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"clobetasol"
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Topical tacrolimus orabase versus topical clobetasol propionate orabase in the treatment of symptomatic oral lichen planus: a pilot randomized study
by
Martins, M. A T.
,
Schroeder, F. M. M.
,
Pedraça, E. S.
in
Administration, Topical
,
Adult
,
Aged
2024
Objectives
This pilot study aimed to compare the efficacy of 0.1% tacrolimus and 0.05% clobetasol propionate in orabase for treating symptomatic oral lichen planus (OLP).
Materials and methods
Pilot, randomized, and controlled study conducted on 21 patients with symptomatic OLP, selected according to the clinical and histopathological criteria of Cheng et al. 2016. Twelve patients received 0.1% tacrolimus, and nine received 0.05% clobetasol, both in orabase for 30 days with a two-month follow-up. The patients were examined for scores of signs (ODSS), symptoms (VAS), quality of life (OHIP-14), anxiety (Beck Anxiety Scale), and treatment satisfaction (Hedonic Scale).
Results
Both treatments were effective in reducing ODSS, VAS, and Beck Anxiety Scale scores and performed well on the hedonic scale, yet without statistical difference between them. However, at the 1-month follow-up, patients in group Clobetasol showed a greater percentage reduction in ODSS score compared to baseline by 50% (
p
= 0.02) and significantly lower average values (
p
= 0.03) than those in group Tacrolimus. Longitudinal intragroup analysis revealed significant improvements over time in both groups for ODSS, and only in the tacrolimus group for OHIP-14 and Beck scores.
Conclusions
Both tested protocols were effective over a three-month follow-up. However, due to the lower cost of clobetasol propionate it can be considered the first-choice option. Tacrolimus in orabase formulation may be a promising alternative for refractory lesions that do not respond to topical steroids.
Clinical relevance
Managing symptomatic OLP is challenging. Comparisons between tacrolimus and clobetasol propionate in orabase formulations have not yet been thoroughly explored.
Journal Article
Evaluation of the efficacy of supplementary probiotic capsules with topical clobetasol propionate 0.05% versus topical clobetasol propionate 0.05% in the treatment of oral lichen planus (a randomized clinical trial)
by
Fakhr, Mariam
,
Abdelwhab, Amira
,
Salem, Sherifa Tarek
in
Administration, Topical
,
Adult
,
Advancing oral medicine
2025
Objectives
Probiotics are live microorganisms consisting of many bacterial species that have immunoregulatory functions. The effectiveness of probiotic administration in conjunction with topical corticosteroid application in oral lichen planus (OLP) treatment was evaluated.
Methods
Sixty OLP patients were enrolled in this study and divided into two groups. Group 1 (Probiotics’ group): probiotic capsules were administered twice daily, for 4 weeks in addition to topical clobetasol propionate application 0.05% four times daily. Group 2 (Control group): topical clobetasol propionate 0.05% was applied 4 times daily for 4 weeks. Thongprasom criteria, numerical rating scale and candidal load were evaluated.
Results
Significant reduction in the numerical rating scale as well as Thongprasom scale in the probiotic group when compared to the control group, after 2 and 4 weeks, and more significant reduction was observed after 2 weeks. No difference in the reduction of the candidal load was observed between the two groups, nevertheless, no topical antifungal was used in the intervention group.
Conclusions
Systemic administration of probiotics as a supplementary treatment with topical corticosteroid was effective regarding the reduction of; pain, Thongprasom scales, and candidal load. However, the effectiveness was more evident after 2 weeks when compared to 4 weeks resulting in: more rapid relief of symptoms, improving quality of life, in addition to their antifungal properties.
Trial registration
The current study was registered in
clinicaltrials.gov (ID: NCT04383236) 6-11-2023
.
