Erythema
Conditions
Keywords
Thermal Erythema, Dexpanthenol, Erythema, Efficacy
Brief summary
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.
Interventions
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed