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

Sponsor

NanoBio Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01324466

Collaborator

(none)

847

Enrollment

Locations

Arms

Duration (Months)

24.2

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

Condition or Disease	Intervention/Treatment	Phase
Recurrent Herpes Labialis	Drug: NB-001 Drug: Vehicle	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

847 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Vehicle	Drug: Vehicle Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Active Comparator: Active Active NB-001(0.3%)	Drug: NB-001 Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Arm

Intervention/Treatment

Placebo Comparator: Vehicle

Vehicle

Drug: Vehicle

Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Active Comparator: Active

Active NB-001(0.3%)

Drug: NB-001

Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Outcome Measures

Primary Outcome Measures

Time of Healing of the primary lesion complex [Median time to healing (day 1 until up to 4 days)]
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

Secondary Outcome Measures

Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. [First Post-Treatment Visit (after maximum 15 clinical visits)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research, Inc.	Birmingham	Alabama	United States	35209
2	Elite Clinical Studies, LLC	Phoenix	Arizona	United States	85018
3	Radiant Research, Inc	Tucson	Arizona	United States	85710
4	Providence Clinical Research	Burbank	California	United States	91505
5	Axis Clinical Trials	Los Angeles	California	United States	90036
6	Axis Clinical Trials	Los Angeles	California	United States	90057
7	Staywell Research	Northridge	California	United States	91325
8	Front Range Clinical Research	Wheatridge	Colorado	United States	80033
9	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
10	Altus Research, Inc.	Lake Worth	Florida	United States	33461
11	Suncoast Clinical Research	New Port Richey	Florida	United States	34652
12	Radiant Research, Inc	Pinellas Park	Florida	United States	33781
13	Radiant Research, Inc. Chicago	Chicago	Illinois	United States	60654
14	DermResearch	Louisville	Kentucky	United States	40217
15	Commonwealth Biomedical Research	Madisonville	Kentucky	United States	42431
16	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri	United States	64114
17	Radiant Research, Inc.	St. Louis	Missouri	United States	63141
18	Meridian Clinical Research	Omaha	Nebraska	United States	68134
19	Axis Clinical Trials	New Hyde Park	New York	United States	11040
20	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
21	Upstate Clinical Research Associates	Williamsville	New York	United States	14221
22	Radiant Research, Inc.	Akron	Ohio	United States	44311
23	Radiant Research, Inc.	Cincinnati	Ohio	United States	45249
24	Paramount Clinical Research	Bridgeville	Pennsylvania	United States	15017
25	Omega Medical Research	Warwick	Rhode Island	United States	02886
26	Radiant Research, Inc.	Anderson	South Carolina	United States	29621
27	DermResearch, Inc.	Austin	Texas	United States	78759
28	Research Across America	Dallas	Texas	United States	75234
29	Benchmark Research - San Angelo	San Angelo	Texas	United States	76904
30	Radiant Research, Inc.	San Antonio	Texas	United States	78229
31	Utah Clinical Trials, LLC	Salt Lake City	Utah	United States	84107
32	South Valley Dermatology	West Jordan	Utah	United States	84088
33	IntegraTrials, LLC	Arlington	Virginia	United States	22205
34	National Clinical Research	Richmond	Virginia	United States	23294
35	Dermatology & Laser Center NW	Bellingham	Washington	United States	98225

Sponsors and Collaborators

NanoBio Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NanoBio Corporation

ClinicalTrials.gov Identifier:

NCT01324466

Other Study ID Numbers:

NB-001-005

First Posted:

Mar 29, 2011

Last Update Posted:

May 23, 2013

Last Verified:

May 1, 2013

Additional relevant MeSH terms:

Herpes Simplex

Herpes Labialis

Recurrence

5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol

Study Results

No Results Posted as of May 23, 2013