A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NanoBio Corporation
ClinicalTrials.gov Identifier:
NCT01321359
First received: March 22, 2011
Last updated: May 15, 2013
Last verified: May 2013

March 22, 2011
May 15, 2013
April 2011
January 2012   (final data collection date for primary outcome measure)
Time of Healing of the primary lesion complex [ Time Frame: Days ] [ Designated as safety issue: No ]
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. Time to healing is the time from application of the first dose to investigator assessed healing
Same as current
Complete list of historical versions of study NCT01321359 on ClinicalTrials.gov Archive Site
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. [ Time Frame: First Post-Treatment Visit ] [ Designated as safety issue: No ]
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.
Same as current
Not Provided
Not Provided
 
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis

Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.

Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.

At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Recurrent Herpes Simplex Labialis
Drug: Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
  • Placebo Comparator: Vehicle
    Vehicle
    Intervention: Drug: Vehicle versus NB-001
  • Active Comparator: Active
    Active NB-001(0.3%)
    Intervention: Drug: Vehicle versus NB-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
907
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A Healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study.
  • Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months;
  • Have the majority of their cold sore recurrences proceeded by a well defined history of prodromal symptoms.

Exclusion Criteria:

  • Subjects with severe chronic illness
  • Received (within the last 6 months) or receiving chemotherapy;
  • Significant skin disease on the face
  • Previously received herpes vaccine;
  • Active alcohol or drug abuse;
  • Prior randomization into any NanoBio study;
  • Known allergies to topical creams, ointments or other topical medications.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01321359
NB-001-004
No
NanoBio Corporation
NanoBio Corporation
Not Provided
Not Provided
NanoBio Corporation
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP