CandidiasisPhase 2NCT01102387
Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections
A Phase 2 study testing LAS41003, LAS189962 and LAS189961 in people with Candidiasis, run by Almirall, S.A. at 6 sites in Germany.
Trial summary
The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis
- What is being tested?
- LAS41003, LAS189962 and LAS189961
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 6 sitesGermany
- Study dates
- Feb 2010to Jul 2011
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of candida infections in one or more intertriginous areas (trunk), confirmed by positive mycological sample at baseline;
- female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
- written informed consent
Who cannot join
- receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
- patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks;
- evidence of drug or alcohol abuse;
- pregnancy or nursing;
- symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- treatment with any other investigational drug in the four weeks preceding the study;
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- known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol;
- treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. glucocorticosteroids);
- in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Investigational Site #5
Augsburg, 86179
Investigational Site #4
Bad Saarow, 15526
Investigational Site #2
Berlin, 10961
Investigational Site #6
Dülmen, 48249
Investigational Site #1
Hamburg, 20095
Investigational Site #3
Vechta, 49377
About this study
Official title: Phase IIa, Two-centre, Randomized, Double Blind Study to Evaluate the Anti-mycotic and Anti-inflammatory Efficacy of Topical Combinational Product LAS41003 Versus Corresponding Mono-substances in Patients With Candida Infections in Intertriginous Areas at the Trunk
The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.
- Conditions
- Candidiasis
- Being tested
- LAS41003, LAS189962, LAS189961
- Keywords
- Candida infections in intertriginous areas
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41003Drug
Once daily, topically
LAS189962Drug
Once daily, topically
LAS189961Drug
Once daily, topically
| Study group | Role | What they receive |
|---|---|---|
| LAS41003 | Experimental | Not described Receives: Drug: LAS41003 |
| LAS189962 | Active comparator | Not described Receives: Drug: LAS189962 |
| LAS189961 | Active comparator | Not described Receives: Drug: LAS189961 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy and mycological culture
Clinical assesment scores and mycological status of candida (mycological culture)
Measured: Day 14
Secondary outcomes (1)
Physical examination, AEs
Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration)
Percentage of local skin reactions, AEs
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Willers, MD, MBA, Study director, Almirall Hermal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102387
- Sponsor's protocol ID
- H 552 000 - 0920
- Other IDs
- 2009-016627-56, 2009
- Status last verified
- Jan 2011
- First submitted
- 30 Mar 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa, Two-centre, Randomized, Double Blind Study to Evaluate the Anti-mycotic and Anti-inflammatory Efficacy of Topical Combinational Product LAS41003 Versus Corresponding Mono-substances in Patients With Candida Infections in Intertriginous Areas at the Trunk
- ClinicalTrials.gov ID
- NCT01102387
- Acronym / sponsor ID
- H 552 000 - 0920
- Conditions
- Candidiasis
- Keywords
- Candida infections in intertriginous areas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAS41003 | Experimental | Drug: LAS41003 |
| LAS189962 | Active comparator | Drug: LAS189962 |
| LAS189961 | Active comparator | Drug: LAS189961 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of candida infections in one or more intertriginous areas (trunk), confirmed by positive mycological sample at baseline;
- female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
- written informed consent
Key exclusion criteria (9 listed)
- receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
- patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks;
- evidence of drug or alcohol abuse;
- pregnancy or nursing;
- symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAS41003Once daily, topically | Drug | LAS41003 |
| LAS189962Once daily, topically | Drug | LAS189962 |
| LAS189961Once daily, topically | Drug | LAS189961 |
Primary outcome
Clinical efficacy and mycological culture
Time frame: Day 14
Clinical assesment scores and mycological status of candida (mycological culture)
1 secondary outcome
Physical examination, AEs
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
- Almirall Corporate WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Willers, MD, MBA study director
Almirall Hermal GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAS41003, LAS189962 and LAS189961 in people with Candidiasis, run by Almirall, S.A. at 6 sites in Germany.
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 3 inclusion and 9 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 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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 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.
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?
Clinical efficacy and mycological culture (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2012.