Clinical Trial: Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study to Evaluate the Safety and Performance of Compeed® Cold Sore Patch Night in the Treatment of Herpes Labialis

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

Detailed Summary: 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.
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Current Primary Outcome:

  • Clinician/Investigator's Global Assessment of Therapy [ Time Frame: at discontinuation of therapy within 10 days ]
    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 ]
    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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Days to Heal [ Time Frame: at day "healed" within 10 days ]

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.


Original Secondary Outcome: Same as current

Information By: Johnson & Johnson Consumer and Personal Products Worldwide

Dates:
Date Received: September 22, 2010
Date Started: April 2009
Date Completion:
Last Updated: October 4, 2011
Last Verified: October 2011