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Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

Primary Purpose

Herpes Zoster

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Aluminum sulphate and calcium acetate drying soaks
Topical sterile silicone gel for wounds
Hydrocolloid dressing
Sponsored by
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with clinical diagnosis of HZ confirmed by a certified dermatologist
  • Patients having maximum 72 hours from the start of the first vesicle
  • Older than 18 years

Exclusion Criteria:

  • Patients with dimethicone allergy
  • Patients with hydrocolloid allergy
  • Patients with acetaminophen allergy
  • Patients with aluminium sulphate and calcium acetate allergy
  • Patients with acyclovir allergy
  • Pregnant women
  • Breastfeeding women
  • Unable to give informed consent
  • Patients with signs of infection over the skin rash
  • Patients with disseminated HZ
  • Patients with hemorrhagic HZ
  • Patients with complications such as pneumonia or encephalitis
  • Patients unable to apply the treatment to the affected area
  • Patients with HZ-associated keratitis
  • Patients whose rash is located to hairy areas that may hinder occlusion with the hydrocolloid dressing.

Sites / Locations

  • Hospital General Dr Manuel Gea GonzálezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group A: Aluminum sulphate and calcium acetate drying soaks

Group B: Topical sterile silicone gel for wounds

Group C: Hydrocolloid dressing

Arm Description

Group A will receive 10 minute soaks every 8 hours with a solution prepared with aluminum sulphate and calcium acetate powder (Domeboro® (Advaita Pharmaceuticals, México)) diluted in 500 ml of clean cold water.

Group B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours.

Group C will apply an extra thin hydrocolloid dressing to all the open areas (Duoderm Extra Thin® (Convatec, USA)) with dressing changes every 48 to 72 hours depending on the amount of wound exudate.

Outcomes

Primary Outcome Measures

Number of days to achieve complete healing of cutaneous lesions.
The total number of days from the beginning of the rash to the disappearance of all scabs.
Change in pain score using the Zoster Brief Pain Inventory (ZBPI)
Score reduction in the Zoster Brief Pain Inventory (ZBPI). It uses an 11-point Likert scale (0-10) to rate herpes zoster pain and discomfort for four different dimensions (worst, least, and average during the past 24 hours, and now) and herpes zoster pain and discomfort-related interference with seven items of activities of daily living and health: general activity, mood, walking ability, work, relations with others, sleep, enjoyment of life.
Pain reduction as per acetaminophen need
Amount of acetaminophen taken in total for pain control through the duration of the trial.
Change in the quality of life score as measured by the Dermatology Life Quality Index (DLQI)
Quality of life score improvement as measured by the Dermatology Life Quality Index (DLQI). There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).

Secondary Outcome Measures

Description and quantification of any side effect during the trial.
Presence or absence of side effects of any of the above treatments.

Full Information

First Posted
January 15, 2020
Last Updated
February 26, 2020
Sponsor
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
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1. Study Identification

