Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
33
Countries
1
Sites
1
Test of vasocontriction properties for classification of topical steroid potency
Key facts
- Sponsor
- Cassiopea S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 26 Feb 2024 → 10 Apr 2024
- Decision date (initial)
- 2024-01-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Test of vasocontriction properties for classification of topical steroid potency
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10047140 | Vasoconstriction peripheral | 10047065 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cassiopea S.p.A.
- Sponsor organisation
- Cassiopea S.p.A.
- Address
- Via Cristoforo Colombo 1
- City
- Lainate
- Postcode
- 20045
- Country
- Italy
Scientific contact point
- Organisation
- Cassiopea S.p.A.
- Contact name
- Clinical Operation Manager
Public contact point
- Organisation
- Cassiopea S.p.A.
- Contact name
- Clinical Operation Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 33 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-02-26 | 2024-04-10 | 2024-02-28 | 2024-04-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-01 | Germany | Acceptable 2024-01-26
|
2024-01-29 |