Acyclovir for Cold Sores

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must not be taking: Anti-inflammatory, Anti-herpetic

Disqualifiers: Immunocompromised, Renal disease, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

2019 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

During the treatment phase, you will need to avoid using anti-inflammatory drugs (except low-dose aspirin), anti-herpetic, antibiotic, antiviral agents, and steroids or other natural products that could affect your immune system.

What data supports the effectiveness of the drug Acyclovir for cold sores?

Acyclovir has been shown to be effective in treating other herpes-related conditions, such as herpetic keratitis and genital herpes, by improving symptoms and speeding up healing. However, a study specifically on cold sores (herpes labialis) found no significant benefit from using acyclovir cream compared to a placebo. ^{1 2 3 4 5}

Is acyclovir safe for humans?

Acyclovir is generally considered safe for humans, with the most common side effects being mild, such as irritation at the injection site and occasional kidney-related issues during high-dose intravenous use. It has been used safely in various forms, including topical, oral, and intravenous, for treating herpes infections. ^{6 7 8 9 10}

How does the drug acyclovir differ from other treatments for cold sores?

Acyclovir is unique because it specifically targets the herpes virus by inhibiting its DNA polymerase, which is crucial for the virus to replicate. It can be administered in various forms, including topically, orally, and intravenously, offering flexibility in treatment options. ^{4 8 11 12 13}

What is the purpose of this trial?

This trial is testing a small tablet that sticks to the gum and releases medicine to treat cold sores. It targets people who frequently get cold sores. The medicine works by stopping the virus from multiplying and spreading, which helps heal the sores faster.

Eligibility Criteria

Adults 18+ with frequent cold sores (at least 4 episodes in the past year) can join this trial. Participants must not disturb their cold sore lesions, be willing to avoid certain medications and treatments that affect immune response, and follow study instructions. Women of childbearing age need effective birth control and a negative pregnancy test.

Inclusion Criteria

I agree not to disturb the area where my disease might start or has started.

I am using birth control and my pregnancy test was negative.

Willing to avoid certain medications during the treatment phase

Exclusion Criteria

I am allergic to acyclovir or similar medications.

Over half of my health issues resolved on their own in the last year.

I have oral conditions that could be confused with cold sores.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply either acyclovir 50mg buccal tablet or placebo to the upper gum and undergo virtual meetings for assessments

2 weeks

2 virtual meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment with virtual check-ins and e-diary/App reporting

12 months

4 virtual calls

Treatment Details

Interventions

• Acyclovir

Trial Overview The trial is testing if a buccal tablet containing Acyclovir (50mg), which sticks to the gum inside the mouth, is more effective than a placebo at treating herpes labialis. The main focus is on how quickly symptoms disappear after treatment over a period of up to 20 months with virtual check-ins.

Participant Groups

Group I: Acyclovir 50mg buccal/topical tablet treatment group Experimental Treatment 1 Intervention

Group II: Matching placebo group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of herpetic keratitis with acyclovir: benefits and problems. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Acyclovir for treatment of varicella in immunecompetent patients. [2013]

3. Italy pubmed.ncbi.nlm.nih.gov

A double blind, placebo controlled trial of efficacy and safety of oral acyclovir (Zovirax) in the treatment of chickenpox in adults. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Acyclovir. Pharmacology and clinical experience. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Failure of acyclovir cream in treatment of recurrent herpes labialis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Drugs five years later: acyclovir. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Localized bullous eruptions away from infusion site due to intravenous acyclovir administration in a child. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Acyclovir: mechanism of action, pharmacokinetics, safety and clinical applications. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Acyclovir and herpesvirus infections. A review of the literature. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Multicenter collaborative trial of intravenous acyclovir for treatment of mucocutaneous herpes simplex virus infection in the immunocompromised host. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Acyclovir concentrations in the skin of humans after a single oral dose assessed by in vivo cutaneous microdialysis. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

The clinical use of intravenous acyclovir. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Acyclovir - a review of the preclinical and early clinical data of a new antiherpes drug. [2019]