Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04771546
Status:
UNKNOWN
Last Update Posted:
2021-06-16
First Post:
2021-02-22
Brief Title:
Efficacy of Intravaginal Carboxymethyl-β-glucan and Polycarbophil on Low-grade Cervical Lesions GLUCANCIN
Sponsor:
Uriach Consumer Healthcare
Organization:
Uriach Consumer Healthcare
Study Overview
Official Title:
Evaluation of the Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil on the Regression of Low-grade Cervical Intraepithelial Lesions
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLUCANCIN
Brief Summary:
A therapeutic strategy to neutralize the evasion mechanisms of HPV Among these treatments are beta-glucans polysaccharides of beta-D-glucose that can influence the clearance of HPV The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally on the regression of low-grade cervical intraepithelial lesions CIN associated to HR-HPV infection
Detailed Description:
Background
Human papillomavirus HPV infection represents a significant source of morbidity and mortality worldwide High-risk oncogenic HPVs cause 997 of cervical cancers 80 of sexually active women will be infected with HPV at some point in their life Most of these infections are transitory and only if they are persistent and caused by a high-risk oncogenic HPV are they an important risk factor for the development of cervical intraepithelial lesions and invasive cervical cancer Immunity plays a key factor in eliminating HPV infection The innate immune response constitutes the first line of defense against infection during the early stages of infection promoting a cytokine-mediated inflammatory response which links innate immunity with the adaptive immune response HPV evasion of these immune defense mechanisms is critical for the persistence of the infection and leads to the development of preneoplastic lesions and ultimately to cervical cancer One of most promising treatments is beta-glucans that seem capable of affecting the course of HPV infection and consequently the progression of its associated intraepithelial lesions
Justification
β-glucans are a very diverse heterogeneous group of polysaccharides made up of D-glucose monomers linked by β-type glycosidic bonds
β-glucans have been previously described in bacteria fungi yeasts including brewers yeast plants and algae where they play an important structural role in the cell wall or reservoir
There are more than 6000 β-glucans studies At least 4 receptors have been identified in mammals for the recognition of these molecules lactosylceramide scavengers complement receptor 3 and dectin-1
Commercial production of 13-β-glucans has been carried out by cultivating bacteria yeasts fungi and plants
Recent studies focusing on their influence on cytotoxic and helper T cells APCs inflammatory pathways and oxidative burst using reactive oxygen species to kill cells have revealed that they may also have some anti-cancer properties Some efforts have been made in the field of cervical cancer prevention and it has been shown that β-glucans can also affect HPV infection Carboxymethyl β-glucan gel treatment was studied in a group of affected individuals by CIN1 This case-control study demonstrated that it has an anti-cervical cancer role in CIN1 regression In 2010 two studies were conducted on the topic of the influence of β-glucans on HPV-related lesions in the genital area The first study found that β-glucans can treat infection-related lesions and the second study revealed the efficacy of beta-glucan treatment for HPVCIN1 lesions These studies suggested that in addition to the anticancer effects of beta-glucans they also have some effects on infection by HPV the main cause of cervical cancer
On the other hand the local treatment of vaginal problems has been known since ancient times and more recently it has been favored over oral treatments due to the achievement of higher local concentrations of drugs and fewer interactions of the active principles and interference with the gastrointestinal tract Vaginal products are marketed in the form of tablets capsules pessaries or ovules and semisolid forms creams ointments and gels being available as products for the treatment and prevention of vaginal infections Conventional dosage forms are associated with poor distribution and retention primarily due to the self-cleaning action of the vagina Among the commercialized dosage forms semisolids in particular gels have been considered the preferred ones as they spread easily over the vaginal surface area Additionally due to their high water content they confer moisture and lubrication effects that help alleviate the symptoms of conditions associated with vaginal dryness
Bioadhesion refers to the binding of natural or synthetic macromolecules to a biological tissue Mucoadhesion is considered a particular case of bioadhesion whenever the binding occurs with mucous glycoproteins mucin or mucous membranes The translation of these concepts into pharmaceutical technology has been widely studied through the use of bioadhesive polymers Among the most used in vaginal formulations are polyacrylates such as carbomers and polycarbophils cellulose derivatives hydroxyethylcellulose HEC hydroxypropylcellulose HPC hydroxypropylmethylcellulose HPMC etc chitosan hyaluronic acid and its derivatives starch pectin natural gums and sodium alginate In addition to increasing the retention time of vaginal formulations thus promoting therapeutic duration and efficacy and improving patient comfort and adherence these excipients also allow controlled drug release thus improving local pharmacokinetics
Polycarbophil and carbomer polyacrylate vaginal applications have been specially studied in vitro and in vivo and have been included in various proprietary formulations as well as actual marketed products These polymers have the additional advantage of being acidic allowing the correction and maintenance of vaginal pH and their acid-buffering capacity has been explored as a strategy for the treatment of bacterial vaginosis and the prevention of vaginosis recurrence for prevent the proliferation of pathogens while promoting the restoration of the protective flora of Lactobacillus
