Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01484067
Other study ID # HCOWDH0003
Secondary ID 44-DRM-HLS-11-00
Status Completed
Phase N/A
First received November 30, 2011
Last updated September 27, 2012
Start date November 2011
Est. completion date March 2012

Study information

Verified date September 2012
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 472
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Patch ( Compeed© Total CareTM Cold Sore Patch)
A cold sore patch containing zinc sulfate

Locations

Country Name City State
United Kingdom Intertek CRS Manchester

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 10 Days No
Primary Erythema Clinician's score on a scale of 0-10 for erythema, where 0=none and 10=most severe Within 10 Days No
Primary Edema Clinician's score on a scale of 0-10 for edema, where 0=none and 10=most severe Within 10 Days No
Primary Vesicles Clinician's score on a scale of 0-10 for vesicles, where 0=none and 10=most severe Within 10 Days No
Primary Scab/Crust Clinician's score on a scale of 0-10 for scab/crust, where 0=none and 10=most severe Within 10 Days No
Secondary Lesion Size Measurement of lesion diameter Within 10 Days No
Secondary 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)
Within 10 Days No
Secondary Pain Subject's score for unprovoked pain on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Discomfort Subject's score for discomfort on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Itching Subject's score for itching on a scale of 0-10, where 0=none and 10=most severe Within 10 days No
Secondary Burning Subject's score for burning on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Tingling Subject's score for tingling on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Swelling Subject's score for swelling on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Soreness/Tenderness Subject's score for soreness/tenderness [upon touching] on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Redness Subject's score for redness on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Blisters Subject's score for blisters on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
Secondary Scab or Crust Subject's score for scab or crust on a scale of 0-10, where 0=none and 10=most severe Within 10 Days No
See also
  Status Clinical Trial Phase
Completed NCT02483182 - Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores Phase 2
Completed NCT00297011 - Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis Phase 2
Completed NCT03310294 - Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis N/A
Terminated NCT04539483 - Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection Phase 2
Completed NCT02265913 - Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis Phase 3
Completed NCT01971385 - Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis Phase 1
Active, not recruiting NCT01695187 - NB-001 Treatment of Recurrent Herpes Labialis Phase 3
Completed NCT00375570 - Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents Phase 3
Completed NCT02871492 - Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes Phase 2
Completed NCT00769314 - Phase 3 Clinical Study for the Treatment of Cold Sore Phase 3
Completed NCT00878072 - Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis Phase 2/Phase 3
Completed NCT01574612 - Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old Phase 3
Completed NCT03661541 - Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1) Phase 1
Recruiting NCT01306084 - Viral Infections in Healthy and Immunocompromised Hosts
Terminated NCT03521479 - A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis Phase 2
Terminated NCT00913692 - A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis Phase 2
Completed NCT02207881 - A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis Phase 2
Completed NCT01653509 - An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode Phase 1
Completed NCT00361881 - Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis Phase 3
Recruiting NCT02582086 - Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis N/A