Topical Steroid Formulation and Wet Wraps
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): 0.1% triamcinolone CREAM; 0.1% triamcinolone OINTMENT
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.; Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
Other intervention name(s): topical steroid cream; topical steroid ointment
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Wet Wraps; Topical Steroid