Efficacy of Dexpanthenol in Thermic Erythema

Phase 2CompletedNCT00839462

Bayer55 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Erythema

Interventions

Dexpanthenol foam spray, new formulationDRUG

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

Dexpanthenol foam spray, old formulationDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Villeurbanne, France

Outcomes

Primary Outcomes

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

Time frame: 2 min, 5 min, 10 min, 15 min

Secondary Outcomes

Skin temperature

Time frame: 2 min, 5 min, 10 min

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

Time frame: 2 min, 5min, 10 min, 15 min

Evaluation of the foam covering properties after first application

Time frame: 2 min, 5 min, 10 min, 15 min

Incidence of adverse events

Time frame: FPFV - LPLV

Data from ClinicalTrials.gov

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