Zinc for the Treatment of Herpes Simplex Labialis (HSL)

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Integrative Medicine Institute
• Collaborators: Beth Israel Medical Center; Matrixx Initiatives, Inc.; Southwest College of Naturopathic Medicine; Women's Health Services, Santa Fe, New Mexico
• Treatments: Zinc

Criteria

Inclusion Criteria:

• Subjects with a history of HSL with at least 2 episodes/year for the past two years that have proceeded beyond the prodromal (initial) stage

• Male or female subjects between 18 and 65 years of age

• Symptoms or signs of HSL for less than one day (max. 36 hours from onset of symptoms to first visit)

• Confirmation of HSL by a clinician at the study site

• Willing to comply with study instructions and sign an informed consent

Exclusion Criteria:

• HSL symptoms or signs for more than one day

• Cold sore outbreak within the past 2 weeks

• Previous participation in this clinical trial

• Topical or oral antiviral drug use in the past 1 week

• Immune deficiency (HIV positive), chronic steroid therapy, present anti-neoplastic or radiation therapy, Hodgkin's disease, splenectomy, leukemia, myeloma, lymphoma, or another condition/drug per judgment of attending health care professional) or currently taking immune suppressive drugs. Previous organ or bone marrow transplant.

• Pregnancy or lactation

• Unable to travel to the clinic area for the required visits

• Apparent inability to understand or follow the instructions associated with the clinical study

• History of adverse events to the study material or facial cosmetics