Efficacy of Dexpanthenol in Thermic Erythema

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00839462

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erythema	Drug: Dexpanthenol foam spray, new formulation Drug: Dexpanthenol foam spray, old formulation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Dexpanthenol foam spray, new formulation 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Active Comparator: Arm 2	Drug: Dexpanthenol foam spray, old formulation 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Dexpanthenol foam spray, new formulation

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

Active Comparator: Arm 2

Drug: Dexpanthenol foam spray, old formulation

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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