Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea Pedis

NCT01096472

Tinea Pedis

COMPLETED PHASE2

Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

NCT00443898

Onychomycosis

COMPLETED PHASE3

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

NCT02812771

Onychomycosis

COMPLETED PHASE4

Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

NCT04813822

Acute Vulvovaginal Candidiasis

UNKNOWN PHASE2

Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

NCT05660382

Otomycosis

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Candidiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LAS41003

Group Type EXPERIMENTAL

LAS41003

Intervention Type DRUG

Once daily, topically

LAS189962

Group Type ACTIVE_COMPARATOR

LAS189962

Intervention Type DRUG

Once daily, topically

LAS189961

Group Type ACTIVE_COMPARATOR

LAS189961

Intervention Type DRUG

Once daily, topically

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LAS41003

Once daily, topically

Intervention Type DRUG

LAS189962

Once daily, topically

Intervention Type DRUG

LAS189961

Once daily, topically

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No