Efficacy of Dexpanthenol in Thermic Erythema

Phase 2

Completed

• Conditions: Erythema
• Interventions: Drug: Dexpanthenol foam spray, new formulation; Drug: Dexpanthenol foam spray, old formulation

• Registration Number: NCT00839462
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-18
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

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Exclusion Criteria

• Pregnant or nursing women
• Subjects registered as being in exclusion period in the French Health Minister file of subjects
• Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Dexpanthenol foam spray, new formulation	-
Arm 2	Dexpanthenol foam spray, old formulation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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