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Comparative Safety Study of New Sinecort Formulation Versus Positive Control

NCT00885937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-06-23

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Dexpanthenol (Sinecort, BAY81-2996)

1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)

DRUG

Positive control, Na-laurylsulfat-solution

50 mikro liter of 0.5 % Sodium-laurylsulfate-solution

DEVICE

Untreated skin under application chamber

Application of treatment chamber as in arm 1 and arm 2 on untreated skin

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00885937 on ClinicalTrials.gov