Topical Steroid Formulation and Wet Wraps
| Status: | Completed |
|---|---|
| Conditions: | Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 9/15/2018 |
| Start Date: | March 2016 |
| End Date: | June 1, 2018 |
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
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
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.
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.
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
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