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Clinical Trials/ISRCTN16954825
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.

Registry
who.int
Start Date
November 9, 2023
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Ekuberg Pharma

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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