check_circleStudy Completed

Healthy

Comparative safety study of new Sinecort formulation versus positive control

Trial purpose

The study is focused to prove a favorable safety profile of the new formulation.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
33
Trial Dates
April 2009 - May 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
proinnovera GmbHMünster, 48155, Germany

Primary Outcome

  • Irritation rate
    date_rangeTime Frame:
    After 21 applications
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Irritation potential
    date_rangeTime Frame:
    After 21 applications
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Single-blind, randomized, controlled, single center trial to evaluate the skin irritation potential of a new topical formulation by means of an occlusive patch test in healthy subjects.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Single Group Assignment
Trial Arms
3