ISRCTN16954825
Completed
未知
Improvement in skin barrier function and itch relief on dry skin: a short-term, placebo-controlled study of the efficacy of Bioakè cream
Ekuberg Pharma0 sites20 target enrollmentNovember 9, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Skin dryness and itching
- Sponsor
- Ekuberg Pharma
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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