Occlusion vs Standard Treatment for the Treatment of Herpes Zoster

NCT04258930 | Unknown

• 1 other identifier: FNEIDAC-HZ-122-19
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Description and quantification of any side effect during the trial.

  Evaluation at baseline, 5 days, 10 days and 40 days.

Study Arms (3)

Group A: Aluminum sulphate and calcium acetate drying soaks

ACTIVE COMPARATOR

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.

Other: Aluminum sulphate and calcium acetate drying soaks

Group B: Topical sterile silicone gel for wounds

EXPERIMENTAL

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

Device: Topical sterile silicone gel for wounds

Group C: Hydrocolloid dressing

EXPERIMENTAL

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.

Device: Hydrocolloid dressing

Interventions

Aluminum sulphate and calcium acetate drying soaks OTHER

Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.

Also known as: Domeboro

Group A: Aluminum sulphate and calcium acetate drying soaks

Topical sterile silicone gel for wounds DEVICE

Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.

Also known as: Stratamed gel

Group B: Topical sterile silicone gel for wounds

Hydrocolloid dressing DEVICE

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).

Also known as: Duoderm Extra-thin

Group C: Hydrocolloid dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital General Dr Manuel Gea González

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (19)

• 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. doi: 10.1155/2010/178036.

  PMID: 21358885 BACKGROUND

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

  PMID: 24113666 BACKGROUND

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

  PMID: 23863052 BACKGROUND

• 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. doi: 10.1016/j.jpain.2004.06.001.

  PMID: 15336639 BACKGROUND

• 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. doi: 10.1111/j.1365-2230.1994.tb01167.x.

  PMID: 8033378 BACKGROUND

• 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. No abstract available.

  PMID: 22138810 BACKGROUND

• HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.

  PMID: 14087904 BACKGROUND

• 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.

  PMID: 18462303 BACKGROUND

• 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.

  PMID: 25907451 BACKGROUND

• 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.

  PMID: 18675742 BACKGROUND

• 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. No abstract available.

  PMID: 24267314 BACKGROUND

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

  PMID: 24030657 BACKGROUND

• 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. doi: 10.1097/01.ASW.0000280199.58260.62.

  PMID: 17620742 BACKGROUND

• 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.

  PMID: 19126048 BACKGROUND

• 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. doi: 10.1590/0104-1169.3480.2445.

  PMID: 25029065 BACKGROUND

• 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.

  PMID: 25209019 BACKGROUND

• 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. No abstract available.

  PMID: 26341747 BACKGROUND

• 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. doi: 10.1038/193293a0. No abstract available.

  PMID: 14007593 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Herpes Zoster

Interventions

Aluminum Hydroxide; aluminum acetate; Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes; Bandages; Equipment and Supplies

Study Officials

• Jose Contreras-Ruiz, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Contreras-Ruiz, MD

CONTACT

+525540003000; dermayheridas@gmail.com

Adriana Lozano-Platonoff, MD

CONTACT

+525540003000; dralozanoplatonoff@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 6, 2020
• Study Start: February 26, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

ME (1)