Polycarbophil in particular has been widely used for its bioadhesive properties especially after a 1-3 polycarbophil gel was shown to maintain vaginal acidity for 3-4 days after a single application in postmenopausal women and A polycarbophil-carbomer vaginal gel was proven in women with suspected and confirmed bacterial vaginosis to show a reduction in vaginal pH in both trials and a high clinical cure rate in confirmed vaginosis cases compared to placebo
The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally on the regression of low-grade Cervical intraepithelial lesions CIN associated to HR-HPV infection
Human papillomavirus HPV infection represents a significant source of morbidity and mortality worldwide High-risk oncogenic HPVs cause 997 of cervical cancers 80 of sexually active women will be infected with HPV at some point in their life Most of these infections are transitory and only if they are persistent and caused by a high-risk oncogenic HPV are they an important risk factor for the development of cervical intraepithelial lesions and invasive cervical cancer Immunity plays a key factor in eliminating HPV infection The innate immune response constitutes the first line of defense against infection during the early stages of infection promoting a cytokine-mediated inflammatory response which links innate immunity with the adaptive immune response HPV evasion of these immune defense mechanisms is critical for the persistence of the infection and leads to the development of preneoplastic lesions and ultimately to cervical cancer One of most promising treatments is beta-glucans that seem capable of affecting the course of HPV infection and consequently the progression of its associated intraepithelial lesions
Justification
β-glucans are a very diverse heterogeneous group of polysaccharides made up of D-glucose monomers linked by β-type glycosidic bonds
β-glucans have been previously described in bacteria fungi yeasts including brewers yeast plants and algae where they play an important structural role in the cell wall or reservoir
There are more than 6000 β-glucans studies At least 4 receptors have been identified in mammals for the recognition of these molecules lactosylceramide scavengers complement receptor 3 and dectin-1
Commercial production of 13-β-glucans has been carried out by cultivating bacteria yeasts fungi and plants
Recent studies focusing on their influence on cytotoxic and helper T cells APCs inflammatory pathways and oxidative burst using reactive oxygen species to kill cells have revealed that they may also have some anti-cancer properties Some efforts have been made in the field of cervical cancer prevention and it has been shown that β-glucans can also affect HPV infection Carboxymethyl β-glucan gel treatment was studied in a group of affected individuals by CIN1 This case-control study demonstrated that it has an anti-cervical cancer role in CIN1 regression In 2010 two studies were conducted on the topic of the influence of β-glucans on HPV-related lesions in the genital area The first study found that β-glucans can treat infection-related lesions and the second study revealed the efficacy of beta-glucan treatment for HPVCIN1 lesions These studies suggested that in addition to the anticancer effects of beta-glucans they also have some effects on infection by HPV the main cause of cervical cancer
On the other hand the local treatment of vaginal problems has been known since ancient times and more recently it has been favored over oral treatments due to the achievement of higher local concentrations of drugs and fewer interactions of the active principles and interference with the gastrointestinal tract Vaginal products are marketed in the form of tablets capsules pessaries or ovules and semisolid forms creams ointments and gels being available as products for the treatment and prevention of vaginal infections Conventional dosage forms are associated with poor distribution and retention primarily due to the self-cleaning action of the vagina Among the commercialized dosage forms semisolids in particular gels have been considered the preferred ones as they spread easily over the vaginal surface area Additionally due to their high water content they confer moisture and lubrication effects that help alleviate the symptoms of conditions associated with vaginal dryness
Bioadhesion refers to the binding of natural or synthetic macromolecules to a biological tissue Mucoadhesion is considered a particular case of bioadhesion whenever the binding occurs with mucous glycoproteins mucin or mucous membranes The translation of these concepts into pharmaceutical technology has been widely studied through the use of bioadhesive polymers Among the most used in vaginal formulations are polyacrylates such as carbomers and polycarbophils cellulose derivatives hydroxyethylcellulose HEC hydroxypropylcellulose HPC hydroxypropylmethylcellulose HPMC etc chitosan hyaluronic acid and its derivatives starch pectin natural gums and sodium alginate In addition to increasing the retention time of vaginal formulations thus promoting therapeutic duration and efficacy and improving patient comfort and adherence these excipients also allow controlled drug release thus improving local pharmacokinetics
Polycarbophil and carbomer polyacrylate vaginal applications have been specially studied in vitro and in vivo and have been included in various proprietary formulations as well as actual marketed products These polymers have the additional advantage of being acidic allowing the correction and maintenance of vaginal pH and their acid-buffering capacity has been explored as a strategy for the treatment of bacterial vaginosis and the prevention of vaginosis recurrence for prevent the proliferation of pathogens while promoting the restoration of the protective flora of Lactobacillus
Polycarbophil in particular has been widely used for its bioadhesive properties especially after a 1-3 polycarbophil gel was shown to maintain vaginal acidity for 3-4 days after a single application in postmenopausal women and A polycarbophil-carbomer vaginal gel was proven in women with suspected and confirmed bacterial vaginosis to show a reduction in vaginal pH in both trials and a high clinical cure rate in confirmed vaginosis cases compared to placebo
The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally on the regression of low-grade Cervical intraepithelial lesions CIN associated to HR-HPV infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None