Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

February 26, 2020 updated by: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

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.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico, DF, Mexico, 14080
        • Recruiting
        • Hospital General Dr Manuel Gea Gonzalez
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Aluminum sulphate and calcium acetate drying soaks
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.
Other: Aluminum sulphate and calcium acetate drying soaks
Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.
Other Names:
  • Domeboro
Experimental: Group B: Topical sterile silicone gel for wounds
Group B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours.
Device: Topical sterile silicone gel for wounds
Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
Other Names:
  • Stratamed gel
Experimental: Group C: Hydrocolloid dressing
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.
Device: Hydrocolloid dressing
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).
Other Names:
  • Duoderm Extra-thin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days to achieve complete healing of cutaneous lesions.
Time Frame: Evaluation at 10 days.
The total number of days from the beginning of the rash to the disappearance of all scabs.
Evaluation at 10 days.
Change in pain score using the Zoster Brief Pain Inventory (ZBPI)
Time Frame: Evaluation at baseline, 5 days, 10 days and 40 days.
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.
Evaluation at baseline, 5 days, 10 days and 40 days.
Pain reduction as per acetaminophen need
Time Frame: Evaluation at 40 days.
Amount of acetaminophen taken in total for pain control through the duration of the trial.
Evaluation at 40 days.
Change in the quality of life score as measured by the Dermatology Life Quality Index (DLQI)
Time Frame: Evaluation at baseline, 5 days, 10 days and 40 days.
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).
Evaluation at baseline, 5 days, 10 days and 40 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description and quantification of any side effect during the trial.
Time Frame: Evaluation at baseline, 5 days, 10 days and 40 days.
Presence or absence of side effects of any of the above treatments.
Evaluation at baseline, 5 days, 10 days and 40 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

Investigators

  • Principal Investigator: Jose Contreras-Ruiz, MD, Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2020

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNEIDAC-HZ-122-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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