Delving into the Latest Updates on Betamethasone Dipropionate/Clotrimazole with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Betamethasone Dipropionate/Clotrimazole/Gentamycin Sulfate Cream, CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, Clotrimazole and Betamethasone Dipropionate Lotion

+ [5]

Target

CYP51A1 x GR

Mechanism

CYP51A1 inhibitors(Cytochrome P450 51 inhibitors), GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Infectious DiseasesSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

ParonychiaTinea CapitisTinea Pedis+ [2]

Inactive Indication

Tinea corporistinea cruris

Originator Organization

Merck & Co., Inc.

Active Organization

Tianjin Jinyao Pharmaceutical Co., Ltd.

Inactive Organization

Organon & Co.

Drug Highest PhaseApproved

First Approval Date

US (10 Jul 1984),

Tinea corporistinea crurisTinea Pedis

Regulation-

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Structure

Molecular FormulaC28H37FO7

InChIKeyCIWBQSYVNNPZIQ-XYWKZLDCSA-N

CAS Registry5593-20-4

View All Structures (2)

ABSTRACTIntroductionA rise in tinea cruris among Thai Naval Cadets has been observed. Clotrimazole powder has been shown to be effective as an adjunct treatment for tinea cruris; however, its efficacy as a monotherapy is limited.ObjectivesThe aim is to determine the efficacy of 1% clotrimazole cream versus 1% clotrimazole powder in treating tinea cruris.Material and MethodsA randomized trial was conducted at the Thai Naval Rating School, Chonburi, Thailand. Naval rating cadets with suspected tinea cruris were randomly assigned to one of two groups: 1% clotrimazole cream or 1% clotrimazole powder, and they were instructed to apply the related medication to the affected lesion twice daily for 4 weeks. Clinical and symptomatic evaluations were carried out at 4 and 8 weeks.ResultsAll 17 and 14 participants who received 1% clotrimazole cream and powder, respectively, were included. After 4 weeks, the clinical cure rates were 76.5% in the cream group and 85.7% in the powder group (P = .664). All participants were clinically cured within 8 weeks. The self-evaluation of itch severity using a visual analog scale (VAS) revealed no significant difference between the two groups (P = .343). The dermatology quality of life index decreased as clinical improvement was achieved in both the clotrimazole cream and powder groups (6.0 vs. 7.5 score reductions, respectively; P = .765). The score for sweat reduction was higher in the 1% clotrimazole powder group compared to the cream group (5.0 vs. 4.0, respectively; P = .006).ConclusionMonotherapy with 1% clotrimazole powder showed comparable efficacy to 1% clotrimazole cream. Furthermore, the powder treatment reduced sweat more effectively compared to the cream.

01 Jan 2024·European Journal of Pharmaceutical Sciences

A comprehensively validated IVRT method reliably discriminates sameness and differences between several topical clotrimazole creams

Article

Author: Rath, Seeprarani ; Kanfer, Isadore ; Wellington, Hannah

In vitro release testing (IVRT) has gained increasing acceptance for use as a biowaiver for topical products intended for local action. Whereas the United States Food and Drug Administration (US FDA) has issued product specific guidances (PSGs) recommending IVRT for several products, the PSG for clotrimazole cream does not include an IVRT option. However, an important requirement to include supplemental selectivity in the validation process as described in the recent FDA draft guidance on IVRT studies for topical drug products has generally been conspicuously absent in the published literature describing the application of IVRT as a biowaiver. Supplemental selectivity involves the comparison of a reference product and altered formulations containing the same strength of the active pharmaceutical ingredient (API). In order to demonstrate supplemental selectivity, cream formulation containing the same API (clotrimazole), at the same strength (1 %) and in the same dosage form (cream) but manufactured using different excipients were used. This will help assess the impact that excipients may have on the release rate of clotrimazole and whether the method is capable of identifying differences in the microstructure and arrangement of matter (Q3) as an important performance parameter. In addition, products containing <30 % or >40 % clotrimazole to serve as negative controls were also included for the discriminatory power assessment. Hence, the primary objective was to develop and validate a simple, reliable, reproducible, and cost-effective in vitro technique in accordance with the recent draft FDA guidance to assess the "sameness" of topical creams containing 1 % clotrimazole. An in vitro release testing (IVRT) system was used and an IVRT method was developed and accordingly validated. The validated IVRT method showed the potential to accurately measure the release from 1 % clotrimazole creams and demonstrated supplemental selectivity and appropriate discriminatory power to identify "sameness" and/ or differences.

01 Nov 2023·EXPLORE

The efficacy of complementary treatment with marshmallow (Althaea officinalis L.) on vulvovaginal candidiasis: A randomized double-blinded controlled clinical trial

Article

Author: Zomorodian, Kamiar ; Zareshahrabadi, Zahra ; Shojaei, Kobra ; Jaladat, Amir Mohammad ; Namjooyan, Foroogh ; Amini, Fatemeh ; Hashempur, Mohammad Hashem

BACKGROUNDVulvovaginal candidiasis is a common gynecologic infection, and recurring cases are yet incurable. This trial was based on Persian medicine to compare how effective marshmallow aqueous extract 4% plus clotrimazole 1% (CLOT-M) is compared to clotrimazole 1% vaginal creams on VVC.METHODSThis study randomly assigned 100 women with VVC into two groups. The target group (n = 50) was treated with CLOT-M while controls (n = 50) with clotrimazole vaginal creams for seven consecutive nights. Different VVC symptoms and signs, and yeast culture from vaginal discharge were evaluated as the outcome measures before the intervention and 7 and 30 days after.RESULTSThe efficacy of CLOT-M vaginal cream was assessed during the 1st and 2nd follow-ups, indicating a significant decrease in mean itching (P = 0.001 for both comparisons) and dyspareunia score (P = 0.001 and P = 0.04, respectively) as compared to treatment with clotrimazole vaginal cream. Moreover, after 7 days of the intervention, patients in the CLOT-M group experienced significant improvement in mean dysuria score compared to those in the control group (P = 0.001). Neither cream caused any significant adverse events.CONCLUSIONIt seems that CLOT-M vaginal cream had a significant effect on the VVC symptoms improvement, without any significant side effects. However, larger sample-sized trials are needed for more evidence-based judgment.

100 Deals associated with Betamethasone Dipropionate/Clotrimazole

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01CA05 D07CC01 S03CA06 D07BC01	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Paronychia	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	-
Tinea Capitis	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	-
Tinea Pedis	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	-
Tinea Versicolor	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	-
Vulvovaginitis	CN	Tianjin Jinyao Pharmaceutical Co., Ltd.	-