RecruitingPhase 2ACTRN12611000920998

A study of Abalone Haemocyanin for cold sores

A Randomised, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate Safety and Efficacy of Topical Abalone Haemocyanin Once Daily for the Treatment of Herpes Labialis in Immunocompetent Patients


Sponsor

Marine Biotechnology Australia Pty Limited

Enrollment

210 participants

Start Date

Aug 25, 2011

Study Type

Interventional

Conditions

Summary

Herpes labialis (cold sores) caused by herpes simplex virus type 1 (HSV-1) is a common condition affecting millions of people worldwide. The pathogenesis of the disease suggests that brief and early immunogenic therapy may be a logical approach. Abalone Haemocyanin (AH) derived from live abalone. The literature and clinical data generated by the sponsor of this study, indicate that AH has the potential for prophylaxis and therapeutic treatment of all stages of oral herpes. The proposed study is to look at the safety and effectiveness of topical AH for 5 days compared with placebo.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • Male or female with history of recurrent cold sores and have experienced at least three episodes in the previous 12 months.

Exclusion Criteria1

  • Any significant unstable medical condition, allergic reaction or sensitivity to haemocyanin from any source, or a food allergy to seafood or shellfish.

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Interventions

Abalone Haemocyanin (AH) 50mg applied topically once daily for 5 days within 6 hours of profromal symptom.

Abalone Haemocyanin (AH) 50mg applied topically once daily for 5 days within 6 hours of profromal symptom.


Locations(1)

Australia

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ACTRN12611000920998