Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01208298
First received: September 22, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The primary objective of this study was to evaluate the safety and performance of a cold sore patch for the treatment of herpes labialis.


Condition Intervention
Herpes Labialis
Device: Cold Sore Patch

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study to Evaluate the Safety and Performance of Compeed® Cold Sore Patch Night in the Treatment of Herpes Labialis

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Clinician/Investigator's Global Assessment of Therapy [ Time Frame: at discontinuation of therapy within 10 days ] [ Designated as safety issue: No ]
    Scores based on a on a scale from 0 = No response to therapy; 1 = Barely perceptible or minimal response to therapy; 2 = Very slight or low response to therapy; 3 = Slight or low response to therapy; 4 = Slight/low to moderate response to therapy; 5 = Moderate response to therapy; 6 = Moderate to substantial response to therapy; 7 = Substantial response to therapy; 8 = Substantial to significant response to therapy; 9 = Significant response to therapy; 10 = Excellent response to therapy

  • Subject's Global Assessment of Therapy [ Time Frame: at discontinuation of therapy within 10 days ] [ Designated as safety issue: No ]
    Taking into account speed and quality of the response, subjects provided an overall assessment of the therapy with scores on a scale from 0= no response to 10= excellent response.


Secondary Outcome Measures:
  • Days to Heal [ Time Frame: at day "healed" within 10 days ] [ Designated as safety issue: No ]
    Clinician/Investigator's assessed time to healing. The day the Clinician's assessment of lesion stage was "healed" was used as the time to heal score.


Enrollment: 45
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: # 1727
Cold sore Patch
Device: Cold Sore Patch
All eligible subjects received CSP-Night at Screening Visit 1. Subjects were instructed to initiate therapy within approximately 1 hour of onset of their first sign or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All subjects were expected to return to the study center for clinical assessments within 24 hours and 48 hours after initiating treatment, and every other day thereafter, with a final visit at Day 10 or at the time of completion/ discontinuation if before Day 10.
Other Name: Compeed® Cold Sore Patch Night

Detailed Description:

This was an open, single-center multi-site, non-comparative study to evaluate the safety and performance of CSP-Night under actual-use conditions in subjects with herpes labialis of the lips and/or perioral skin. A sufficient number of subjects were screened to ensure that 45 subjects experienced and treated a cold sore outbreak in the course of 14 weeks. Subjects were instructed to initiate therapy within approximately 1 hour of onset of their first sign or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All subjects were expected to return to the study center for clinical assessments within 24 hours and 48 hours after initiating treatment, and every other day thereafter, with a final visit at Day 10 or at the time of completion/discontinuation if before Day 10. Diaries were completed each day, beginning upon initiation of therapy and continuing until study completion/ discontinuation, and included information on study product applications and compliance.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females or males subjects, at least 18 to 70 years of age, in good general health
  • History of recurrent herpes labialis (HSV-1) on the lips and/or perioral skin, with lesions typically manifesting as classical lesions (i.e., episodes progressing to vesicle, ulcer, and/or crust stages). Based on history, subject is considered likely to experience a cold sore outbreak within a time period of 2-3 months
  • Individuals who were willing and able to provide informed consent
  • Willing to stop all other treatment of this condition during the test period, including creams, tablets and other treatments
  • Agrees not to use any topical product (e.g., cosmetics, lip balms, sunscreens) on the lesion area other than study medication
  • Individuals who were willing to use the assigned test material for up to 10 consecutive days
  • Individuals who were willing and able to follow the requirements for study participation
  • Women of child bearing potential must agree to use an adequate method of birth control as defined by the protocol. Females who were post-menopausal (for at least 1 year), had a hysterectomy, bilateral ovariectomy or bilateral tubal ligation did not have to have additional birth control methods.

Exclusion Criteria:

  • Individuals who were self reported to be pregnant, planning to become pregnant or nursing
  • History of viral infection (e.g., hepatitis, HIV) or other condition likely to require treatment with systemic antiviral or steroid medications during the period of the study Note: Subjects suffering from chronic HSV and/ or have previously treated their herpes virus with systemic medication were permitted to be enrolled in this study.
  • History of any malignant diseases
  • Significant history of liver, kidney, heart, lung or digestive disease that required prolonged hospitalization or out-patient treatment
  • Significant history of blood, nerve, brain or psychiatric disorders that required prolonged hospitalization or out-patient treatment
  • Individuals with uncontrolled diabetes
  • History of dermatologic or other condition(s) that in the judgment of the investigator may affect the course of the cold sore lesion or interfere with the actions of the study treatment or confound the interpretation of the study results
  • Individuals using any analgesics or anti-inflammatory agents during the treatment period
  • Individuals which were taking or had taken within the past 30 days of commencing treatment, systemic antiviral or steroid therapy
  • Individuals which were taking or had taken within the past 7 days of commencing treatment, topical treatments for cold sore
  • Individuals which were taking herbal supplements within 28 days of first dose of study product
  • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
  • Individuals with known sensitivity to any ingredients in the test product
  • Individuals participating in another clinical research study, within 30 days of Visit 1 and at any time during the course of the treatment period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208298

Locations
United Kingdom
4 Front Research
Ellesmere Port, Cheshire, United Kingdom, CH65 4BW
Intertek
Manchester, United Kingdom, M15 6SX
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Qing Li, PhD Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01208298     History of Changes
Other Study ID Numbers: HCOWDH1001
Study First Received: September 22, 2010
Last Updated: October 4, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Cold Sore Patch

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014