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Vulvovaginal Candidiasis (VVC)Phase 2/3NCT03115073

ProF-001_Phase IIa

A Phase 2/3 study testing Candiplus and Clotrimazole in people with Vulvovaginal Candidiasis (VVC), run by ProFem GmbH at 3 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus® with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Vulvovaginal Candidiasis (VVC)
What is being tested?
Candiplus and Clotrimazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
3 sitesAustria
Study dates
4 Apr 2017to 30 Jul 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Premenopausal female patients ≥ 18 years old
  • 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

Who cannot join

  • Known hypersensitivity to any ingredient of the investigational medicinal product
  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Austria3 sites

  • Medical University Innsbruck

    Innsbruck

  • Bezirkskrankenhaus Schwaz

    Schwaz

  • Medical University Vienna

    Vienna

Other trials in Austria

About this study

Official title: A Phase IIa Randomized, Active-controlled, Double-blind, Dose-escalation Study in Patients With Vulvovaginal Candidiasis to Evaluate Dose Response Relationship of Clinical Efficacy, Safety and Tolerability of Topically Administered ProF-001

This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus® with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal cream.

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):

Read more

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.

Being tested
Candiplus, Clotrimazole
Keywords
Vulvovaginal candidiasis, Candiplus, Clotrimazole, Safety, Tolerability, Clinical efficacy
Medical subject headings
Candidiasis, Vulvovaginal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CandiplusDrug

    Administration of Candiplus

  • ClotrimazoleDrug

    Administration of Clotrimazole

Study groups in NCT03115073
Study groupRoleWhat they receive
0,2% CandiplusExperimentalCandiplus® 0.2%
Receives: Drug: Candiplus
0,3% CandiplusExperimentalCandiplus® 0.3%
Receives: Drug: Candiplus
0,4% CandiplusExperimentalCandiplus® 0.4%
Receives: Drug: Candiplus
Clotri monoActive comparatorClotrimazole mono
Receives: Drug: Clotrimazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined outcome measure of: Symptom relief within the first 60 minutes (after application of investigational product or active control) and clinical cure at day 7 (± 3 days).

    As the primary outcome symptom relief within the first 60 minutes will be documented. A reduction of the subjective symptom score ≥ 2 is expected. Furthermore clinical cure at day 7 will be documented. Clinical cure is defined as absence of signs and symptoms of VVC.

    Measured: within 60 minutes after application and at day 7 (± 3 days) after drug application

Secondary outcomes (8)

  1. Number of patients with local adverse events and serious adverse events (SAEs) with causal relationship to study medication

    All local adverse events and serious adverse events with causal relationship to study medication (drug reaction) will be documented in a descriptive manner.

    Measured: overall study period (max. 65 days)

  2. Symptom relief within the first 60 minutes (after application of investigational product or active control, reduction of the subjective symptom score ≥ 2)

    Symptom relief within the first 60 minutes will be documented. A reduction of the subjective symptom score ≥ 2 is expected.

    Measured: within 60 minutes after drug application

  3. Clinical cure (absence of signs and symptoms of VVC) at the TOC visit (=day 7/ accepted time window ±3days)

    Clinical cure at day 7 will be documented. Clinical cure is defined as absence of signs and symptoms of VVC.

    Measured: day 7 ±3 days after drug application

  4. Mycological outcome: Vaginal swab culture negative for growth of Candida albicans and/or Candida species at the TOC visit (day 7 / ±3days)

    A vaginal swab culture will be taken on day 7 / ±3days. The test result is expected to be negative for growth of Candida albicans and/or Candida species.visit (day 7 / ±3days)

    Measured: day 7 ±3 days after drug application

  5. Responder outcome: absence of signs and symptoms plus vaginal swab culture negative for growth of Candida albicans and/or Candida species at the TOC visit (day 7 / ±3days)

    Presence or absence of signs and symptoms will be documented. Vaginal swab culture is expected to be negative for growth of Candida albicans and/or Candida species at the TOC visit.

    Measured: day 7 ±3 days after drug application

  6. Time to improvement of symptoms after first intervention

    The time to improvement of symptoms after the first intervention will be documented.

    Measured: overall study period (max. 65 days)

  7. Time to termination of clinical symptoms

    The time to termination of clinical symptoms will be documented.

    Measured: overall study period (max. 65 days)

  8. Clinical relapse of VVC during follow-up period

    Every clinical relapse of VVC during the follow-up period will be documented.

    Measured: follow-up period (from day 8 to day 60)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start4 Apr 2017
  3. Primary completion30 Jul 2018
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115073
Sponsor's protocol ID
ProF-001_Phase IIa
Status last verified
Sep 2017
First submitted
13 Mar 2017
Last updated
14 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Achkar JM, Fries BC. Candida infections of the genitourinary tract. Clin Microbiol Rev. 2010 Apr;23(2):253-73. doi: 10.1128/CMR.00076-09.

    PubMed 20375352

  • Alem MA, Douglas LJ. Prostaglandin production during growth of Candida albicans biofilms. J Med Microbiol. 2005 Nov;54(Pt 11):1001-1005. doi: 10.1099/jmm.0.46172-0.

    PubMed 16192429

  • 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.

    PubMed 18976735

  • 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.

    PubMed 25770305

  • Cannom RR, French SW, Johnston D, Edwards JE Jr, Filler SG. Candida albicans stimulates local expression of leukocyte adhesion molecules and cytokines in vivo. J Infect Dis. 2002 Aug 1;186(3):389-96. doi: 10.1086/341660. Epub 2002 Jul 11.

    PubMed 12134235

  • 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.

    PubMed 8698486

  • 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.

    PubMed 9478896

  • Haynes K. Virulence in Candida species. Trends Microbiol. 2001 Dec;9(12):591-6. doi: 10.1016/s0966-842x(01)02237-5.

    PubMed 11728872

  • King RD, Lee JC, Morris AL. Adherence of Candida albicans and other Candida species to mucosal epithelial cells. Infect Immun. 1980 Feb;27(2):667-74. doi: 10.1128/iai.27.2.667-674.1980.

    PubMed 6991423

  • Klotz SA. Fungal adherence to the vascular compartment: a critical step in the pathogenesis of disseminated candidiasis. Clin Infect Dis. 1992 Jan;14(1):340-7. doi: 10.1093/clinids/14.1.340.

    PubMed 1571448

  • Kolachala VL, Bajaj R, Wang L, Yan Y, Ritzenthaler JD, Gewirtz AT, Roman J, Merlin D, Sitaraman SV. Epithelial-derived fibronectin expression, signaling, and function in intestinal inflammation. J Biol Chem. 2007 Nov 9;282(45):32965-73. doi: 10.1074/jbc.M704388200. Epub 2007 Sep 13.

    PubMed 17855340

  • 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.

    PubMed 23974350

  • 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.

    PubMed 15078430

  • 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.

    PubMed 25935553

  • 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.

    PubMed 15339267

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Candiplus and Clotrimazole in people with Vulvovaginal Candidiasis (VVC), run by ProFem GmbH at 3 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined outcome measure of: Symptom relief within the first 60 minutes (after application of investigational product or active control) and clinical cure at day 7 (± 3 days). (time frame: within 60 minutes after application and at day 7 (± 3 days) after drug application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115073, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.

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