Topical Steroid Formulation and Wet Wraps

NCT02680301 | Completed Phase 4 Results

• 1 other identifier: CR-16-019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to

1. 1.Compare efficacy of 0.1% triamcinolone containing wet wrap as an ointment or as a cream formulation in patients with moderate to severe atopic dermatitis
2. 2.The relative patient/subject acceptance and adherence will also be compared between the two wet wrap types

Conditions

Dermatitis, Atopic

Keywords

Wet Wraps; Topical Steroid

Outcome Measures

Primary Outcomes (1)

• Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis

  Change in atopic dermatitis based on physician global assessment scale: 0=clear; 1=almost clear; 2=mild disease; 3=moderate disease; 4=severe disease; 5- very severe disease Lower scores represent a better outcome.

  3-5 days

Secondary Outcomes (1)

• Patient Reported Efficacy

  3-5 days

Other Outcomes (1)

• Number of Patients Adhering to Treatment Protocol

  3-5 days

Study Arms (2)

Ointment Right/Cream Left

OTHER

Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on right side and 0.1% triamcinolone CREAM with wet-wrap dressing on left side of bilateral flare of atopic dermatitis twice daily as instructed.

Drug: 0.1% triamcinolone CREAM; Drug: 0.1% triamcinolone OINTMENT

Ointment Left/Cream Right

OTHER

Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on left side and 0.1% triamcinolone CREAM with wet-wrap dressing on right side of bilateral flare of atopic dermatitis twice daily as instructed.

Drug: 0.1% triamcinolone CREAM; Drug: 0.1% triamcinolone OINTMENT

Interventions

0.1% triamcinolone CREAM DRUG

Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.

Also known as: topical steroid cream

Ointment Left/Cream Right; Ointment Right/Cream Left

0.1% triamcinolone OINTMENT DRUG

Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.

Also known as: topical steroid ointment

Ointment Left/Cream Right; Ointment Right/Cream Left

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic dermatitis

You may not qualify if:

• Systemic infection or bacterial skin infections
• Eczema herpeticum
• Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis
• Non-English or Non-Spanish speaking

Sponsors & Collaborators

• Seton Healthcare Family: lead

Study Sites (1)

Specially for Children Dermatology

Austin, Texas, 78723, United States

Location

Related Publications (6)

• Krakowski AC, Eichenfield LF, Dohil MA. Management of atopic dermatitis in the pediatric population. Pediatrics. 2008 Oct;122(4):812-24. doi: 10.1542/peds.2007-2232.

  PMID: 18829806 BACKGROUND

• Janmohamed SR, Oranje AP, Devillers AC, Rizopoulos D, van Praag MC, Van Gysel D, Goeteyn M, de Waard-van der Spek FB. The proactive wet-wrap method with diluted corticosteroids versus emollients in children with atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2014 Jun;70(6):1076-82. doi: 10.1016/j.jaad.2014.01.898. Epub 2014 Mar 31.

  PMID: 24698702 BACKGROUND

• Devillers AC, Oranje AP. Efficacy and safety of 'wet-wrap' dressings as an intervention treatment in children with severe and/or refractory atopic dermatitis: a critical review of the literature. Br J Dermatol. 2006 Apr;154(4):579-85. doi: 10.1111/j.1365-2133.2006.07157.x.

  PMID: 16536797 BACKGROUND

• Bingham LG, Noble JW, Davis MD. Wet dressings used with topical corticosteroids for pruritic dermatoses: A retrospective study. J Am Acad Dermatol. 2009 May;60(5):792-800. doi: 10.1016/j.jaad.2008.12.043.

  PMID: 19389521 BACKGROUND

• Oranje AP, Devillers AC, Kunz B, Jones SL, DeRaeve L, Van Gysel D, de Waard-van der Spek FB, Grimalt R, Torrelo A, Stevens J, Harper J. Treatment of patients with atopic dermatitis using wet-wrap dressings with diluted steroids and/or emollients. An expert panel's opinion and review of the literature. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1277-86. doi: 10.1111/j.1468-3083.2006.01790.x.

  PMID: 17062046 BACKGROUND

• Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004 Dec;140(12):1513-9. doi: 10.1001/archderm.140.12.1513.

  PMID: 15611432 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Katherine Sebastian
• Organization: Seton Family of Hospitals/Ascension

krsebastian@ascension.org

801-598-2484

Study Officials

• Lucia Diaz, MD

  Seton: Dell Children's Medical Center: Specially for Childrens Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 11, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 18, 2019
• Results First Posted: September 13, 2018

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)