Candidiasis
Conditions
Keywords
Candida infections in intertriginous areas
Brief 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.
Interventions
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy and mycological culture | Day 14 | Clinical assesment scores and mycological status of candida (mycological culture) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical examination, AEs | 14 Days | Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration) Percentage of local skin reactions, AEs |
Countries
Germany
Outcome results
None listed