Study of diclofenac skin reservoir formation and emptying after Voltaren Emulgel 2.32% application in healthy participants

2025-524764-38-00 Protocol 400314 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 26 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol 400314

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 12
Countries 1
Sites 1

For the local, symptomatic treatment of pain in acute bruises, strains, or sprains due to blunt trauma, e.g., sports and accident injuries

Key facts

Sponsor
Haleon CH SARL
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
Trial duration
26 May 2026 → ongoing
Decision date (initial)
2026-04-09
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

For the local, symptomatic treatment of pain in acute bruises, strains, or sprains due to blunt trauma, e.g., sports and accident injuries

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Haleon CH SARL

Sponsor organisation
Haleon CH SARL
Address
Case Postale 1279
City
Nyon 1
Postcode
1260
Country
Switzerland

Scientific contact point

Organisation
Haleon CH SARL
Contact name
Nora Schneider

Public contact point

Organisation
Haleon CH SARL
Contact name
Nora Schneider

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ongoing, recruiting 12 1
Rest of world 0

Investigational sites

Germany

1 site · Ongoing, recruiting
SGS proderm GmbH
SGS proderm Site, Kiebitzweg 2, 22869, Schenefeld

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2026-05-26 2026-05-26

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-04 Germany Acceptable
2026-04-01
2026-04-09