Viewing Study NCT04258930



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Last Modification Date: 2024-10-26 @ 1:27 PM
Study NCT ID: NCT04258930
Status: UNKNOWN
Last Update Posted: 2020-02-28
First Post: 2020-01-15

Brief Title: Occlusion vs Standard Treatment for the Treatment of Herpes Zoster
Sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología AC
Organization: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología AC

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2020-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None