Herpes LabialisNCT01484067
Study of a Cold Sore Patch for the Treatment of Herpes Labialis
A study testing Patch ( Compeed© Total CareTM Cold Sore Patch) in people with Herpes Labialis, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 1 site in United Kingdom.
Trial summary
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, because as soon as a cold sore starts (within 1 hour) they will need to put the patch over the sore. 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?
- Patch ( Compeed© Total CareTM Cold Sore Patch)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Mar 2012
- 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
- Female or male 18-70 years old in good general health
- Has a history of Herpes Labialis in the areas and with the frequency defined in the protocol.
- Based on history, likely to experience a cold sore outbreak within next 2 to 3 months
- Willing to provide informed consent
- Willing to stop all other treatment of this condition and any topical products (lip balm, cosmetics, sunscreen) during test period
- Women of child bearing potential must agree to use an adequate method of birth control (systemic birth control/intrauterine device)
Who cannot join
- Self-reported to be pregnant, planning to become pregnant or nursing
- Has any medical history or condition that might, per protocol or in the opinion of the investigator, compromise the subject's safety or the analysis of results.
- Is taking or has taken within the 28 days before commencing treatment, protocol-specified medications or herbal supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Clinician-Blind, Clinical Study to Examine the Safety and Performance of Compeed© Total Care™ Cold Sore Patch With Zinc Sulfate for the Treatment of Herpes Labialis
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, because as soon as a cold sore starts (within 1 hour) they will need to put the patch over the sore. The other group will not get a patch, but will need to follow the other instructions anyway.
When a subject's outbreak begins, they will need to return to the study center within 24 hours. Then they will return according to the appointments given within 10 days. If the study staff sees that their sore has healed enough before 10 days, subjects will be told that they don't need to return again.
Read more
As long as subjects are in the study, they will need to answer a few simple questions every day on a card or booklet called a diary, starting the first day of their outbreak. If a subject is assigned to the patch group, they must wear the patch all the time, taking it off only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when they are asked to remove the patch so the sore can be checked.
During the study subjects will be allowed to use paracetamol for pain, but no other treatments or medicine. If they use paracetamol, subjects must record it in their diary. The study will be stopped, and there will be no subject visits or treatments during the end of year holiday break. If a subject experiences an outbreak during the holiday, they may follow their usual treatment routine.
Read the detailed description
This is a two-arm, randomized, clinician-blind study. No severe adverse effects are expected to be experienced in the control group. All subjects are allowed to treat cold sore related pain with an oral analgesic - paracetamol (APAP). The use of APAP for pain will be recorded as a concomitant medication. However, subjects will be required to refrain from using any additional treatment (topical or systemic) during study participation.
Subjects randomized to treatment will be instructed to initiate the therapy within 1 hour onset of their first sign or symptom and record their assessment in the diary card (for no treatment subjects, they will only record assessments upon onset of first sign or symptom). All subjects will return to the study center for clinical assessments within 24 hours and 48 hours after onset of first sign or symptom/initiation of 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 will be completed each day, beginning upon initiation of therapy (Day 0) and continuing until study completion/discontinuation, and will include information on study product applications.
Subjects assigned to a patch treatment will wear a patch continuously on their lesion and will apply a new patch on occasions where the patch becomes loose, falls off or becomes unsightly, including at study visits to the facility where subjects will be asked to remove their patch for clinical assessments. Treatment will continue until the lesion is healed, for a maximum of 10 days. As the test period will possibly extend through the end of year holiday break, subject visits and treatments will be halted during this break. All subjects who have not initiated therapy including subjects assigned no treatment group, will be allowed to use their regular therapy for a cold sore outbreak during the holiday break.
- Conditions
- Herpes Labialis
- Being tested
- Patch ( Compeed© Total CareTM Cold Sore Patch)
- Keywords
- Herpes Simplex Virus
- Medical subject headings
- Herpes Labialis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch ( Compeed© Total CareTM Cold Sore Patch)Device
Also called Compeed© Total CareTM Cold Sore Patch
A cold sore patch containing zinc sulfate
| Study group | Role | What they receive |
|---|---|---|
| Patch | Experimental | At onset of signs/symptoms, subjects will apply assigned patch, and return to study center within 24 hours. Patch will be worn continuously, being replaced as needed. Receives: Device: Patch ( Compeed© Total CareTM Cold Sore Patch) |
| No Patch | No intervention | No treatment will be initiated at onset of signs and symptoms although subject is still required to return to study center with 24 hours of onset of signs/symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Condition of Cold Sore
Taking into account the size, physical impression of the lesion and overall quality of healing, clinician will score the overall condition of the cold sore on a scale of 0-10, where 0=Best and 10=Worst.
Measured: Within 10 Days
Erythema
Clinician's score on a scale of 0-10 for erythema, where 0=none and 10=most severe
Measured: Within 10 Days
Edema
Clinician's score on a scale of 0-10 for edema, where 0=none and 10=most severe
Measured: Within 10 Days
Vesicles
Clinician's score on a scale of 0-10 for vesicles, where 0=none and 10=most severe
Measured: Within 10 Days
Scab/Crust
Clinician's score on a scale of 0-10 for scab/crust, where 0=none and 10=most severe
Measured: Within 10 Days
Secondary outcomes (12)
Lesion Size
Measurement of lesion diameter
Measured: Within 10 Days
Lesion Stage
Lesion Stage on a categorical scale of 1-8, as described below:
- = prodrome (symptoms including itching, pain, tingling, but no physical evidence of disease by inspection or by palpation)
- = maculae (erythema)
- = papule (any elevation of skin without fluid; solid raised lesion)
- = vesicle (blister, fluid filled or collapsed)
- = ulcer/eroson (moist sore/wound)
- = soft crust/scab
- = hard crust/scab
- = healed (normal skin with no signs or symptoms; residual postlesion skin changes such as erythema, flaking, or slight asymmetry may be present)
Measured: Within 10 Days
Pain
Subject's score for unprovoked pain on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Discomfort
Subject's score for discomfort on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Itching
Subject's score for itching on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 days
Burning
Subject's score for burning on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Tingling
Subject's score for tingling on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Swelling
Subject's score for swelling on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Soreness/Tenderness
Subject's score for soreness/tenderness [upon touching] on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Redness
Subject's score for redness on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Blisters
Subject's score for blisters on a scale of 0-10, where 0=none and 10=most severe
Measured: Within 10 Days
Scab or Crust
Subject's score for scab or crust on a scale of 0-10, where 0=none and 10=most severe
Measured: 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 posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clare Kendall, Study director, Johnson & Johsnon Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484067
- Sponsor's protocol ID
- HCOWDH0003
- Other IDs
- 44-DRM-HLS-11-002
- Status last verified
- Sep 2012
- First submitted
- 30 Nov 2011
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Clinician-Blind, Clinical Study to Examine the Safety and Performance of Compeed© Total Care™ Cold Sore Patch With Zinc Sulfate for the Treatment of Herpes Labialis
- ClinicalTrials.gov ID
- NCT01484067
- Acronym / sponsor ID
- HCOWDH0003
- Conditions
- Herpes Labialis
- Keywords
- Herpes Simplex Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Dec 2011 (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.
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, because as soon as a cold sore starts (within 1 hour) they will need to put the patch over the sore. The other group will not get a patch, but will need to follow the other instructions anyway.
When a subject's outbreak begins, they will need to return to the study center within 24 hours. Then they will return according to the appointments given within 10 days. If the study staff sees that their sore has healed enough before 10 days, subjects will be told that they don't need to return again.
As long as subjects are in the study, they will need to answer a few simple questions every day on a card or booklet called a diary, starting the first day of their outbreak. If a subject is assigned to the patch group, they must wear the patch all the time, taking it off only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when they are asked to remove the patch so the sore can be checked.
During the study subjects will be allowed to use paracetamol for pain, but no other treatments or medicine. If they use paracetamol, subjects must record it in their diary. The study will be stopped, and there will be no subject visits or treatments during the end of year holiday break. If a subject experiences an outbreak during the holiday, they may follow their usual treatment routine.