Journal Article
A Comparison of Two Regimens of Topical Corticosteroids in the Treatment of Patients with Bullous Pemphigoid: A Multicenter Randomized Study
by
Sassolas, Bruno
,
Doutre, Marie-Sylvie
,
Tancrede-Bohin, Emmanuelle
in
Administration, Topical
,
Adrenal Glands - drug effects
,
Aged
2009
Superpotent topical corticosteroids (CS) have been demonstrated to improve bullous pemphigoid (BP) patients’ survival. We assessed whether a mild regimen using lower doses of topical CS and a shorter duration could improve the outcome of BP patients even more. Three-hundred and twelve BP patients were included in a multicenter randomized controlled trial and stratified depending on the extent of BP as moderate (n=134) or extensive (n=178). Patients were randomly assigned to the standard regimen (clobetasol propionate cream, 40g per day initially, with CS tapering over 12 months) or the mild regimen (10–30g per day), with CS tapering over 4 months. A noninferior rate of BP control was obtained with the mild regimen 156/159 (98%) as compared with the standard regimen 150/150 (100%; P=0.005). Event-free survival, that is, the combined outcome of deaths and life-threatening adverse events did not differ between the two treatment groups (P=0.77). However, upon adjusting through the Cox model for age and Karnofsky score, a strong beneficial effect of the mild regimen was observed in patients with moderate BP, with an almost twofold decrease in the risk of death or life-threatening adverse events relative to the standard regimen (hazard ratio=0.54; 95% confidence interval, 0.30–0.97; P=0.039). This mild regimen allows a 70% reduction of the cumulative doses of CS and improves BP patients’ outcome.
Journal Article
A Canadian Real-World Study of Fixed-DOSE combination of Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Moderate-to-Severe Plaque Psoriasis
•In phase 3 clinical trials, the fixed-dose combination of HP/TAZ effectively treated moderate-to-severe plaque psoriasis.•In real-world conditions to treat moderate-to-severe plaque psoriasis, a substantial proportion of patients using HP/TAZ experienced clear skin. Patients were generally satisfied with their treatment. HP/TAZ provides an option for treating moderate-to-severe plaque psoriasis.
A fixed-dose combination of HP/TAZ has demonstrated efficacy with a favorable safety profile for treating moderate-to-severe plaque psoriasis.
The present single-arm, open-label study evaluated the use of HP/TAZ in real-world practice.
Adults with moderate-to-severe psoriasis were enrolled and treated with HP/TAZ according to the Canadian label. The primary endpoint was the percentage of patients with treatment success at week 8, defined as an Investigator's Global Assessment score of clear or almost clear with a minimum 2-grade improvement.
202 patients received at least one dose of HP/TAZ, 138 patients had efficacy assessments at baseline and week 8. Treatment success was achieved by 26.1% and 43.5% of patients (week 4 and 8 respectively) . Patient-rated average and worst itch were 4.5 and 5.3 points at baseline, with a subsequent reduction to 1.7 and 2.1 points, respectively, at week 8. Patients were satisfied-very satisfied with the HP/TAZ. Application site reactions (13.4%) and dermatitis/eczema (3.5%) were the most frequently reported adverse events (mild-moderate in severity) .
The study design may limit generalizability of the results as an open label real world evidence study lacking a placebo or comparator arm.
Results confirm that HP/TAZ can be beneficial moderate-to-severe psoriasis patients.
Journal Article
Rebamipide for management of methotrexate-induced oral ulcers: a three-arm randomized clinical trial
2025
Objectives
This RCT aimed to evaluate the effect of topical Rebamipide (regular and nanoparticulated) in comparison to topical Clobetasol propionate in the management of methotrexate-induced oral ulcers in rheumatoid arthritis patients.
Materials and methods
Patients were divided randomly into three parallel arms: 1% Rebamipide; 1% nanoparticulated Rebamipide, Clobetasol propionate. The outcome measures included WHO oral mucositis grading, pain (NRS), ulcer size, and healing time. The data was analyzed for any statistical significance.
Results
Intragroup comparisons of mucositis grade improvement and pain reduction revealed significant differences in all the groups. All intergroup comparisons demonstrated non-significant difference, yet nanoparticulated Rebamipide was leading, and all group participants achieved complete healing earlier than the other groups.
Conclusion
Rebamipide, regular and nanoparticulated forms, showed comparable results to potent Corticosteroid, Clobetasol propionate in management of the oral ulcers.
Clinical relevance
Rebamipide is an efficient promising alternative modality for management of methotrexate-induced oral ulcers in rheumatoid arthritis patients.
Journal Article
Comparison of Systemic Mycophenolate Mofetil with Topical Clobetasol in Lichen Planopilaris: A Parallel-Group, Assessor- and Analyst-Blinded, Randomized Controlled Trial
by
Hejazi, Pardis
,
Lajevardi, Vahide
,
Azizpour, Arghavan
in
Administration, Cutaneous
,
Administration, Oral
,
Adult
2015
Introduction
Lichen planopilaris (LPP) is the most common cause of inflammatory immune-mediated cicatricial alopecia. If not diagnosed and treated properly, it may lead to irreversible hair loss with a devastating impact on quality of life. However, treatment can be a challenge. In an area lacking these sorts of studies, we conducted a randomized controlled trial (RCT) to study the tolerability and therapeutic effects of topical clobetasol versus systemic mycophenolate mofetil (MMF).
