Skin dryness and itching Skin and Connective Tissue Diseases
Conditions
Interventions
Bioakè cream and placebo were applied on the volar surface of each participant (2 mg/cm2) under controlled conditions by the experimenter and another area of the forearm was left untreated and acted a
Sponsors
Ekuberg Pharma
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Registered with the National Health Service (NHS) 3. Aged between 18 and 60 years old 4. Caucasian ethnicity 5. Subjects with sensitive, dry and reactive skin 6. Subject with positive reaction to stinging test with capsaicin (10% hydroalcoholic capsaicin 3.6 x 10-3%) 7. Subjects certifying the truthfulness of the personal data disclosed to the investigator 8. Subjects able to understand the language used in the investigation center and the information given by the investigator, as well as able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 9. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least 1 month without any changes expected or planned during the study 10. Commitment not to change one's daily routine and lifestyle 11. Subjects aware of the test procedure and have signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Acute or chronic diseases capable of interfering with the outcome of the study or that are considered dangerous for the subject or incompatible with the requirements of the study 2. Taking part or planning to participate in other clinical trials and participated in a similar study without respecting an adequate washout period 3. Undergoing drug therapy considered by the investigator to be reactions incompatible with the requirements of the study 4. Clinical history of irritative to cosmetics, drugs, patches or cosmetic devices 5. Breastfeeding or pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Transepidermal water loss measured using the internationally recognized TEWAMETER® method. The used instrument is a Tewameter 300® (Courage+Khazaka, electronic GmbH) at baseline (T0) and 4 hours after the single product application. 2. Skin hydration measured using a CORNEOMETER® at baseline (T0) and 4 hours after the single product application. 3. Itching relief: after a capsaicin solution was applied to the skin of both nasolabial fold sides of each volunteer, the experimenter scores the intensity of the perceived discomfort immediately after and 1, 2, 3, 4, 5, 7, 10 minutes after the first product application. At each monitored time the experimenter registers, with the collaboration of the subject, the intensity of the perceived discomfort sensations (stinging/itching sensation), according to the scores: 1 = no reaction; 2 = mild reaction; 3 = moderate reaction; 4 = severe reaction. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Italy
Contacts
Public ContactDavide Carati
Outcome results
None listed