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:

NCT01324466

First received: March 22, 2011

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2011
Last Updated Date	January 16, 2012
Start Date ^ICMJE	April 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 28, 2011)	Time of Healing of the primary lesion complex [ Time Frame: Median time to healing (day 1 until up to 4 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01324466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 28, 2011)	Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. [ Time Frame: First Post-Treatment Visit (after maximum 15 clinical visits) ] [ 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
Official Title ^ICMJE	A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
Brief Summary	The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Recurrent Herpes Labialis
Intervention ^ICMJE	Drug: NB-001 Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days Drug: Vehicle Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Study Arm (s)	Placebo Comparator: Vehicle Vehicle Intervention: Drug: Vehicle Active Comparator: Active Active NB-001(0.3%) Intervention: Drug: NB-001
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	847
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 preceded 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01324466
Other Study ID Numbers ^ICMJE	NB-001-005
Has Data Monitoring Committee	No
Responsible Party	NanoBio Corporation
Study Sponsor ^ICMJE	NanoBio Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NanoBio Corporation
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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