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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000920998

Enrollment

210

Registered

2011-08-29

Start date

2011-08-25

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results