Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

Not Applicable

• Conditions: Herpes Zoster
• Interventions: Other: Aluminum sulphate and calcium acetate drying soaks; Device: Topical sterile silicone gel for wounds; Device: Hydrocolloid dressing

• Registration Number: NCT04258930
• Lead Sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-02-26
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Aluminum sulphate and calcium acetate drying soaks	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.
Group B: Topical sterile silicone gel for wounds	Topical sterile silicone gel for wounds	Group B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours.
Group C: Hydrocolloid dressing	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.

Primary Outcome Measures

Name	Time	Method
Change in pain score using the Zoster Brief Pain Inventory (ZBPI)	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.
Number of days to achieve complete healing of cutaneous lesions.	Evaluation at 10 days.	The total number of days from the beginning of the rash to the disappearance of all scabs.
Pain reduction as per acetaminophen need	Evaluation at 40 days.	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)	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Dr Manuel Gea González; 🇲🇽 Mexico, DF, Mexico