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Home › Conditions › Herpes Labialis

Herpes Labialis

Part of Herpesviridae Infections

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Herpes Labialis

10 trials tracked for Herpes Labialis: 5 in phase 3 or 4 and 1 with published results. The most-cited published study has 10 citations.

10Trials tracked
5Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 4 1 Phase 3 4 Phase 2 2 Phase 1 3
  1. Phase 3 Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis Completed · 10 cited
  2. Phase 4 VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2 Completed
  3. Phase 3 Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis Completed
  4. Phase 3 Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old Completed
  5. Phase 3 Phase 3 Clinical Study for the Treatment of Cold Sore Completed
  6. Phase 2 Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes Completed
Show 4 more trials
  1. Phase 2 Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis Completed
  2. Phase 1 Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1) Completed
  3. Phase 1 An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode Completed
  4. Phase 1 Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis Completed

Showing the 10 most-cited and recently-updated of 10 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Herpes Labialis: what the trials found

Clinical trials have evaluated several pharmacological interventions for Herpes Labialis and related HSV infections. Acyclovir Lauriad demonstrated a statistically significant reduction in the time to healing (TTH) of vesicular primary lesions compared to other treatments (p=0.015) and showed significantly higher rates of abortion of primary lesions (p=0.0419) 5.

Valacyclovir has been shown to significantly reduce the mean percent days of both clinical and subclinical shedding for HSV-2, with significant results observed in both categories (p=<0.001; p=0.014) 1. Other established interventions include acyclovir 5 percent (Perrigo) 3, famciclovir 2, and acyclovir/hydrocortisone cream 4.

Recent results — preliminary, needs further review

  • SADBE showed a mean of 128, 163, and 174 days to the next herpes labialis episode following initial dosing (not yet corroborated) 6.
  • Pritelivir 5% w/w ointment did not show statistically significant results in efficacy measured by percentage of subjects with non-ulcerative lesions (p=0.4294) (not yet corroborated) 7.
  • Squaric Acid solution resulted in 62.96% and 20% of subjects having no outbreaks within 119 days of sensitization (not yet corroborated) 9.
  • Acyclovir patch showed a statistically significant mean change from baseline in temperature (p=0.0486), though changes in blood flow and color intensity were not statistically significant (not yet corroborated) 10.

For the clinician treating this condition

  • Acyclovir Lauriad is effective for the abortion of primary lesions and reducing time to healing for vesicular primary lesions.
  • Valacyclovir significantly reduces both clinical and subclinical shedding durations in HSV-2 infections.

AI synthesis of 9 cited trials, updated Jun 20, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
FDA Approves Abreva () for cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms
Dermatology FDA Approval
FDA Approves Abreva () for cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms The FDA has approved a new non-prescription drug called Abreva for treating cold sores
The FDA approved Abreva for treating cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms such as …
FDA approves new over-the-counter drug Abreva to shorten cold sore healing time and ease painful symptoms like tingling and itching.
FDA Apr 17, 2026

Research across Herpesviridae Infections

Related studies from across the Herpesviridae Infections family.

Acyclovir treatment for HSV in febrile hospitalized children at Jinan Children's Hospital
Pediatrics Cohort
Acyclovir treatment for HSV in febrile hospitalized children at Jinan Children's Hospital The hidden troublemaker
This retrospective cohort study evaluated 100 febrile hospitalized children at Jinan Children's Hospital.
Finding a second germ alongside Herpes Simplex Virus in sick children explains why some stay hospitalized longer than expected.
Frontiers Apr 16, 2026
Meta-analysis finds topical propolis/honey associated with faster herpes lesion resolution than acyclovir
Infectious Disease Meta-analysis
Meta-analysis finds topical propolis/honey associated with faster herpes lesion resolution than acyclovir Topical propolis and honey may help heal herpes lesions faster than acyclovir cream
A meta-analysis of 7 studies compared topical propolis and/or honey to 5% topical acyclovir for labial and genital herpes lesions.
Using natural propolis or honey on herpes sores healed lesions nearly two days faster and cut pain compared to standard acyclovir cream.
Apr 6, 2026
Global neonatal HSV incidence 8.2 per 100k births, rising 3.5% annually; nHSV-1 proportion increasing
Pediatrics Meta-analysis
Global neonatal HSV incidence 8.2 per 100k births, rising 3.5% annually; nHSV-1 proportion increasing A dangerous virus is affecting more newborns worldwide, with cases rising each year
A systematic review and meta-analysis found the global pooled incidence of neonatal herpes simplex virus (nHSV) is 8.2 per 100,000 live birt…
A dangerous newborn infection is rising worldwide, with cases increasing by 3.5% each year and highest rates now seen in the Americas.
Mar 30, 2026