Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

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

Status: Unknown

Conditions: Herpes Zoster

Treatments: Device: Hydrocolloid dressing; Device: Topical sterile silicone gel for wounds; Other: Aluminum sulphate and calcium acetate drying soaks

Study type: Interventional

Funder types: Other

Identifiers

NCT04258930

FNEIDAC-HZ-122-19

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Group A: Aluminum sulphate and calcium acetate drying soaks

Active Comparator group

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.

Treatment:

Other: Aluminum sulphate and calcium acetate drying soaks

Group B: Topical sterile silicone gel for wounds

Experimental group

Description:

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

Treatment:

Device: Topical sterile silicone gel for wounds

Group C: Hydrocolloid dressing

Experimental group

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.

Treatment:

Device: Hydrocolloid dressing