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

Herpes Labialis (cold sores)

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a topical gel made from Abalone Haemocyanin (a protein from live abalone) can help treat cold sores (herpes labialis) caused by the herpes simplex virus. People who get frequent cold sores may benefit from this potential new treatment. Participants apply the gel or a placebo (inactive gel) for 5 days and researchers will see whether it reduces healing time or symptom severity. You may be eligible if: - You are between 18 and 65 years old - You have a history of recurring cold sores - You have had at least 3 cold sore episodes in the past 12 months You may NOT be eligible if: - You have a significant unstable medical condition - You have a known allergy or sensitivity to haemocyanin or to shellfish/seafood Talk to your doctor about whether this trial might be right for you.

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Interventions

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