Trial Condition(s):
Erythema
Efficacy of Dexpanthenol in thermic erythema
Bayer Identifier:
12039
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.
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
Trial Summary
Enrollment Goal
55
Trial Dates
Phase
2
Could I receive a placebo?
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site VILLEURBANNE, France, 69100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Evaluation of the effect of Bepanthen burn relief foam spray new formula on a thermic erythema. Equivalence trial. Intra-individual design.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second applicationTimeframe: 2 min, 5 min, 10 min, 15 min
Secondary Outcome
- Skin temperatureTimeframe: 2 min, 5 min, 10 min
- Evaluation of the cooling/soothing effect (scores) after first and second applicationTimeframe: 2 min, 5min, 10 min, 15 min
- Evaluation of the foam covering properties after first applicationTimeframe: 2 min, 5 min, 10 min, 15 min
- Incidence of adverse eventsTimeframe: FPFV - LPLV
Additional Information
Copyright © Bayer
Powered by
