointment were externally administered on bilateral symmetric rashes, twice a day for eight weeks. The follow-up examination was made for subjects every two weeks. The primary research finding was conveyed by Psoriasis Area and Severity Index (PASI) in 8 weeks. The secondary research finding includes adverse events.
RESULTS
46 subjects undergo this research project. The difference between PASI scores of the target lesions in the treatment group and control group is statistically significant were in 8 weeks (P < .001). The percentage of PASI 75 in treatment group and control group were 48% and 15% in week 8, respectively (x2 = 11.33, P < .05). No severe adverse events were reported.
CONCLUSIONS
LJR ointment was proved to have efficacy in the treatment of mild and moderate psoriasis with the blood-heat syndrome.
Topics: Humans; Ointments; Hyperplasia; Hot Temperature; Psoriasis; Double-Blind Method; Syndrome
PubMed: 36397446
DOI: 10.1097/MD.0000000000031784 -
Wound Repair and Regeneration :... Sep 2021Microbial contamination of wounds is a significant problem that delays healing, particularly when bacterial biofilms are present. A novel combination of pectinic acid...
Microbial contamination of wounds is a significant problem that delays healing, particularly when bacterial biofilms are present. A novel combination of pectinic acid (PG) + caprylic acid (CAP) was previously found in vitro to be highly effective in eradicating various pathogens in biofilms with minimal cytotoxicity. In this study, a novel wound ointment was formulated with PG + CAP and first assessed in vitro using a well-established biofilm eradication model. In vitro, the PG + CAP ointment was shown to be efficacious in reducing the microbial biofilms. This ointment was then tested in vivo in two pilot porcine wound healing models, with and without Staphylococcus aureus microbial challenge. Ointments were applied to each wound daily, and healing by wound closure area measurement was assessed weekly over 4 weeks. After 4 weeks, pigs were sacrificed and wounds were scored for reepithelialization, inflammation, granulation tissue, and collagen deposition. We compared PG + CAP to hydroxyethylcellulose + glycerol ointment base (control) and MediHoney (comparator). In the porcine microbial challenge model, the novel antimicrobial PG + CAP wound ointment rapidly eradicated bacterial organisms embedded in wounds, was safe and well-tolerated, and was associated with enhanced healing compared to ointment base and MediHoney. Specifically, the cumulative histopathology, reepithelialization of epidermis, and mature granulation tissue in the wound bed was significantly better with PG + CAP than with control and MediHoney treatments. This ointment warrants further study as a non-antibiotic ointment for use in treating a wide array of infected wounds.
Topics: Animals; Anti-Bacterial Agents; Anti-Infective Agents; Ointments; Swine; Wound Healing; Wound Infection
PubMed: 33956391
DOI: 10.1111/wrr.12922 -
Journal of the American Academy of... Aug 2023Safe and effective long-term topical treatments for atopic dermatitis (AD) remain limited. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Safe and effective long-term topical treatments for atopic dermatitis (AD) remain limited.
OBJECTIVE
In this phase 2a, single-center, intrapatient, and vehicle-controlled study, we examine the mechanism of action of crisaborole 2% ointment, a topical nonsteroidal PDE4 (phosphodiesterase-4) inhibitor, in a proteomic analysis of 40 adults with mild to moderate AD and 20 healthy subjects.
METHODS
Within the AD cohort, 2 target lesions were randomized in an intrapatient (1:1) manner to double-blind crisaborole/vehicle applied twice daily for 14 days. Punch biopsy specimens were collected for biomarker analysis at baseline from all participants, then from AD patients only at day 8 (optional) and day 15.
RESULTS
Compared to the vehicle, crisaborole significantly reversed dysregulation of the overall lesional proteome and of key markers and pathways (eg, Th2, Th17/Th22, and T-cell activation) associated with AD pathogenesis toward both nonlesional and normal skin. Significant clinical correlations were observed with markers associated with nociception and Th2, Th17, and neutrophilic activation.