Detailed description
This is a two-arm, randomized, clinician-blind study. No severe adverse effects are expected to be experienced in the control group. All subjects are allowed to treat cold sore related pain with an oral analgesic - paracetamol (APAP). The use of APAP for pain will be recorded as a concomitant medication. However, subjects will be required to refrain from using any additional treatment (topical or systemic) during study participation.
Subjects randomized to treatment will be instructed to initiate the therapy within 1 hour onset of their first sign or symptom and record their assessment in the diary card (for no treatment subjects, they will only record assessments upon onset of first sign or symptom). All subjects will return to the study center for clinical assessments within 24 hours and 48 hours after onset of first sign or symptom/initiation of 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 will be completed each day, beginning upon initiation of therapy (Day 0) and continuing until study completion/discontinuation, and will include information on study product applications.
Subjects assigned to a patch treatment will wear a patch continuously on their lesion and will apply a new patch on occasions where the patch becomes loose, falls off or becomes unsightly, including at study visits to the facility where subjects will be asked to remove their patch for clinical assessments. Treatment will continue until the lesion is healed, for a maximum of 10 days. As the test period will possibly extend through the end of year holiday break, subject visits and treatments will be halted during this break. All subjects who have not initiated therapy including subjects assigned no treatment group, will be allowed to use their regular therapy for a cold sore outbreak during the holiday break.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patch | Experimental | Device: Patch ( Compeed© Total CareTM Cold Sore Patch)At onset of signs/symptoms, subjects will apply assigned patch, and return to study center within 24 hours. Patch will be worn continuously, being replaced as needed. |
| No Patch | No intervention | –No treatment will be initiated at onset of signs and symptoms although subject is still required to return to study center with 24 hours of onset of signs/symptoms. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male 18-70 years old in good general health
- Has a history of Herpes Labialis in the areas and with the frequency defined in the protocol.
- Based on history, likely to experience a cold sore outbreak within next 2 to 3 months
- Willing to provide informed consent
- Willing to stop all other treatment of this condition and any topical products (lip balm, cosmetics, sunscreen) during test period
Key exclusion criteria (3 listed)
- Self-reported to be pregnant, planning to become pregnant or nursing
- Has any medical history or condition that might, per protocol or in the opinion of the investigator, compromise the subject's safety or the analysis of results.
- Is taking or has taken within the 28 days before commencing treatment, protocol-specified medications or herbal supplements.
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 |
|---|---|---|
| Patch ( Compeed© Total CareTM Cold Sore Patch)Also: Compeed© Total CareTM Cold Sore PatchA cold sore patch containing zinc sulfate | Device | Patch |
Primary outcome
Overall Condition of Cold Sore
Time frame: Within 10 Days
Taking into account the size, physical impression of the lesion and overall quality of healing, clinician will score the overall condition of the cold sore on a scale of 0-10, where 0=Best and 10=Worst.
Erythema
Time frame: Within 10 Days
Clinician's score on a scale of 0-10 for erythema, where 0=none and 10=most severe
Edema
Time frame: Within 10 Days
Clinician's score on a scale of 0-10 for edema, where 0=none and 10=most severe
Vesicles
Time frame: Within 10 Days
Clinician's score on a scale of 0-10 for vesicles, where 0=none and 10=most severe
Scab/Crust
Time frame: Within 10 Days
Clinician's score on a scale of 0-10 for scab/crust, where 0=none and 10=most severe
12 secondary outcomes
Lesion Size
Time frame: Within 10 Days
Lesion Stage
Time frame: Within 10 Days
Pain
Time frame: Within 10 Days
Discomfort
Time frame: Within 10 Days
Itching
Time frame: Within 10 days
Burning
Time frame: Within 10 Days
Tingling
Time frame: Within 10 Days
Swelling
Time frame: Within 10 Days
Soreness/Tenderness
Time frame: Within 10 Days
Redness
Time frame: Within 10 Days
Blisters
Time frame: Within 10 Days
Scab or Crust
Time frame: 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 1 Oct 2012.
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.
Clare Kendall study director
Johnson & Johsnon Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch ( Compeed© Total CareTM Cold Sore Patch) in people with Herpes Labialis, run by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. at 1 site 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 6 inclusion and 3 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 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Overall Condition of Cold Sore (time frame: Within 10 Days). The study lists 5 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 1 Oct 2012.