Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
84 participants
INTERVENTIONAL
2017-04-04
2018-07-30
Brief Summary
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Patients with acute episode of vulvovaginal candidiasis (VVC) will be randomized to receive a daily dose of either 5 ml (intravaginal) of Candiplus® at three different doses for the first 3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1% clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the following scheme (with each application 2 cm of cream will be applied to the vulvar region):
Cohort 1: Candiplus® 0.2% versus clotrimazole mono Cohort 2: Candiplus® 0.3% versus clotrimazole mono Cohort 3: Candiplus® 0.4% versus clotrimazole mono Randomization into the cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will be randomized first in cohort 1 and finally in cohort 3.
The proposed study is - after a pilot study to assess critical pharmacokinetic data - the second study within a clinical trial program with the objective to develop a new combination therapy for the treatment of vulvovaginal candidiasis.
The new combination consists of two registered drug substances.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0,2% Candiplus
Candiplus® 0.2%
Candiplus
Administration of Candiplus
0,3% Candiplus
Candiplus® 0.3%
Candiplus
Administration of Candiplus
0,4% Candiplus
Candiplus® 0.4%
Candiplus
Administration of Candiplus
Clotri mono
Clotrimazole mono
Clotrimazole
Administration of Clotrimazole
Interventions
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Candiplus
Administration of Candiplus
Clotrimazole
Administration of Clotrimazole
Eligibility Criteria
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Inclusion Criteria
* Patients suffering from an acute episode of vulvovaginal candidiasis, characterized by:
* Positive vaginal smear (native, KOH) for budding yeasts and/or fungal (pseudo-) hyphae, normal or intermediate flora (G I and G II)
* Positive clinical symptoms (itching, burning, irritation, edema, erythema, excoriations), with a subjective symptom score of at least 3 (0=absent, 1=mild, 2=moderate, and 3=severe), with score being at least moderate for at least 1 subjective symptom and itching being present, and a total sign and symptom score of at least 4
* Readiness for sexual abstinence from start of treatment until test of cure (TOC) - visit
* Sufficient knowledge of German language to understand trial instructions and rating scales, and ability to comply with treatment
* Written informed consent prior to enrolment
Exclusion Criteria
* Pregnancy or breast feeding at time of screening
* Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment
* Acute cystitis
* Patients with clinical signs of other infectious causes of vulvovaginitis: bacterial vaginosis (GIII), trichomonas vaginalis, herpes simplex genitalis
* Treatment with antimycotics (systemic or vaginal) within 7 days of randomization
* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
* Patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis)
* Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. Lichen sclerosus, neuropathic pain)
* Subjects who will be under treatment or surgery for gynecological pathologies during the study period, i.e, cervical intraepithelial neoplasia, cervical carcinoma, other neoplasms
* Known alcohol, drug or medication abuse
* Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient's compliance (eg. known immune deficiency syndrome with clinical relevance at time of screening)
* Participation in another interventional clinical trial within the last 30 days
* Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
18 Years
FEMALE
No
Sponsors
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ProFem GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Herbert Kiss, Ao.Univ.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University Innsbruck
Innsbruck, , Austria
Bezirkskrankenhaus Schwaz
Schwaz, , Austria
Medical University Vienna
Vienna, , Austria
Countries
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References
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Donders G, Bellen G, Byttebier G, Verguts L, Hinoul P, Walckiers R, Stalpaert M, Vereecken A, Van Eldere J. Individualized decreasing-dose maintenance fluconazole regimen for recurrent vulvovaginal candidiasis (ReCiDiF trial). Am J Obstet Gynecol. 2008 Dec;199(6):613.e1-9. doi: 10.1016/j.ajog.2008.06.029. Epub 2008 Oct 30.
Dovnik A, Golle A, Novak D, Arko D, Takac I. Treatment of vulvovaginal candidiasis: a review of the literature. Acta Dermatovenerol Alp Pannonica Adriat. 2015;24(1):5-7. doi: 10.15570/actaapa.2015.2.
