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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better way to treat cold sores, painful blisters on the mouth caused by the herpes simplex virus. It compares the effectiveness of an acyclovir buccal (gum-adhering) tablet to a placebo (a non-active treatment) to determine which heals cold sores faster. People who have experienced at least four cold sore outbreaks in the past year might be suitable candidates for this study. Participants will apply the tablet once and check in with doctors online to track healing. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that acyclovir is generally safe and effective for treating cold sores caused by the herpes simplex virus (HSV). The FDA has approved acyclovir for this use, and extensive safety information is available due to its widespread use.

In past studies, individuals using acyclovir cream for cold sores mostly reported mild side effects, such as a temporary burning or stinging sensation at the application site. These studies have not linked any serious side effects to its use. The buccal tablet, which adheres to the gum, delivers the medicine directly to the affected area, similar to the cream's action on the skin.

Overall, acyclovir is considered safe for treating cold sores when used as directed. However, it is important to follow the instructions and consult a doctor if any concerns arise. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cold sores?

Unlike the standard cold sore treatments that are typically creams or ointments applied to the skin, this new acyclovir formulation is a buccal/topical tablet. Researchers are excited because this method allows the medication to be absorbed directly through the cheek, potentially offering faster relief and making it easier to use. Additionally, the precise dosage in tablet form could improve consistency in treatment effectiveness compared to other methods.

What is the effectiveness track record for acyclovir in treating cold sores?

Research shows that acyclovir, which participants in this trial may receive, can shorten the duration of cold sores. Studies have found that antiviral treatments like acyclovir can make cold sores heal about one day faster than without treatment. One study found that acyclovir reduced the number of cold sore outbreaks by 53% and decreased the duration of viral activity by 71%. This indicates that acyclovir can help reduce the frequency and duration of cold sore episodes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK525789/

Cold sores: Learn More – How effective are creams ... - NCBI Antiviral medications like acyclovir or penciclovir can make cold sores go away about one day sooner. If you decide to use one, it's important ...

2. uptodate.com uptodate.com/contents/treatment-and-prevention-of-herpes-simplex-virus-type-1-in-immunocompetent-adolescents-and-adults

Treatment and prevention of herpes simplex virus type 1 in ... Valacyclovir shortened outbreaks by approximately one day compared with placebo; treatment for one day was as effective as treatment for two ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8380540/

Oral acyclovir to suppress frequently recurrent herpes ... Treatment with acyclovir in this study resulted in a 53% reduction in the number of clinical recurrences and a 71% reduction in virus culture-positive ...

4. fda.gov fda.gov/files/drugs/published/020639-Acyclovir-Clinical-Stats-PREA.pdf

020639 Acyclovir Clinical-Stats PREA FDA review of NDA 21-478 Zovirax cream. 4. Spruance, S.L., et al., Acyclovir cream for treatment of herpes simplex labialis: results of two.

5. journals.asm.org journals.asm.org/doi/10.1128/aac.47.3.1072-1080.2003

High-Dose, Short-Duration, Early Valacyclovir Therapy for ... These studies provide evidence supporting a simple, 1-day valacyclovir treatment regimen for cold sores that is safe and effective.

6. vionausa.com vionausa.com/wp-content/uploads/2023/03/SDS-Acyclovir-Cream-Ver.-01.pdf

Safety Data Sheet Acyclovir Cream, 5% Strength: 5 % Pack Size Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis i.e., during the prodrome or when lesions appear.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/021478s007lbl.pdf

3481551 This label may not be the latest approved by FDA ... Patients should be advised that ZOVIRAX Cream should not be used in the eye, inside the mouth or nose, or on the genitals.

8. pi.bauschhealth.com pi.bauschhealth.com/globalassets/bhc/pi/zoviraxcream.pdf

ZOVIRAX- acyclovir cream Bausch Health US, LLC ZOVIRAX Cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/acyclovir-topical-route/description/drg-20061579

Acyclovir (topical route) - Side effects & dosage Topical acyclovir is used to treat the symptoms of herpes simplex virus infections of the skin, mucous membranes, and genitals (sex organs).

10. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0da14760-1131-4936-9a42-c40fc4db5cd0

ZOVIRAX® (acyclovir) Cream 5%USE ONLY FOR COLD ... ZOVIRAX Cream should only be used on herpes labialis on the affected external aspects of the lips and face. Because no data are available, application to human ...