Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01653509
Other study ID # E7411153
Secondary ID
Status Completed
Phase Phase 1
First received July 19, 2012
Last updated July 10, 2014
Start date July 2012
Est. completion date September 2012

Study information

Verified date February 2014
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Study type Interventional

Clinical Trial Summary

This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Acyclovir patch
Patch containing acyclovir
Placebo patch
Patch without acyclovir

Locations

Country Name City State
Germany proDERM Institute for Applied Dermatological Research GmbH Hamburg

Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline Labtec GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in Blood Flow Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique.
Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days.
Baseline to Day 10 No
Primary Mean Change From Baseline in Temperature Lesion thermographic parameters for TEV and MEV were analysed. Baseline to Day 10 No
Primary Mean Change From Baseline in Color Intensity of Lesions The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity). Baseline to Day 10 No
Secondary Participant Assessment of Patch Comfort and Noticeability at Day 5 Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
Today my sore felt completely protected
Today my cold sores interfered with facial movements such as smiling, eating or drinking
Today my cold sores interfered with my interaction with other people
Today the patch disguised my cold sores
Today I was bothered by the appearance of my cold sores
Today my patch was easy to apply
Today the patch covering my cold sores was bothersome
Today the patches stayed in place on my cold sores until I removed them
Today the patches were easy to remove from my lip or skin
Day 5 No
Secondary Participant Assessment of Patch Comfort and Noticeability at Day 10 Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
Today my sore felt completely protected
Today my cold sores interfered with facial movements such as smiling, eating or drinking
Today my cold sores interfered with my interaction with other people
Today the patch disguised my cold sores
Today I was bothered by the appearance of my cold sores
Today my patch was easy to apply
Today the patch covering my cold sores was bothersome
Today the patches stayed in place on my cold sores until I removed them
Today the patches were easy to remove from my lip or skin
Day 10 No
Secondary Participant Assessment of Symptom Intensity at Day 5 Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time. Day 5 No
Secondary Participant Assessment of Symptom Intensity at Day 10 Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time. Day 10 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 NCT01484067 - Study of a Cold Sore Patch for the Treatment of Herpes Labialis N/A
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 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