Clinical trial NCT04258930: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Herpes Zoster
Lead sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of days to achieve complete healing of cutaneous lesions.
timeFrame: Evaluation at 10 days.
measure: Change in pain score using the Zoster Brief Pain Inventory (ZBPI)
timeFrame: Evaluation at baseline, 5 days, 10 days and 40 days.
measure: Pain reduction as per acetaminophen need
timeFrame: Evaluation at 40 days.
measure: Change in the quality of life score as measured by the Dermatology Life Quality Index (DLQI)
timeFrame: Evaluation at baseline, 5 days, 10 days and 40 days.
Secondary outcomes:
measure: Description and quantification of any side effect during the trial.
timeFrame: Evaluation at baseline, 5 days, 10 days and 40 days.
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Hospital General Dr Manuel Gea González
state: DF
Study officials:
affiliation: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
name: Jose Contreras-Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
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