A Prospective, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy of DermacyteÂ® Cosmetic Cream in Relieving Histamine-induced Pruritus and Wheal & Flare Reaction - Nil

Oxygen Biotherapeutics Inc0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Healthy male or female subjects aged 18â?? 65 years (both inclusive).
•2. Female subjects of childbearing potential must have a negative pregnancy test at screening.
•3. Signed informed consent form.

•1. Subjects with a history of skin irritation or infection in the past 6 months in the intended areas of the histamine skin prick test.
•2. Subjects with any contraindications involving performance of a histamine skin prick test.
•3. Subjects with a medical history of asthma, eczema or other atopic allergy.
•4. Subjects with active skin disease.
•5. Subjects with known sensitivity to paraben.
•6. Pregnant or nursing women.
•7. Use of any investigational drug or therapy within 6 months prior to screening.
•8. Use of any creams, lotions, or other ointments on either arm within 72 hours prior to
•enrollment.
•9. Subjects who have taken any of the following medications:
•Any anti-inflammatory drug (e.g., Ibuprofen) within the last week.
•Any H1 histamine antagonist or other medications with antihistaminic properties (e.g., tricyclic antidepressants) within the last 2 weeks.
•Any topical or systemic steroid product within the 2 months. 10. Subjects with any clinically significant medical conditions which, as determined by the Investigator, would compromise interpretation of the study results.
•11. Any other factor, which may, in the opinion of the Investigator, compromise subject participation or risk subject safety in this study.

发起方

Oxygen Biotherapeutics Inc