Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Herpes Zoster

Intervention / Treatment
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* Other: Aluminum sulphate and calcium acetate drying soaks
* Device: Topical sterile silicone gel for wounds
* Device: Hydrocolloid dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Aluminum sulphate and calcium acetate drying soaks<br>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<br>* Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.<br>* Other names: Domeboro;|
| Experimental: Group B: Topical sterile silicone gel for wounds<br>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<br>* Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.<br>* Other names: Stratamed gel;|
| Experimental: Group C: Hydrocolloid dressing<br>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<br>* 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).<br>* Other names: Duoderm Extra-thin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Evaluation at 10 days. | 
| 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. | Evaluation at baseline, 5 days, 10 days and 40 days. | 
| Pain reduction as per acetaminophen need | 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) | 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. | Presence or absence of side effects of any of the above treatments. | Evaluation at baseline, 5 days, 10 days and 40 days. |