Methods
A randomized, assessor- and analyst-blinded controlled trial was conducted in 60 patients with LPP in Razi Dermatology Hospital, Tehran, Iran, between February and December 2013. Patients were treated with clobetasol lotion 0.05 % applied at night or oral MMF 2 g/day and were followed for 6 months. The Lichen Planopilaris Activity Index (LPPAI) was the primary measure of response to treatment.
Results
Systemic MMF and topical clobetasol were equally effective in reducing the LPPAI over 6 months of treatment. Treatment tolerability was excellent in both groups and no serious irreversible adverse effects were detected. Satisfaction with treatment rose in the MMF group over time; however, it declined in the clobetasol group.
Conclusion
Given the similar efficacy profiles, topical clobetasol seems to be a more suitable and reasonable choice for treatment of LPP than MMF.
Journal Article
Platelet‐rich plasma as a new and successful treatment for lichen planopilaris: A controlled blinded randomized clinical trial
by
Dehghani, Abbas
,
Ghassemi, Mohammadreza
,
Behrangi, Elham
in
Administration, Cutaneous
,
Adult
,
Alopecia - drug therapy
2024
Introduction Lichen planopilaris (LPP) is one of the most common causes of scarring hair loss caused by immune‐mediated inflammation resulting in atrophy and scaling. The key to preventing this irreversible hair loss is diagnosing and starting treatment at the earliest possible stage. As there is no definite cure for LPP, the therapy could be challenging. In the study, we conducted a single‐blinded randomized clinical trial to evaluate the therapeutic effects, safety, and tolerability of platelet‐rich plasma versus topical clobetasol in the treatment of LPP. Method A randomized single‐blinded controlled clinical trial was conducted in 24 LPP patients referring to our dermatology clinic between August 2022 and March 2023. Patients in the control group were treated with topical clobetasol 0.05% applied at night, and patients in the case group, in addition to topical clobetasol, received three sessions of PRP injection monthly. Both groups were assessed 1, 2, and 6 months after the start of the study by the Lichen Planopilaris Activity Index (LPPAI), physician and patient satisfaction, tolerability, and recording adverse effects. Results The average age in the clobetasol and PRP groups was 43.75 ± 13.51 and 42.75 ± 9.67, respectively (p = 0.83). In terms of gender, all 12 cases (100%) in the clobetasol group and 9 cases (75%) in the PRP group were female (p = 0.21). Both PRP and topical clobetasol effectively reduced LPPAI in the first 2 months; however, after 6 months, the LPPAI significantly increased in the clobetasol group (p = 0.001). There were no significant differences in LPPAI between the two groups at the beginning of the study and after 1 month. However, the mean LPPAI score in the clobetasol group was significantly higher than in the PRP group at 2 and 6 months after the start of the study (p = 0.01). Patient satisfaction with treatment increased in both groups during follow‐up sessions, but at the end of the follow‐up period, it was significantly higher in the PRP group (p = 0.03). Finally, the study did not have any serious adverse effects, and the pain experienced during PRP injection was tolerable for the patients. Overall, treatment tolerability was excellent in both groups. Conclusion Given the different efficacy profiles, PRP could be considered a new and effective choice for the treatment of LPP.
Journal Article
Comparative study between efficacy of topical tofacitinib 2% ointment versus topical clobetasol propionate 0.05% ointment in hand eczema at a tertiary hospital in central India version 1; peer review: awaiting peer review
by
Bhatt, Drishti
,
Singh, Dr Adarshlata
in
Administration, Topical
,
Adult
,
Clobetasol - administration & dosage
2024
Background
Hand eczema is a prevalent dermatological condition that significantly impacts the quality of life of affected individuals. Topical corticosteroids, such as Clobetasol Propionate, are commonly employed for management, but concerns regarding long-term use and potential side effects necessitate exploration of alternative treatments. This study protocol outlines a randomized controlled trial comparing the efficacy of topical Tofacitinib 2% ointment with Clobetasol Propionate 0.05% ointment in managing hand eczema.
