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Completed

NCT Number: NCT00839462

Efficacy of Dexpanthenol in Thermic Erythema

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

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Key information

Conditions

Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Villeurbanne, 69503, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexpanthenol foam spray, new formulation

Drug

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

Dexpanthenol foam spray, old formulation

Drug

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

Primary outcomes

  1. 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

  1. Skin temperature

    Time frame: 2 min, 5 min, 10 min

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

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

  3. Evaluation of the foam covering properties after first application

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

  4. Incidence of adverse events

    Time frame: FPFV - LPLV

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 9, 2009
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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