Herpes LabialisNCT01208298
Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis
A study testing Cold Sore Patch in people with Herpes Labialis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Cold Sore Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
4 Front Research
Ellesmere Port, Cheshire, CH65 4BW
Intertek
Manchester, Manchester, M15 6SX
About this study
Official title: Study to Evaluate the Safety and Performance of Compeed® Cold Sore Patch Night in the Treatment of Herpes Labialis
The primary objective of this study was to evaluate the safety and performance of a cold sore patch for the treatment of herpes labialis.
Read the 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.
- Conditions
- Herpes Labialis
- Being tested
- Cold Sore Patch
- Keywords
- Cold Sore Patch
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Sore PatchDevice
Also called Compeed® Cold Sore Patch Night
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.
| Study group | Role | What they receive |
|---|---|---|
| # 1727 | Experimental | Cold sore Patch Receives: Device: Cold Sore Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician/Investigator's Global Assessment of Therapy
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
Measured: at discontinuation of therapy within 10 days
Subject's Global Assessment of Therapy
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.
Measured: at discontinuation of therapy within 10 days
Secondary outcomes (1)
Days to Heal
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.
Measured: at day "healed" within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208298
- Sponsor's protocol ID
- HCOWDH1001
- Status last verified
- Oct 2011
- First submitted
- 22 Sep 2010
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety and Performance of Compeed® Cold Sore Patch Night in the Treatment of Herpes Labialis
- ClinicalTrials.gov ID
- NCT01208298
- Acronym / sponsor ID
- HCOWDH1001
- Conditions
- Herpes Labialis
- Keywords
- Cold Sore Patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| # 1727 | Experimental | Device: Cold Sore PatchCold sore Patch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Sore PatchAlso: Compeed® Cold Sore Patch NightAll 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. | Device | # 1727 |
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.
1 secondary outcome
Days to Heal
Time frame: at day "healed" within 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Li, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Sore Patch in people with Herpes Labialis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician/Investigator's Global Assessment of Therapy (time frame: at discontinuation of therapy within 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.