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Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

Primary Purpose

Vaginal Candidiasis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ketoconazole
Terconazole
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • The selected patients had - vaginal candidiasis ,diagnosed by history of pruritus in addition to the characteristic discharge of vaginal candidiasis by vaginal examination

Exclusion Criteria:

  • Women on other line of treatment as antimicrobial treatment either topical or systemic drugs within one month prior to the first clinical examination
  • Known hypersensitivity for ketoconazole

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ketoconazole gel

    terconazole cream

    Arm Description

    use of Ketoconazole in situ gel for treatment of vaginal candidiasis

    use of terconazole 0.8 cream for treatment of vaginal candidiasis

    Outcomes

    Primary Outcome Measures

    measure effect of ketoconazole gel in treatment of vaginal candidiasis
    efficacy of ketoconazole gel by taking a vaginal swab for microbiological examination before treatment and another swab one week after treatment
    improvement of patient complaint
    improvement of vaginal symptoms and discharge

    Secondary Outcome Measures

    rate of relapse
    recurrence of symptoms and discharge (patient complaint )

    Full Information

    First Posted
    March 4, 2018
    Last Updated
    March 15, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03473418
    Brief Title
    Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis
    Official Title
    Ketoconazole In Situ Gel Versus Terconazole Cream for Treatment of Vaginal Candidiasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    October 1, 2018 (Anticipated)
    Study Completion Date
    April 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vaginal Candidiasis is an infection caused by a yeast normally lives inside the body . Sometimes Candida can multiply and cause an infection if the environment inside the vagina changes in a way that encourages its growth. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Risk factor use of intra uterine devices , pregnancy ,use hormonal contraceptives ,have diabetes , immune compromised taken antibiotics Diagnosis cause itching or soreness Pain during sexual intercourse Pain or discomfort when urinating and abnormal vaginal discharge Although most vaginal candidiasis is mild, some women can develop severe infections involving redness, swelling, and cracks in the wall of the vagina
    Detailed Description
    terconazole- Terconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal activity of Terconazole. Mammalian cell demethylation is less sensitive to Terconazole inhibition Terconazole exhibits antifungal activity in vitro against Candida albicans and other Candida species. The MIC (maximum insufflation capacity values of Terconazole against most Lactobacillus spp. typically found in the human vagina were ≥128 mcg/mL; therefore these beneficial bacteria are not affected by drug treatment. Terconazole Vaginal cream, 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Ketoconazole is a broad- spectrum antimycotic agent that can be used orally or topically in the treatment vulvovaginal candidiasis and other fungal infections Candida is the second most common cause of vaginal infections. Candida albicans is responsible for 80 to 92% of episodes of vulvovaginal candidiasis . The rest are due to non-albicans Candida species, the most common of which are C. glabrata and C. tropicalis. Sporadic attacks of vulvovaginal candidiasis usually occur without an identifiable precipitating factor. The risk of vulvovaginal candidiasis may be higher in women with uncontrolled diabetes, who use oral contraceptives containing high levels of estrogen or taking antibiotics. In situ gelling systems refer to polymer solutions which can be administered as liquid, and undergo a phase transition to semisolid gel upon exposure to physiological environments. Stimuli- sensitive hydrogels are those hydrogels, which undergo reversible volume phase - transition or sol - gel phase transition in response to external physical stimuli such as (temperature) or chemical stimuli as (ions).The most commonly used thermoreversible gels are those prepared from the pluronic block copolymers . The principle advantage of in situ forming gels is the possibility of administering accurate and reproducible quantities, in contrast to already gelled formulation . Several in situ gel forming systems have been developed to prolong the residence time of a drug and improve the bioavailability and control the drug release by changing the gel structure in response to environmental stimuli . These systems provide simplicity and safety in in vivo situations . They are handled in the liquid state before their delivery, which is likely to facilitate their use and to increase the surface of contact with the mucous membrane. The flow properties of semi-solid vaginal dosage forms might be of use to predict the spreading and coating of the formulations over the vaginal epithelia . When the preparation is given as liquid, this will give better spreading and coating of vaginal surfaces than the gelled preparations, which have not the ability to cover all the surfaces and cannot reach to epithelial folds of the vagina. So, this study aimed to formulate ketoconazole in a new vaginal mucoadhesive form "In situ gel" and it is designed to achieve the following objectives: Formulation and evaluation of in situ-forming vaginal gels of ketoconazole. Clinical assessment of the prepared vaginal ketoconazole in situ gels on women suffering from vaginal candidiasis. Materials and Methods: Preparation of ketoconazole vaginal in situ gel Different concentrations of pluronic F-127 will be used in the preparation of the in situ forming gels. Medicated in situ forming gels will be prepared on a weight basis using The Modified Cold Method .Vaginal preparations will be prepared in citro-phosphate buffer pH (power of hydrogen) 4.5. Characterization of ketoconazole vaginal in situ gel Gelation temperature (Tgel) measurement Ten milliliters of cold pluronic solution and a magnetic bar will be put into a beaker (25 ml) that will be placed in a low temperature water bath at room temperature. A thermometer will be immersed in the sample solution. The solution will be heated at constant rate with continuous stirring at a rate of 200 rpm. The temperature at which the magnetic bar stopped to move due to gelation will be reported as the gelation temperature (Tgel) (11). Rheological studies The viscosity of each formula will be determined using a Brookfield DV (diluted volume )-III Ultra viscometer (RV model). The spindles used will be 60 for liquids and 95 for gels. Measurements will be carried out at spindle speed of 15 rpm. Viscosity will be measured at different temperatures 4ºC (celsius degree ), 25ºC, and 37ºC. In vitro release of Ketoconazole from in situ gelling formulations In vitro release from in situ gelling formulae will be studied using a standard semi-permeable cellophane membrane. The membrane will be soaked in the release medium (simulated vaginal fluid 'SVF') overnight prior to its use. One gram solution of formulations will be weighed over the membrane in the dialytic tube. The prepared tube will be suspended in 100 ml freshly prepared SVF (simulated vaginal fluid ). The system will be placed into a constant temperature shaker water bath previously adjusted to 37 + 0.2 ºC and 50 rpm. Aliquots (1 ml) will be withdrawn from the release medium at each sampling time for up to 2 hours and the amount of the drug released will be calculated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Candidiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketoconazole gel
    Arm Type
    Experimental
    Arm Description
    use of Ketoconazole in situ gel for treatment of vaginal candidiasis
    Arm Title
    terconazole cream
    Arm Type
    Active Comparator
    Arm Description
    use of terconazole 0.8 cream for treatment of vaginal candidiasis
    Intervention Type
    Drug
    Intervention Name(s)
    Ketoconazole
    Intervention Description
    Ketoconazole as a topical vaginal gel
    Intervention Type
    Drug
    Intervention Name(s)
    Terconazole
    Intervention Description
    Terconazole 80 mg as a topical vaginal cream
    Primary Outcome Measure Information:
    Title
    measure effect of ketoconazole gel in treatment of vaginal candidiasis
    Description
    efficacy of ketoconazole gel by taking a vaginal swab for microbiological examination before treatment and another swab one week after treatment
    Time Frame
    ketoconazole used once daily for 3 days
    Title
    improvement of patient complaint
    Description
    improvement of vaginal symptoms and discharge
    Time Frame
    one week
    Secondary Outcome Measure Information:
    Title
    rate of relapse
    Description
    recurrence of symptoms and discharge (patient complaint )
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The selected patients had - vaginal candidiasis ,diagnosed by history of pruritus in addition to the characteristic discharge of vaginal candidiasis by vaginal examination Exclusion Criteria: Women on other line of treatment as antimicrobial treatment either topical or systemic drugs within one month prior to the first clinical examination Known hypersensitivity for ketoconazole

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    10824446
    Citation
    Garcia Figueroa RG, Sauceda L, Ramirez Palacios D, Cruz Talonia F, Romero Cabello R. [Effectiveness and safety of ciclopirox olamine 1% vaginal cream versus terconazole 0.8% vaginal cream in the treatment of genital candidiasis]. Ginecol Obstet Mex. 2000 Apr;68:154-9. Spanish.
    Results Reference
    background

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    Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

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