Development and evaluation of polymeric in situ gels of antifungal agents for oral candidiasis

ISRCTN	ISRCTN90634047
DOI	https://doi.org/10.1186/ISRCTN90634047
Secondary identifying numbers	N/A

Submission date: 01/06/2010
Registration date: 17/06/2010
Last edited: 12/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Harish Nairy
Scientific

Department of Pharmaceutics
NGSM Institute of Pharmaceutical Sciences
Paneer
Deralakatte
Karnataka
Mobile Tel: +91 (0)984 4897869
Mangalore
575 018
India

Phone	+91 (0)824 2203991
Email	harishnayari@gmail.com

Study information

Study design	2 centre single blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Development and evaluation of polymeric in situ gels of antifungal agents for oral candidiasis: A single blind, randomised controlled trial
Study objectives	1. To assess the effect of fluconazole in situ gels locally applied in the oral cavity on the number of Candida species 2. To assess the therapeutic efficacy of the dosage for in eradiation of local candidiasis 3. To estimate the drug release with respect to time in the oral cavity 4. To understand whether the present dosage will help to improve patient compliance using Likert's rating scale
Ethics approval(s)	Local medical ethics committee at A.B.Shetty Memorial Institute of Dental Sciences approved on the 25th of June 2008 (ref: ABSM/EC/18/2008)
Health condition(s) or problem(s) studied	Oropharyngeal candidiasis
Intervention	A bicenter, open-label, single blind clinical trial design was followed, to compare the efficacy of fluconazole in situ gel (0.5% w/v) with that of fluconazole tablets (100 mg) for 14 days. The patients with OPC were divided into 3 groups, each comprising of 15 patients. 1. Group I: comprised of patients having HIV/AIDS treated with in situ gel 2. Group II: comprised of patients with partial or complete dentures, treated with in situ gel 3. Group III (active control): comprised of patients with either HIV or partial/complete dentures were treated with fluconazole tablets 100 mg for 14 days given by oral route Following the initial (base line) visit, the subsequent visits were scheduled on day 3, day 7, day 14, day 22, day 34, and 44th day. The efficacy of the dosage form was compared with tablets for the successful clinical response and changes from baseline for the symptoms of OPC, which included the soreness erythema, extent of oral lesions and quantification of colony forming units (CFU) of Candida spp. Clinical assessment were made and recorded by a Registered clinical practitioners. The severity of baseline symptoms was assessed on a scale of 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe). The quantification of CFU of Candida spp., was done by taking oral swabs at three different locations. Oral swabs were then streaked on hichrome® medium. The specimen was examined microscopically for hyphae, colour of colony to distinguish the strain. The microscopic study of the culture was done before the drug was dispensed.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluconazole
Primary outcome measure	The primary efficacy parameter for clinical response was rated according to an evaluations assessment of the change in signs and symptoms from the baseline. The assessment was rated as "cured" (clearance of all signs and symptoms), "improved" (minimal signs and symptoms with no residual visible candida lesions), unchanged (no change in signs and symptoms), or "deteriorated" (worsening or increasing signs and symptoms). Patients with a clinical evaluation of "cured" or "improved" were considered as a successful outcome of the study.
Secondary outcome measures	Secondary efficacy parameters included the quantification in terms of CFUs of Candida spp. and results of culture from swabs taken at the same sites used at baseline. A mycological cure was defined as a yeast quantification of <10 CFU/ml based on comparison of mycological culture from swabs collected from healthy volunteers. To analyze the data of clinical efficacy statistically, a two-factor repeated measures analysis of variance was used between the treated groups over a period of 44 days. The criterion for significance was set at p<0.05.
Overall study start date	20/07/2008
Completion date	05/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	45
Key inclusion criteria	1. Patients of either sex, aged 18 or above 2. HIV-antibody seropositive or with partial or complete denture and the clinical picture of oropharyngeal candidiasis (OPC), which is characterised by creamy, white, curd like patches, removable erythematous lesions on the oral mucosal surfaces
Key exclusion criteria	1. History of significant hepatic abnormalities or clinical evidence of significant hepatic diseases within 2 months of entering the study 2. Life expectancy of less than 1 month or a clinical condition such that study completion could not be assured 3. History of hypersensitivity to imidazole or azole compound 4. Patients requiring therapy with other antifungal agents, H2-receptor blockers, antacids, rifampicin, phenobarbital, pheytoin, carbamazeme, terfenadine, or astimazole 5. Pregnant or lactating females
Date of first enrolment	20/07/2008
Date of final enrolment	05/09/2008

Locations

Countries of recruitment

India

Study participating centre

Department of Pharmaceutics

Mangalore
575 018
India

Sponsor information

Nitte University (India)
University/education

Paneer
Deralakatte Post
Mangalore
575018
India

Phone	+91 (0)824 2204572
Email	absmids@nitte.ac.in
Website	http://www.nitteuniversity.ac.in/
"ROR"	https://ror.org/029nydt37

Funders

Funder type

University/education

Rajiv Gandhi University of Health Sciences (India)
Government organisation / Local government

Alternative name(s): Rajiv Gandhi University of Health Sciences, Karnataka, RGUHS
Location: India

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/04/2011		Yes	No