Topical Steroid Formulation and Wet Wraps

Seton Healthcare Family

Status and phase: Completed; Phase 4

Conditions: Dermatitis, Atopic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02680301

CR-16-019

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Ointment Right/Cream Left

Other group

Description:

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.

Treatment:

Drug: 0.1% triamcinolone CREAM

Drug: 0.1% triamcinolone OINTMENT

Ointment Left/Cream Right

Other group

Description:

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.

Treatment:

Drug: 0.1% triamcinolone CREAM

Drug: 0.1% triamcinolone OINTMENT