Unique Protocol Identification Number
NCT04258930
Brief Title
Occlusion vs Standard Treatment for the Treatment of Herpes Zoster
Official Title
Randomized Comparative Open Trial of Occlusive Therapy With a Hydrocolloid or Silicone Versus Conventional Drying Treatment for the Local Care of Acute Lesions Caused by Herpes Zoster.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the addition of occlusive dressings (hydrocolloids) or topical silicone gel in the treatment of shingles (herpes zoster). One third of the participants will receive a hydrocolloid occlusive dressing, one third will receive the topical silicone gel and one third will receive the current treatment of the rash consisting of drying solutions (soaks).
Detailed Description
Herpes zoster (HZ), also known shingles, is a viral disease caused by the varicella-zoster virus. It is considered a local reactivation of varicella (chicken pox). The rash of herpes zoster is characterized by vesicles that appear following a single dermatome (the territory that is innervated by one spinal nerve). These vesicles may be very painful and cause discomfort due to draining and crusting. When a person becomes sick with shingles healthcare professionals prescribe systemic (oral) treatment with antivirals (e.g. acyclovir) and pain medication according to the type and severity. To treat the local lesions caused by shingles, over the centuries, patients have been treated with drying solutions and drying powders. This practice has been passed on through the years without any evidence supporting its effectiveness, in all likelihood due to the fact that the rash is self-limited to 2 to 3 weeks. Recently, new evidence has shown that the vesicles that appear with the shingles rash are not superficial but involve deeper areas of the skin and should be considered partial thickness wounds. Since 1962, it has become clear that partial thickness wounds benefit from occlusive therapy (keeping wounds closed and avoiding drying) such as dressings and occlusive gels that keep the wound wet rather than allowing it to dry. In this clinical trial the investigators believe that given this information, using occlusive therapy with a hydrocolloid dressing or a silicone-based gel may heal the rash of herpes zoster, decrease pain and improve the quality of life, much faster than the treatment currently used of drying the area with powders and solutions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized comparative open trial comparing occlusive therapy with hydrocolloid dressings versus a silicone gel vs a drying solution (standard care) to treat the rash of herpes zoster.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Aluminum sulphate and calcium acetate drying soaks
Arm Type
Active Comparator
Arm Description
Group A will receive 10 minute soaks every 8 hours with a solution prepared with aluminum sulphate and calcium acetate powder (Domeboro® (Advaita Pharmaceuticals, México)) diluted in 500 ml of clean cold water.
Arm Title
Group B: Topical sterile silicone gel for wounds
Arm Type
Experimental
Arm Description
Group B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours.
Arm Title
Group C: Hydrocolloid dressing
Arm Type
Experimental
Arm Description
Group C will apply an extra thin hydrocolloid dressing to all the open areas (Duoderm Extra Thin® (Convatec, USA)) with dressing changes every 48 to 72 hours depending on the amount of wound exudate.
Intervention Type
Other
Intervention Name(s)
Aluminum sulphate and calcium acetate drying soaks
Other Intervention Name(s)
Domeboro
Intervention Description
Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.
Intervention Type
Device
Intervention Name(s)
Topical sterile silicone gel for wounds
Other Intervention Name(s)
Stratamed gel
Intervention Description
Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
Intervention Type
Device
Intervention Name(s)
Hydrocolloid dressing
Other Intervention Name(s)
Duoderm Extra-thin
Intervention Description
Apply enough hydrocolloid dressings to cover all open areas and change every 2 to 3 days once the dressing becomes saturated (starts to drain around the borders).
Primary Outcome Measure Information:
Title
Number of days to achieve complete healing of cutaneous lesions.
Description
The total number of days from the beginning of the rash to the disappearance of all scabs.
Time Frame
Evaluation at 10 days.
Title
Change in pain score using the Zoster Brief Pain Inventory (ZBPI)
Description
Score reduction in the Zoster Brief Pain Inventory (ZBPI). It uses an 11-point Likert scale (0-10) to rate herpes zoster pain and discomfort for four different dimensions (worst, least, and average during the past 24 hours, and now) and herpes zoster pain and discomfort-related interference with seven items of activities of daily living and health: general activity, mood, walking ability, work, relations with others, sleep, enjoyment of life.
Time Frame
Evaluation at baseline, 5 days, 10 days and 40 days.
Title
Pain reduction as per acetaminophen need
Description
Amount of acetaminophen taken in total for pain control through the duration of the trial.
Time Frame
Evaluation at 40 days.
Title
Change in the quality of life score as measured by the Dermatology Life Quality Index (DLQI)
Description
Quality of life score improvement as measured by the Dermatology Life Quality Index (DLQI). There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time Frame
Evaluation at baseline, 5 days, 10 days and 40 days.
Secondary Outcome Measure Information:
Title
Description and quantification of any side effect during the trial.
Description
Presence or absence of side effects of any of the above treatments.
Time Frame
Evaluation at baseline, 5 days, 10 days and 40 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with clinical diagnosis of HZ confirmed by a certified dermatologist Patients having maximum 72 hours from the start of the first vesicle Older than 18 years Exclusion Criteria: Patients with dimethicone allergy Patients with hydrocolloid allergy Patients with acetaminophen allergy Patients with aluminium sulphate and calcium acetate allergy Patients with acyclovir allergy Pregnant women Breastfeeding women Unable to give informed consent Patients with signs of infection over the skin rash Patients with disseminated HZ Patients with hemorrhagic HZ Patients with complications such as pneumonia or encephalitis Patients unable to apply the treatment to the affected area Patients with HZ-associated keratitis Patients whose rash is located to hairy areas that may hinder occlusion with the hydrocolloid dressing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Contreras-Ruiz, MD
Phone
+525540003000
Ext
6704
Email
dermayheridas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Lozano-Platonoff, MD
Phone
+525540003000
Ext
6704
Email
dralozanoplatonoff@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Contreras-Ruiz, MD
Organizational Affiliation
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Dr Manuel Gea González
City
Mexico
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Contreras-Ruiz, MD
Phone
+525540003000
Ext
6704
Email
dermayheridas@gmail.com
First Name & Middle Initial & Last Name & Degree
Adriana Lozano-Platonoff, MD
Phone
+525540003000
Ext
6704
Email
dralozanoplatonoff@gmail.com

12. IPD Sharing Statement

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Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

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