Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

Herpes Zoster Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04258930
• Other study ID #: FNEIDAC-HZ-122-19
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2020
• Source: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
• Contact: Jose Contreras-Ruiz, MD
• Phone: +525540003000
• Email: dermayheridas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Other:
• Aluminum sulphate and calcium acetate drying soaks
Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.

Device:
• Topical sterile silicone gel for wounds
Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
• Hydrocolloid dressing
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).

Locations

Country	Name	City	State
Mexico	Hospital General Dr Manuel Gea González	Mexico	DF

Sponsors (1)

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

Country where clinical trial is conducted

Mexico, 

References & Publications (19)

Bader MS. Herpes zoster: diagnostic, therapeutic, and preventive approaches. Postgrad Med. 2013 Sep;125(5):78-91. doi: 10.3810/pgm.2013.09.2703. Review. — View Citation

Boivin G, Jovey R, Elliott CT, Patrick DM. Management and prevention of herpes zoster: A Canadian perspective. Can J Infect Dis Med Microbiol. 2010 Spring;21(1):45-52. — View Citation

Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674. Review. — View Citation

Coplan PM, Schmader K, Nikas A, Chan IS, Choo P, Levin MJ, Johnson G, Bauer M, Williams HM, Kaplan KM, Guess HA, Oxman MN. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain. 2004 Aug;5(6):344-56. — View Citation

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. — View Citation

Greenwood JE, Wagstaff MJ, Mackie IP, Mustoe TA. Silicone action in the open wound: a hypothesis. J Burn Care Res. 2012 Jan-Feb;33(1):e17-20. doi: 10.1097/BCR.0b013e31823e68cc. — View Citation

HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. — View Citation

Karlsmark T, Goodman JJ, Drouault Y, Lufrano L, Pledger GW; Cold Sore Study Group. Randomized clinical study comparing Compeed cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis. J Eur Acad Dermatol Venereol. 2008 Nov;22(10):1184-92. doi: 10.1111/j.1468-3083.2008.02761.x. Epub 2008 May 6. — View Citation

Keegan DA. Reducing pain in acute herpes zoster with plain occlusive dressings: a case report. J Med Case Rep. 2015 Apr 25;9:89. doi: 10.1186/s13256-015-0560-5. — View Citation

Lin PL, Fan SZ, Huang CH, Huang HH, Tsai MC, Lin CJ, Sun WZ. Analgesic effect of lidocaine patch 5% in the treatment of acute herpes zoster: a double-blind and vehicle-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):320-5. doi: 10.1016/j.rapm.2007.02.015. — View Citation

Monk EC, Benedetto EA, Benedetto AV. Successful treatment of nonhealing scalp wounds using a silicone gel. Dermatol Surg. 2014 Jan;40(1):76-9. doi: 10.1111/dsu.12366. Epub 2013 Nov 25. — View Citation

O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;(9):CD003826. doi: 10.1002/14651858.CD003826.pub3. Review. — View Citation

Patel AR, Romanelli P, Roberts B, Kirsner RS. Herpes simplex virus: a histopathologic study of the depth of herpetic wounds. Int J Dermatol. 2009 Jan;48(1):36-40. doi: 10.1111/j.1365-4632.2009.03788.x. — View Citation

Patel AR, Romanelli P, Roberts B, Kirsner RS. Treatment of herpes simplex virus infection: rationale for occlusion. Adv Skin Wound Care. 2007 Jul;20(7):408-12. Review. — View Citation

Pott FS, Meier MJ, Stocco JG, Crozeta K, Ribas JD. The effectiveness of hydrocolloid dressings versus other dressings in the healing of pressure ulcers in adults and older adults: a systematic review and meta-analysis. Rev Lat Am Enfermagem. 2014 May-Jun;22(3):511-20. Review. English, Portuguese, Spanish. — View Citation

Strauss SE, Oxman NM. Varicella and Herpes Zoster. In: Freedberg IM, Eisen AZ, Wolff K, Kopff A, et al. editors. Fitzpatrick´s dermatology in general medicine. New York, McGraw-Hill 1999, pp 2427-49.

Tsai TF, Yao CA, Yu HS, Lan CC, Chao SC, Yang JH, Yang KC, Chen CY, White RR, Psaradellis E, Rampakakis E, Kawai K, Acosta CJ, Sampalis JS. Herpes zoster-associated severity and duration of pain, health-related quality of life, and healthcare utilization in Taiwan: a prospective observational study. Int J Dermatol. 2015;54(5):529-36. doi: 10.1111/ijd.12484. Epub 2014 Sep 10. — View Citation

Uva L, Aphale AN, Kehdy J, Benedetto AV. Erosive pustular dermatosis successfully treated with a novel silicone gel. Int J Dermatol. 2016 Jan;55(1):89-91. doi: 10.1111/ijd.13066. Epub 2015 Sep 4. — View Citation

WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.