Methods
The study will be a single-blinded, parallel-group, randomized controlled trial conducted at the Dermatology outpatient department of Acharya Vinoba Bhave Rural Hospital Sawangi Meghe, Wardha, from March 2023 to September 2025. Eligible participants diagnosed with hand eczema will be randomized into two groups: Group 1 will receive Clobetasol Propionate 0.05% ointment, and Group 2 will receive Tofacitinib 2% ointment. The primary outcome measure is the change from baseline in the Hand Eczema Severity Index (HECSI) score, assessed at two weeks and four weeks. Statistical analysis will utilize appropriate parametric and non-parametric tests, with a p-value <0.05 considered significant.
Expected Outcome
The study is anticipated to provide insights into the comparative efficacy and safety of Tofacitinib and Clobetasol Propionate in managing hand eczema. A favorable outcome for Tofacitinib could suggest its potential as an alternative or adjunctive therapy, offering a more targeted approach with fewer side effects. The findings may contribute to optimized treatment strategies for hand eczema, improving patient outcomes and guiding future research in dermatological therapeutics.
Journal Article
Time-Dependent Changes in Salivary Antioxidants After 5-ALA Photodynamic Therapy vs. Clobetasol in Oral Lichen Planus: A Randomized Clinical Trial
by
Pietruska, Małgorzata
,
Pietruska, Aleksandra
,
Żendzian-Piotrowska, Małgorzata
in
Adult
,
Aged
,
Aminolevulinic Acid - pharmacology
2025
In this randomized clinical trial, we compared the effects of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) and topical clobetasol on the salivary antioxidant profile in patients with oral lichen planus (OLP) and explored their relationships with clinical outcomes. Ninety adults with OLP were randomly allocated to ALA-PDT (five weekly sessions) or clobetasol (twice daily for 14 days). Unstimulated whole saliva was collected at baseline (T0), immediately after treatment (T1), and at 3 (T3) and 6 months (T6). The activities of catalase (CAT), superoxide dismutase (SOD), peroxidase (Px) and reduced glutathione (GSH) were determined, and nonparametric statistics were applied, including Friedman tests with Dunn’s post hoc comparisons and Spearman’s rank correlations. Both therapies induced an early decline in CAT, Px and GSH at T1, followed by partial recovery at later time points. SOD activity changed significantly over time in the clobetasol group, but not in the PDT arm. At T6, Px and GSH remained below baseline in both groups despite improvement from the immediate post-treatment nadir. No significant between-group differences were observed at individual time points, although GSH at T6 showed a non-significant trend favoring PDT. Exploratory analyses revealed modest, treatment-dependent associations between salivary antioxidant activity and lesion size, as well as between the former and pain intensity. Overall, ALA-PDT and topical clobetasol both modulated the salivary redox profile, primarily through short-term depletion of enzymatic and non-enzymatic antioxidants with incomplete recovery over 6 months, and no clear redox superiority of one modality over the other was demonstrated. These findings are hypothesis-generating and underscore the need for larger, longer-term studies with broader redox panels and more advanced between-group analyses.
Journal Article
Therapeutic effects of acyclovir and acyclovir-clobetasol nanofibers vs. cream formulation for recurrent herpes labialis
by
Mirzaei, Shahla
,
Mohammadi, Solmaz
,
Nejad, Zahra Golestan
in
Acyclovir
,
Acyclovir - administration & dosage
,
Acyclovir - therapeutic use
2024
Objectives
This study aims to compare the therapeutic effects of acyclovir nanofiber and acyclovir-clobetasol nanofiber formulations with their non-nano formulations (cream formulation) on recurrent labial herpes.
Materials and methods
Eighty patients with labial herpes lesions were divided into four groups, each receiving one of the following treatments: acyclovir-clobetasol nano patch, acyclovir-clobetasol cream, acyclovir nano patch, or acyclovir cream. Pain levels and recovery times were assessed. The Wilcoxon test compared pain levels, while the log-rank test compared healing and scabbing times.
Results
Acyclovir-clobetasol nanofiber and cream, along with acyclovir nanofiber, significantly reduced symptoms compared to the acyclovir cream. The recovery and scabbing times were shorter in patients who received acyclovir-clobetasol formulations compared to those receiving acyclovir alone.
Conclusion
Acyclovir-clobetasol combinations accelerated recovery times compared to acyclovir alone. Additionally, nanofiber formulations demonstrated enhanced healing efficacy over cream formulations.
Trial registration
This trial was retrospectively registered by Iranian Registry of Clinical Trials (IRCT) at 14/11/2023. Trial Registration number: IRCT20230926059521N1.
Journal Article