Clinical trial NCT02680301: Topical Steroid Formulation and Wet Wraps
Official title: Comparing Efficacy of Topical Steroid Cream vs. Ointment Formulations Using Wet Dressings for Treatment of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Wet Wraps
Topical Steroid
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to

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. The relative patient/subject acceptance and adherence will also be compared between the two wet wrap types

Detailed description: In this study, the investigators will examine the effectiveness of wet wraps with topical steroids in different formulations for patients with a history of atopic dermatitis who are experiencing an acute flare. A validated clinical tool such Investigator's Global Assessment (IGA) will be used in order to assess severity of the condition as well as demonstrate the appropriateness of using wet wrap therapy as a treatment modality. IGA will measure intensity of the atopic dermatitis regarding erythema, lichenification, swelling and excoriation as well as subjective symptoms of the patient on a numeric scale. The treating clinician will be asked to rate their assessment before and after therapy.

Patients will be asked to apply a topical steroid in a cream formulation to one extremity and then apply the same topical steroid in an ointment formulation to the other using the wet wrap technique. One of the investigators or nursing staff will provide detailed instructions to the patient and parents on how to perform the wet dressing (this is already routinely done for patients initiating wet wrap therapy in the pediatric dermatology clinic). Patients will also be given a sealed and coded envelope containing instructions to apply one steroid formulation to the right extremity and the other to the left. In this manner the providers will be blinded to treatment modality during the follow-up visit. Only the research coordinator will have access to the envelope code key. An additional handout will also be provided to reinforce appropriate treatment technique. After several days (3-5) the patient will return to the dermatology clinic for a nurse visit and evaluation of any improvement of the affected areas as well as comparison of improvement of the right and left extremities. The physician investigator will examine the patient and measure improvement using the IGA. Detailed photos of the affected areas will also be taken. After a certain number of patients have enrolled in the study and completed it, the de-identified data will be examined by a statistician for comparison. Other studies evaluating the effectiveness of wet wraps have commonly had 40-50 patients enrolled which will likely be the target of this study. The statistician will compare the IGA before and after treatment on each side to allow for interpretation of the data. Stratification of data may include ages and/or severity (moderate vs severe).

Patient Oriented Eczema Measure (POEM) and/or a Quality of Life (QoL) index will also be provided to determine the patient's point of view regarding their management using validated tools. They will also be asked their opinion regarding if one side was better controlled than the other, if at all, as well as their personal preference for treatment of choice.

Compliance will be determined by weighing the medication before and after each visit and a medication calendar.

Eligibility criteria: Inclusion Criteria:

1. Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic dermatitis
2. The flares must reach a certain threshold for inclusion based on the investigator's global assessment scale

Exclusion Criteria:

1. Systemic infection or bacterial skin infections
2. Eczema herpeticum
3. Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis
4. Non-English or Non-Spanish speaking

Primary outcomes:
measure: Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis
timeFrame: 3-5 days
Secondary outcomes:
measure: Patient Reported Efficacy
timeFrame: 3-5 days
Other outcomes:
measure: Number of Patients Adhering to Treatment Protocol
timeFrame: 3-5 days
Locations:
city: Austin
country: United States
facility: Specially for Children Dermatology
state: Texas
Study officials:
affiliation: Seton: Dell Children's Medical Center: Specially for Childrens Dermatology
name: Lucia Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.