Topical Steroid Formulation and Wet Wraps

May 24, 2019 updated by: Lucia Zoraida Diaz, Seton Healthcare Family

Comparing Efficacy of Topical Steroid Cream vs. Ointment Formulations Using Wet Dressings for Treatment of Atopic Dermatitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
        • Specially for Children Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ointment Right/Cream Left
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
Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
Other Names:
  • topical steroid cream
Drug: 0.1% triamcinolone OINTMENT
Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
Other Names:
  • topical steroid ointment
Other: Ointment Left/Cream Right
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
Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
Other Names:
  • topical steroid cream
Drug: 0.1% triamcinolone OINTMENT
Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
Other Names:
  • topical steroid ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis
Time Frame: 3-5 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Efficacy
Time Frame: 3-5 days
Patient report of which topical steroid formulation was more effective
3-5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Adhering to Treatment Protocol
Time Frame: 3-5 days
Patient-reported adherence to wet-wrap protocol. Medication logs were used to evaluate adherence to the treatment protocol for both steroid formulations. Patents were determined to be adhering to the protocol if the number of wet-wraps for each study arm (cream or ointment) were the same. Because the total number of wraps varied between patients (the protocol required 1-2 wraps per day for 3-5 days), we reviewed medication logs to determine that each patient completed an equivalent number of ointment and cream wraps.
3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seton Healthcare Family

Investigators

  • Principal Investigator: Lucia Diaz, MD, Seton: Dell Children's Medical Center: Specially for Childrens Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-16-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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