A clinical trial to study the effectiveness of Dermacyte® A clinical trial to study the effectiveness of Dermacyte® Cosmetic Cream in reducing itching, redness and swelling due to Histamine.

Not Applicable

Completed

• Registration Number: CTRI/2012/01/002360
• Lead Sponsor: Oxygen Biotherapeutics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Dermacyte® in reducing acute histamine-induced itch will be assessed as reported by each subject using a standard Visual Analogue scale(VAS Score)Timepoint: 5, 10, 20 and 30 minutes

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable