Herpes labialis
diseaseOn this page
Also known as blister, feverblisters, fevercold sorecold soresfever blisterfever blistersHerpes simplex, labiallabial Herpes simplexSore, coldSores, cold
Summary
Herpes labialis (MONDO:0043653) is a disease and 44 clinical trials. Top therapeutic interventions include acyclovir, alcohol, and famciclovir. A subtype of herpes simplex infectious disease — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Clinical trials: 44
Clinical features
No curated clinical features (Orphanet) for this disease.
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | herpes labialis |
| Mondo ID | MONDO:0043653 |
| MeSH | D006560 |
| NCIT | C34695 |
| SNOMED CT | 1475003 |
| UMLS | C0019345 |
| MedGen | 5533 |
| Anatomy (UBERON) | UBERON:0001833 |
| Is cancer (heuristic) | no |
Also known as: blister, fever · blisters, fever · cold sore · cold sores · fever blister · fever blisters · herpes labialis · Herpes simplex, labial · labial Herpes simplex · Sore, cold · Sores, cold
Disease family
This is a subtype of herpes simplex infectious disease. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by etiologic mechanism › disease of primarily extrinsic mechanism › infectious disease › viral infectious disease › primary viral infectious disease › Herpesviridae infectious disease › herpes simplex infectious disease › herpes labialis
Related subtypes (9): herpetic whitlow, herpes simplex dermatitis, genital herpes, herpes simplex virus gingivostomatitis, herpes simplex encephalitis, herpes simplex virus keratitis, congenital herpes simplex virus infection, herpes simplex type 1 infectious disease, herpes simplex type 2 infectious disease
Subtypes (2): lip herpes simplex type 1 infectious disorder, lip herpes simplex type 2 infectious disorder
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated for this disease
8 approved, 2 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.
| Drug | Development status |
|---|---|
| Acyclovir | Approved (phase 4) |
| Camphor | Approved (phase 4) |
| Famciclovir | Approved (phase 4) |
| Hydrocortisone | Approved (phase 4) |
| Menthol | Approved (phase 4) |
| Penciclovir | Approved (phase 4) |
| Phenol | Approved (phase 4) |
| Valacyclovir | Approved (phase 4) |
| NB-001 | Phase 3 (in late-stage trials) |
| Zinc Ion | Phase 3 (in late-stage trials) |
Earlier-phase candidates (phase 2, investigational — efficacy not yet established): 2-HYDROXYPROPYL-BETA-CYCLODEXTRIN, Alcohol, Clobetasol, Glutamine, Glycine, Pritelivir.
Clinical trials & evidence
Clinical trials
Clinical trials: 44.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| PHASE2 | 15 |
| PHASE3 | 10 |
| Not specified | 10 |
| PHASE1 | 4 |
| PHASE4 | 3 |
| PHASE2/PHASE3 | 1 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00248144 | PHASE4 | COMPLETED | A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis |
| NCT00306293 | PHASE4 | COMPLETED | VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2 |
| NCT00820534 | PHASE4 | COMPLETED | A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers |
| NCT00361881 | PHASE3 | COMPLETED | Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis |
| NCT00375570 | PHASE3 | COMPLETED | Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents |
| NCT00735761 | PHASE3 | COMPLETED | Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients |
| NCT00769314 | PHASE3 | COMPLETED | Phase 3 Clinical Study for the Treatment of Cold Sore |
| NCT00878072 | PHASE2/PHASE3 | COMPLETED | Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis |
| NCT01257074 | PHASE3 | COMPLETED | Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis |
| NCT01324466 | PHASE3 | COMPLETED | A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS) |
| NCT01574612 | PHASE3 | COMPLETED | Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old |
| NCT01695187 | PHASE3 | UNKNOWN | NB-001 Treatment of Recurrent Herpes Labialis |
| NCT02265913 | PHASE3 | COMPLETED | Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis |
| NCT05098938 | PHASE3 | COMPLETED | A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally |
| NCT00230867 | PHASE2 | COMPLETED | Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis |
| NCT00297011 | PHASE2 | COMPLETED | Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis |
| NCT00453401 | PHASE2 | COMPLETED | Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis |
| NCT00469300 | PHASE2 | COMPLETED | Iontophoretic Application of Acyclovir Gel to Treat Cold Sores |
| NCT00736437 | PHASE2 | COMPLETED | Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis |
| NCT00913692 | PHASE2 | TERMINATED | A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis |
| NCT00914745 | PHASE2 | COMPLETED | Place Controlled Study to Treat Recurrent Herpes Labialis. |
| NCT01985321 | PHASE2 | COMPLETED | Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores |
| NCT02207881 | PHASE2 | COMPLETED | A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis |
| NCT02483182 | PHASE2 | COMPLETED | Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores |
| NCT02871492 | PHASE2 | COMPLETED | Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes |
| NCT02965781 | PHASE1/PHASE2 | COMPLETED | Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis |
| NCT03192306 | PHASE2 | COMPLETED | Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores |
| NCT03521479 | PHASE2 | TERMINATED | A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis |
| NCT03977792 | PHASE2 | UNKNOWN | An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis |
| NCT04539483 | PHASE2 | TERMINATED | Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection |
| NCT00711776 | PHASE1 | COMPLETED | Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers |
| NCT01653509 | PHASE1 | COMPLETED | An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode |
| NCT01971385 | PHASE1 | COMPLETED | Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis |
| NCT03661541 | PHASE1 | COMPLETED | Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1) |
| NCT01306084 | Not specified | RECRUITING | Viral Infections in Healthy and Immunocompromised Hosts |
| NCT01208298 | Not specified | COMPLETED | Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis |
| NCT01225341 | Not specified | TERMINATED | Botulinum Toxin A for Herpes Labialis |
| NCT01484067 | Not specified | COMPLETED | Study of a Cold Sore Patch for the Treatment of Herpes Labialis |
| NCT02582086 | Not specified | UNKNOWN | Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis |
| NCT03307772 | Not specified | COMPLETED | Immune Response to the Consumption of Lactobacillus GG and FOS in Patients With Recurrent Herpes Labialis |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| ACYCLOVIR | 4 | 6 |
| ALCOHOL | 4 | 2 |
| FAMCICLOVIR | 4 | 2 |
| PENCICLOVIR | 4 | 2 |
| VALACYCLOVIR | 4 | 2 |
| GLUTAMINE | 4 | 1 |
| GLYCINE | 4 | 1 |
| NB-001 | 3 | 3 |
| PRITELIVIR | 3 | 1 |
| SQUARIC ACID DIBUTYL ESTER | 2 | 2 |
| ISOXAFLUTOLE | 2 | 1 |
| VEHICLE | 0 | 2 |
Related Atlas pages
- Drugs: Acyclovir, Alcohol, Famciclovir, Penciclovir, Valacyclovir, Glutamine, Glycine, NB-001, Pritelivir