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Efficacy of Dexpanthenol in Thermic Erythema

Primary Purpose

Erythema

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Dexpanthenol foam spray, new formulation

Dexpanthenol foam spray, old formulation

About this trial

This is an interventional treatment trial for Erythema focused on measuring Thermal Erythema, Dexpanthenol, Erythema, Efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Skin temperature

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

Evaluation of the foam covering properties after first application

Incidence of adverse events

Full Information

NCT ID

NCT00839462

First Posted

February 6, 2009

Last Updated

October 18, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00839462

Brief Title

Efficacy of Dexpanthenol in Thermic Erythema

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erythema

Keywords

Thermal Erythema, Dexpanthenol, Erythema, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Dexpanthenol foam spray, new formulation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexpanthenol foam spray, old formulation

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Skin temperature

Time Frame

2 min, 5 min, 10 min

Title

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

Time Frame

2 min, 5min, 10 min, 15 min

Title

Evaluation of the foam covering properties after first application

Time Frame

2 min, 5 min, 10 min, 15 min

Title

Incidence of adverse events

Time Frame

FPFV - LPLV

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Villeurbanne

ZIP/Postal Code

69503

Country

France

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Dexpanthenol in Thermic Erythema

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