18 completed. 18 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 18 | Completed 18 |
| Phase 2 | 1 | Completed 1 |
Follow Lip Diseases: new trials by email Literature Review of Lip Diseases trials Research Report on Lip Diseases
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773, Placebo - Recurrent Herpes Labialis | Phase 3 | Completed | Bayer | 2020 | 2021-11-23 | 2025-09-02 |
| Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair Mesenchymal stem cells associated with biomaterials, Iliac crest autogenous bone graft - Cleft Lip and Palate | Phase 3 | Completed | Hospital Sirio-Libanes | 62 | 2019-04-05 | 2020-05-13 |
| Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis Acyclovir 5 percent (Perrigo), Acyclovir 5 percent (Reference), Placebo cream - Herpes Labialis | Phase 3 | Completed | Padagis LLC | 4076 | 2014-10-06 | 2021-10-22 |
| Silicone Gel in the Treatment of Cleft Lip Scars Silicone Gels - Cleft Lip | Phase 3 | Completed | Chang Gung Memorial Hospital | 33 | 2014-01-28 | 2017-10-24 |
| Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old acyclovir/hydrocortisone cream - Herpes Labialis | Phase 3 | Completed | Meda Pharmaceuticals | 54 | 2012-03-01 | 2014-05-22 |
| Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis Acyclovir 50mg/g, Penciclovir 10mg/g - Herpes Labialis | Phase 3 | Completed | EMS | 76 | 2012-02-01 | 2013-03-04 |
| A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS) NB-001, Vehicle - Recurrent Herpes Labialis | Phase 3 | Completed | NanoBio Corporation | 847 | 2011-04-01 | 2013-05-23 |
| A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis Vehicle versus NB-001 - Recurrent Herpes Simplex Labialis | Phase 3 | Completed | NanoBio Corporation | 907 | 2011-04-01 | 2013-05-23 |
| Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis Famciclovir - Herpes Labialis | Phase 2 / Phase 3 | Completed | Novartis Pharmaceuticals | 53 | 2009-03-25 | 2021-06-25 |
| Zinc for the Treatment of Herpes Simplex Labialis (HSL) Zicam (Ionic zinc), placebo - Herpes Simplex Labialis | Phase 3 | Completed | Integrative Medicine Institute | 157 | 2008-12-01 | 2014-01-08 |
| Phase 3 Clinical Study for the Treatment of Cold Sore Acyclovir Lauriad, Placebo - Herpes Labialis | Phase 3 | Completed | Valerio Therapeutics | 1727 | 2007-05-01 | 2012-12-21 |
| Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients ME-609, Acyclovir in ME-609 vehicle (5% acyclovir) - Herpes Labialis | Phase 3 | Completed | Medivir | 201 | 2006-12-01 | 2008-08-15 |
| Oral Cleft Prevention Program Folic acid: 4 mg versus 0.4 mg per day - Cleft Lip, Cleft Palate | Phase 3 | Completed | University of Iowa | 4000 | 2006-11-01 | 2017-03-31 |
| Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents ME-609 - Herpes Labialis | Phase 3 | Completed | Medivir | 254 | 2006-10-01 | 2008-08-18 |
| Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis ME-609, acyclovir in ME-609 vehicle, Vehicle - Herpes Labialis | Phase 3 | Completed | Medivir | 1443 | 2006-07-01 | 2008-08-18 |
| Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection Famciclovir - Herpes Simplex | Phase 3 | Completed | Novartis Pharmaceuticals | 74 | 2005-02-01 | 2013-04-25 |
| Oral Cleft Prevention Trial in Brazil Folic acid (0.4mg vs. 4.0mg) - Cleft Lip, Cleft Palate | Phase 3 | Completed | NICHD Global Network for Women's and Children's Health | 2200 | 2004-01-01 | 2013-12-17 |
| Phase II Trial of Allovectin-7® for Head and Neck Cancer Allovectin-7® - Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx | Phase 3 | Completed | Vical | 2008-06-24 |
Herpes Labialis (13) · Cleft Lip (4) · Cleft Palate (2) · Herpes Simplex (2) · Carcinoma (1) · Cicatrix (1) · Congenital Abnormalities (1) · Head and Neck Neoplasms (1) · Laryngeal Diseases (1) · Lip Neoplasms (1) · Neoplasms (1) · Otorhinolaryngologic Neoplasms (1) · Squamous Cell Carcinoma of Head and Neck (1) · Tongue Neoplasms (1)
Mouth Diseases (18) · Stomatognathic Diseases (18) · DNA Virus Infections (13) · Herpesviridae Infections (13) · Infections (13) · Skin Diseases (13) · Skin Diseases, Infectious (13) · Skin Diseases, Viral (13) · Skin and Connective Tissue Diseases (13) · Virus Diseases (13) · Herpes Simplex (11) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (4) · Mouth Abnormalities (4) · Stomatognathic System Abnormalities (4)
Acyclovir (5) · ME 609 (3) · Famciclovir (2) · Folic Acid (2) · 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol (1) · Allovectin-7 (1) · Biocompatible Materials (1) · Silicone Gels (1) · Tablets (1) · penciclovir (1)
Medivir (3) · NanoBio Corporation (2) · Novartis Pharmaceuticals (2) · Bayer (1) · Chang Gung Memorial Hospital (1) · EMS (1) · Hospital Sirio-Libanes (1) · Integrative Medicine Institute (1) · Meda Pharmaceuticals (1) · NICHD Global Network for Women's and Children's Health (1) · Padagis LLC (1) · University of Iowa (1) · Valerio Therapeutics (1) · Vical (1)
United States (12) · Brazil (3) · Australia (1) · Czechia (1) · France (1) · Germany (1) · Panama (1) · Poland (1) · Taiwan (1) · United Kingdom (1)
Anders Strand, MD PhD (1) · Christopher M Hull, MD (1) · David Ginsburg, D.O. (1) · David S Riley, MD (1) · Flavia Addor, MD (1) · Jeff Murray, M.D. (1) · Jeffrey Murray, MD (1)
PMID 19273678, PMID 20851499, PMID 21178655, PMID 23181832, PMID 23669628
U01DE017958 (1)