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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002360
Enrollment
30
Registered
2012-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dermacyte® Cosmetic Cream: The intervention agent is Dermacyte® cosmetic cream, based on a third- generation, proprietary perfluorocarbon (PFC) therapeutic oxygen carrier product form

Sponsors

Oxygen Biotherapeutics Inc
Lead Sponsor
Max Neeman International
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDr Shariq Anwar

Max Neeman International

atulg@neemanasia.com91-9717287654

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026