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Filler SG, Pfunder AS, Spellberg BJ, Spellberg JP, Edwards JE Jr. Candida albicans stimulates cytokine production and leukocyte adhesion molecule expression by endothelial cells. Infect Immun. 1996 Jul;64(7):2609-17. doi: 10.1128/iai.64.7.2609-2617.1996.
Gale CA, Bendel CM, McClellan M, Hauser M, Becker JM, Berman J, Hostetter MK. Linkage of adhesion, filamentous growth, and virulence in Candida albicans to a single gene, INT1. Science. 1998 Feb 27;279(5355):1355-8. doi: 10.1126/science.279.5355.1355.
Haynes K. Virulence in Candida species. Trends Microbiol. 2001 Dec;9(12):591-6. doi: 10.1016/s0966-842x(01)02237-5.
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Mathe L, Van Dijck P. Recent insights into Candida albicans biofilm resistance mechanisms. Curr Genet. 2013 Nov;59(4):251-64. doi: 10.1007/s00294-013-0400-3. Epub 2013 Aug 25.
Mendling W, Krauss C, Fladung B. A clinical multicenter study comparing efficacy and tolerability of topical combination therapy with clotrimazole (Canesten, two formats) with oral single dose fluconazole (Diflucan) in vulvovaginal mycoses. Mycoses. 2004 Apr;47(3-4):136-42. doi: 10.1111/j.1439-0507.2004.00970.x.
Muzny CA, Schwebke JR. Biofilms: An Underappreciated Mechanism of Treatment Failure and Recurrence in Vaginal Infections. Clin Infect Dis. 2015 Aug 15;61(4):601-6. doi: 10.1093/cid/civ353. Epub 2015 May 1.
Naglik J, Albrecht A, Bader O, Hube B. Candida albicans proteinases and host/pathogen interactions. Cell Microbiol. 2004 Oct;6(10):915-26. doi: 10.1111/j.1462-5822.2004.00439.x.
Noverr MC, Phare SM, Toews GB, Coffey MJ, Huffnagle GB. Pathogenic yeasts Cryptococcus neoformans and Candida albicans produce immunomodulatory prostaglandins. Infect Immun. 2001 May;69(5):2957-63. doi: 10.1128/IAI.69.5.2957-2963.2001.
Noverr MC, Huffnagle GB. Regulation of Candida albicans morphogenesis by fatty acid metabolites. Infect Immun. 2004 Nov;72(11):6206-10. doi: 10.1128/IAI.72.11.6206-6210.2004.
Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991 Feb;29(2):297-301. doi: 10.1128/jcm.29.2.297-301.1991.
Ray WA, Varas-Lorenzo C, Chung CP, Castellsague J, Murray KT, Stein CM, Daugherty JR, Arbogast PG, Garcia-Rodriguez LA. Cardiovascular risks of nonsteroidal antiinflammatory drugs in patients after hospitalization for serious coronary heart disease. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):155-63. doi: 10.1161/CIRCOUTCOMES.108.805689. Epub 2009 May 5.
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Related Links
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Lisa A. Bero, February 15, 2005, Expert Committee on Selection and Use of Essential Medicines, Review of Application of Clotrimazole for topical or intravaginal use in vulvovaginal candidiasis.
FDA draft Guidance for Industry Vulvovaginal Candidiasis -Developing Drugs for Treatment, 2016.
Newcombe, R.G. "Interval estimation for the difference between independent proportions: comparison of eleven methods" Statistics in Medicine 17(1988) pp. 873-890
Santoni G, Gismondi A, Liu JH, et al. Candida albicans expresses a fibronectin receptor antigenically related to a5b1 integrin. Microbiology. 1994 Nov;140 ( Pt 11):2971-9.
Sobel JD, Wiesenfeld HC, Martens M, et al. Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. N Engl J Med. 2004b Aug 26;351(9):876-83.
Voltarol Suppositories 12.5 mg, 25 mg, 50 mg, 100 mg, UK SmPC 2013
Other Identifiers
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ProF-001_Phase IIa
Identifier Type: -
Identifier Source: org_study_id
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