Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
552
Countries
1
Sites
5
moderate to severely inflamed candidiasis of the skin
Key facts
- Sponsor
- Dermapharm AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 18 Oct 2021 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514364-54-00
- EudraCT number
- 2018-003073-10
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
moderate to severely inflamed candidiasis of the skin
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007159 | Candidiasis of skin and nails | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dermapharm AG
- Sponsor organisation
- Dermapharm AG
- Address
- Lil-Dagover-Ring 7, Geiselgasteig Geiselgasteig
- City
- Gruenwald
- Postcode
- 82031
- Country
- Germany
Scientific contact point
- Organisation
- Dermapharm AG
- Contact name
- Clinical Research Department
Public contact point
- Organisation
- Dermapharm AG
- Contact name
- Clinical Research Department
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 552 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Praxis Dr. med. Friederike Greven
NA, Pfarrstraße 47, 30459, Hannover
Hautarztpraxis Dr. Offers und Dr. Adamini
Hautarztpraxis Dr. Offers und Dr. Adamini, Gravenhorster Str. 5, 49477, Ibbenbüren
Dr. med. Stefan Fiedler
NA, Schurzelter Strasse 571, 52074, Aachen
Gemeinschaftspraxis Weber & Crainic
Gemeinschaftspraxis R. Weber & A. Crainic, Böheimstrasse 8, 86153, Augsburg
Studienzentrum Dr. med. Beate Schwarz Dermatologie und Allergologie
Studienzentrum Dr. Beate Schwarz Dermatologie und Allergologie, Bismarckstrasse 49, 89129, Langenau
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2021-10-18 | 2021-10-18 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-31 | Germany | Acceptable 2024-08-12
|
2024-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-05 | Germany | Acceptable | 2024-12-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-05 | Germany | Acceptable 2025-07-09
|
2025-07-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-30 | Germany | Acceptable | 2025-08-15 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-19 | Germany | Acceptable | 2025-12-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-20 | Germany | Acceptable | 2026-01-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-09 | Germany | Acceptable 2026-04-02
|
2026-04-08 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-11 | Germany | Acceptable 2026-04-02
|
2026-05-11 |