LIMITATIONS
Study limitations include predominance of white patients in the cohort, relatively short treatment time, and regimented administration of crisaborole.
CONCLUSION
Our results demonstrate crisaborole-induced normalization of the AD proteome toward a nonlesional molecular phenotype and further support topical PDE4 inhibition in the treatment of mild to moderate AD.
Topics: Adult; Humans; Boron Compounds; Bridged Bicyclo Compounds, Heterocyclic; Dermatitis, Atopic; Ointments; Proteome; Proteomics
PubMed: 37054814
DOI: 10.1016/j.jaad.2023.02.064 -
Allergology International : Official... Jan 2024Delgocitinib ointment, a topical Janus kinase inhibitor, is used as treatment of patients with atopic dermatitis (AD) aged ≥2 years in Japan. Although initiating...
BACKGROUND
Delgocitinib ointment, a topical Janus kinase inhibitor, is used as treatment of patients with atopic dermatitis (AD) aged ≥2 years in Japan. Although initiating appropriate and early treatment upon the onset of AD in childhood is important, the safety and efficacy of delgocitinib ointment in infants with AD have not been established.
METHODS
This phase 3 study was conducted from October 2020 to June 2022 (number JapicCTI-205412). Eligible Japanese infants with AD aged 6 to <24 months received 0.25% or 0.5% of delgocitinib ointment twice daily for 52 weeks in an open-label uncontrolled manner. Topical corticosteroids were allowed to apply for worsening AD during the treatment period at the investigators' discretion.
RESULTS
A total of 22 infants were enrolled. Adverse events (AEs) were reported in 21 (95.5%) infants and were mostly mild. No treatment-related AEs were reported. The Modified Eczema Area and Severity Index (mEASI) score continuously decreased until week 4, and the score reduction was maintained until week 52. The mean percent changes in the mEASI score from baseline were -73.5% at week 4, -81.7% at week 28, and -81.9% at week 52. Delgocitinib was not detected in the plasma of most infants (68.2%-95.2%).
CONCLUSIONS
Delgocitinib ointment is well tolerated and effective for up to 52 weeks when applied to Japanese infants with AD.
Topics: Infant; Humans; Dermatitis, Atopic; Ointments; Treatment Outcome; Pyrroles; Double-Blind Method
PubMed: 37100717
DOI: 10.1016/j.alit.2023.04.003 -
Cirugia Y Cirujanos 2023To compare the protective effect of nitroglycerin ointment 2% and Dimethylsulfoxide (DMSO) in dorsal flaps of the rat.
OBJECTIVE
To compare the protective effect of nitroglycerin ointment 2% and Dimethylsulfoxide (DMSO) in dorsal flaps of the rat.
METHODS
A blind, experimental study was conducted in 24 male Wistar rats, with a mean weight of 320 (286-376) grams. Group 1: Control. Petrolatum jelly (Vaseline), n = 8, Group 2: Nitroglycerin (NTG) ointment 2% (Nitro-Bid, Altana Co.) n = 8, and Group 3: DMSO gel 90% (Neogen corp. Lexington KY, 40611), n = 8.
RESULTS
A total of 24 rats were operated on in the 6-month period of this study. Using a non-parametric Mann-Whitney U-test analysis, a statistically significant p was obtained between the control group and 2% NTG ointment, both in the area of necrosis and in the healthy area (p = 0.026). In contrast, the comparison between DMSO [CH3) 2SO] and the control group (p = 0.180) and between both study groups, with a p = 0.18, was not significant.
CONCLUSIONS
Our study concluded that there is a protective effect of 2% NTG ointment for flap survival in relation to the control group (petrolatum). DMSO administered topically did not show a protective effect, compared to the control group.
Topics: Rats; Male; Animals; Nitroglycerin; Dimethyl Sulfoxide; Ointments; Rats, Wistar; Necrosis; Petrolatum
PubMed: 37844881
DOI: 10.24875/CIRU.22000203