Double-blind, randomised clinical study comparing efficacy and safety of Mecloderm® Ointment (Test) vs. Lotricomb® Ointment (Reference) vs. Vehicle in patients with moderate to severely inflamed candidiasis of the skin

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501415-14-00

Acronym

21-01/ClotriBet-S

Enrollment

552

Registered

2024-05-15

Start date

2022-03-08

Completion date

Unknown

Last updated

2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate to severely inflamed candidiasis of the skin

Brief summary

Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).

Detailed description

Change of the sum score of clinical parameters between baseline and follow-up visits, and between main examination (EOT) and final examination, Number (percentage) of patients with mycological success (negative mycological cultivation and/or negative microscopical result) at visit 3 (EOT) and at the final visit (visit 4), Evaluation of therapeutic success at visit 2 and EOT by the investigator and by the patient, Evaluation of overall therapeutic success by the investigator at the final examination, Number (percentage) of patients with clinical relapse/re-infection at the final examination visit

Interventions

DRUGLOTRICOMB® Salbe

DRUG0

DRUG64 mg/g + 10 mg/g

DRUGSalbe

DRUGMecloderm Ointment

DRUGVehicle to Mecloderm Ointment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).	—

Secondary

Measure	Time frame
Change of the sum score of clinical parameters between baseline and follow-up visits, and between main examination (EOT) and final examination, Number (percentage) of patients with mycological success (negative mycological cultivation and/or negative microscopical result) at visit 3 (EOT) and at the final visit (visit 4), Evaluation of therapeutic success at visit 2 and EOT by the investigator and by the patient, Evaluation of overall therapeutic success by the investigator at the final examination, Number (percentage) of patients with clinical relapse/re-infection at the final examination visit	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026