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Efficacy of Dexpanthenol in Thermic Erythema

NCT ID: NCT00839462

Last Updated: 2013-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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Conditions

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Erythema

Keywords

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Thermal Erythema Dexpanthenol Erythema Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Dexpanthenol foam spray, new formulation

Intervention Type DRUG

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

Arm 2

Group Type ACTIVE_COMPARATOR

Dexpanthenol foam spray, old formulation

Intervention Type DRUG

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

Interventions

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Dexpanthenol foam spray, new formulation

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

Intervention Type DRUG

Dexpanthenol foam spray, old formulation

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Villeurbanne, , France

Site Status

Countries

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France

Other Identifiers

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12039

Identifier Type: -

Identifier Source: org_study_id