NCT00839462

Brief Summary

The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

Same day

First QC Date

February 6, 2009

Last Update Submit

October 18, 2013

Conditions

Erythema

Keywords

Thermal ErythemaDexpanthenolErythemaEfficacy

Outcome Measures

Primary Outcomes (1)

  • Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application

    2 min, 5 min, 10 min, 15 min

Secondary Outcomes (4)

  • Skin temperature

    2 min, 5 min, 10 min

  • Evaluation of the cooling/soothing effect (scores) after first and second application

    2 min, 5min, 10 min, 15 min

  • Evaluation of the foam covering properties after first application

    2 min, 5 min, 10 min, 15 min

  • Incidence of adverse events

    FPFV - LPLV

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Dexpanthenol foam spray, new formulation

Arm 2

ACTIVE COMPARATOR
Drug: Dexpanthenol foam spray, old formulation

Interventions

Dexpanthenol foam spray, new formulationDRUG

2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

Arm 1
Dexpanthenol foam spray, old formulationDRUG

2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • Phototype: I to IV according to Fitzpatrick scale

You may not qualify if:

  • Pregnant or nursing women
  • Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Villeurbanne, 69503, France

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

September 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

FR(1)