Dermatitis, Atopic
Conditions
Keywords
Wet Wraps, Topical Steroid
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.
Interventions
DRUG0.1% triamcinolone CREAM
Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
DRUG0.1% triamcinolone OINTMENT
Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
Sponsors
Seton Healthcare Family
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Efficacy | 3-5 days | Patient report of which topical steroid formulation was more effective |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Adhering to Treatment Protocol | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 22 |
| 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.
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.
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. | 17 |
| Total | 39 |
Baseline characteristics
| Characteristic | Ointment Right/Cream Left | Ointment Left/Cream Right | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 17 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.14 years STANDARD_DEVIATION 3.88 | 7.29 years STANDARD_DEVIATION 3.27 | 7.77 years STANDARD_DEVIATION 3.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 9 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 8 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 24 Participants |
| Region of Enrollment United States | 22 participants | 17 participants | 39 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
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.
Time frame: 3-5 days
Population: Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cream | Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis | 0.717 units on a scale | Standard Deviation 0.65 |
| Ointment | Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis | 0.589 units on a scale | Standard Deviation 0.64 |
p-value: 0.22Wilcoxon (Mann-Whitney)
Secondary
Patient Reported Efficacy
Patient report of which topical steroid formulation was more effective
Time frame: 3-5 days
Population: Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cream | Patient Reported Efficacy | Cream | 9 Participants |
| Cream | Patient Reported Efficacy | No Difference | 14 Participants |
| Cream | Patient Reported Efficacy | Ointment | 16 Participants |
Other Pre-specified
Number of Patients Adhering to Treatment Protocol
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.
Time frame: 3-5 days
Population: Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cream | Number of Patients Adhering to Treatment Protocol | 39 Participants |