Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
21
Countries
1
Sites
1
facial melasma
Key facts
- Sponsor
- Mesoestetic Pharma Group S.L.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-05-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
facial melasma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10027161 | Melasma | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mesoestetic Pharma Group S.L.
- Sponsor organisation
- Mesoestetic Pharma Group S.L.
- Address
- Calle Tecnologia 25
- City
- Viladecans
- Postcode
- 08840
- Country
- Spain
Scientific contact point
- Organisation
- Mesoestetic Pharma Group S.L.
- Contact name
- Félix Rovira
Public contact point
- Organisation
- Mesoestetic Pharma Group S.L.
- Contact name
- Félix Rovira
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 21 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Hm Torrelodones
Oftalmologia, Avenida Del Castillo De Olivares S/n, 28250, Torrelodones
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-16 | Spain | Acceptable with conditions 2026-05-04
|
2026-05-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-07 | Spain | Acceptable with conditions 2026-05-04
|
2026-05-07 |