Clinical trial • Dermatology
Mecloderm® Cream (Test) for Cutaneous candidiasis | Candidiasis of skin and nails
Clinical trial of Mecloderm® Cream (Test) for Cutaneous candidiasis | Candidiasis of skin and nails.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Cutaneous candidiasis | Candidiasis of skin and nails
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-07-2024
- First CTIS Authorization Date
- 14-08-2024
Trial design
Randomised, mecloderm® cream (test) vs. lotricomb® cream (reference) vs. vehicle (no doses or schedules specified)-controlled trial across 5 sites in Germany.
- Randomised
- Yes
- Comparator
- Mecloderm® Cream (Test) vs. Lotricomb® Cream (Reference) vs. Vehicle (no doses or schedules specified)
- Target Sample Size
- 552
Eligibility
Recruits 552 isVulnerablePopulationSelected: true — no further details on consent/assent provided in the record.
- Vulnerable Population
- isVulnerablePopulationSelected: true — no further details on consent/assent provided in the record
Recruitment
- Planned Sample Size
- 552
- Recruitment Window Months
- 62
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 552
Germany
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 642
- Number Of Sites
- 5
- Number Of Participants
- 552
Sites
- Site Name
- Dr. med. Stefan Fiedler
- Principal Investigator Name
- Stefan Fiedler
- Principal Investigator Email
- praxis.fiedler.gyn@web.de
- Contact Person Name
- Stefan Fiedler
- Contact Person Email
- praxis.fiedler.gyn@web.de
- Site Name
- Praxis Dr. med. Friederike Greven
- Principal Investigator Name
- Friederike Greven
- Principal Investigator Email
- info@gyn-praxis-pfarrstr.de
- Contact Person Name
- Friederike Greven
- Contact Person Email
- info@gyn-praxis-pfarrstr.de
- Site Name
- Hautarztpraxis Dr. Offers und Dr. Adamini
- Department Name
- Hautarztpraxis Dr. Offers und Dr. Adamini
- Principal Investigator Name
- Michael Offers
- Principal Investigator Email
- adamini.offers@web.de
- Contact Person Name
- Michael Offers
- Contact Person Email
- adamini.offers@web.de
- Site Name
- Studienzentrum Dr. med. Beate Schwarz Dermatologie und Allergologie
- Department Name
- Studienzentrum Dr. Beate Schwarz Dermatologie und Allergologie
- Principal Investigator Name
- Beate Schwarz
- Principal Investigator Email
- studie@hautarzt-langenau.de
- Contact Person Name
- Beate Schwarz
- Contact Person Email
- studie@hautarzt-langenau.de
- Site Name
- Gemeinschaftspraxis Weber & Crainic
- Department Name
- Gemeinschaftspraxis R. Weber & A. Crainic
- Principal Investigator Name
- Ridwan Weber
- Principal Investigator Email
- info@wedermic.de
- Contact Person Name
- Ridwan Weber
- Contact Person Email
- info@wedermic.de
Sponsor
Primary sponsor
- Full Name
- Dermapharm AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Mecloderm® Cream (Test)
- Modality
- Small molecule
- Routes Of Administration
- Topical (cream)
- Route
- Topical
- Investigational Product Name
- Lotricomb® Cream (Reference)
- Modality
- Small molecule
- Routes Of Administration
- Topical (cream)
- Route
- Topical
- Investigational Product Name
- Vehicle
- Modality
- Other
- Routes Of Administration
- Topical (cream)
- Route
- Topical
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