Dermatitis, AtopicPhase 4NCT02680301
Topical Steroid Formulation and Wet Wraps
A Phase 4 study testing 0.1% triamcinolone CREAM and 0.1% triamcinolone OINTMENT in people with Dermatitis, Atopic, run by Seton Healthcare Family at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- 0.1% triamcinolone CREAM and 0.1% triamcinolone OINTMENT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic dermatitis
- The flares must reach a certain threshold for inclusion based on the investigator's global assessment scale
Who cannot join
- Systemic infection or bacterial skin infections
- Eczema herpeticum
- Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis
- Non-English or Non-Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Specially for Children Dermatology
Austin, Texas, 78723
About this study
Official title: Comparing Efficacy of Topical Steroid Cream vs. Ointment Formulations Using Wet Dressings for Treatment of Atopic Dermatitis
The purpose of this study is to
- 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
- The relative patient/subject acceptance and adherence will also be compared between the two wet wrap types
Read the 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- 0.1% triamcinolone CREAM, 0.1% triamcinolone OINTMENT
- Keywords
- Wet Wraps, Topical Steroid
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% triamcinolone CREAMDrug
Also called topical steroid 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 OINTMENTDrug
Also called topical steroid ointment
Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
| Study group | Role | What they receive |
|---|---|---|
| Ointment Right/Cream Left | Other | 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. Receives: Drug: 0.1% triamcinolone CREAM; Drug: 0.1% triamcinolone OINTMENT |
| Ointment Left/Cream Right | Other | 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. Receives: Drug: 0.1% triamcinolone CREAM; Drug: 0.1% triamcinolone OINTMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-5 days
Secondary outcomes (1)
Patient Reported Efficacy
Patient report of which topical steroid formulation was more effective
Measured: 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Zoraida Diaz, Seton Healthcare Family
- Investigators
- Lucia Diaz, MD, Principal investigator, Seton: Dell Children's Medical Center: Specially for Childrens Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680301
- Sponsor's protocol ID
- CR-16-019
- Status last verified
- May 2019
- First submitted
- 2 Feb 2016
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Krakowski AC, Eichenfield LF, Dohil MA. Management of atopic dermatitis in the pediatric population. Pediatrics. 2008 Oct;122(4):812-24. doi: 10.1542/peds.2007-2232.
PubMed 18829806Janmohamed SR, Oranje AP, Devillers AC, Rizopoulos D, van Praag MC, Van Gysel D, Goeteyn M, de Waard-van der Spek FB. The proactive wet-wrap method with diluted corticosteroids versus emollients in children with atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2014 Jun;70(6):1076-82. doi: 10.1016/j.jaad.2014.01.898. Epub 2014 Mar 31.
PubMed 24698702Devillers AC, Oranje AP. Efficacy and safety of 'wet-wrap' dressings as an intervention treatment in children with severe and/or refractory atopic dermatitis: a critical review of the literature. Br J Dermatol. 2006 Apr;154(4):579-85. doi: 10.1111/j.1365-2133.2006.07157.x.
PubMed 16536797Bingham LG, Noble JW, Davis MD. Wet dressings used with topical corticosteroids for pruritic dermatoses: A retrospective study. J Am Acad Dermatol. 2009 May;60(5):792-800. doi: 10.1016/j.jaad.2008.12.043.
PubMed 19389521Oranje AP, Devillers AC, Kunz B, Jones SL, DeRaeve L, Van Gysel D, de Waard-van der Spek FB, Grimalt R, Torrelo A, Stevens J, Harper J. Treatment of patients with atopic dermatitis using wet-wrap dressings with diluted steroids and/or emollients. An expert panel's opinion and review of the literature. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1277-86. doi: 10.1111/j.1468-3083.2006.01790.x.
PubMed 17062046Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004 Dec;140(12):1513-9. doi: 10.1001/archderm.140.12.1513.
PubMed 15611432
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Topical Steroid Cream vs. Ointment Formulations Using Wet Dressings for Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02680301
- Acronym / sponsor ID
- CR-16-019
- Conditions
- Dermatitis, Atopic
- Keywords
- Wet Wraps, Topical Steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ointment Right/Cream Left | Other | Drug: 0.1% triamcinolone CREAM, Drug: 0.1% triamcinolone OINTMENTPt. 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. |
| Ointment Left/Cream Right | Other | Drug: 0.1% triamcinolone CREAM, Drug: 0.1% triamcinolone OINTMENTPt. 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic dermatitis
- The flares must reach a certain threshold for inclusion based on the investigator's global assessment scale
Key exclusion criteria (4 listed)
- Systemic infection or bacterial skin infections
- Eczema herpeticum
- Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis
- Non-English or Non-Spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% triamcinolone CREAMAlso: topical steroid creamPatients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique. | Drug | Ointment Left/Cream Right, Ointment Right/Cream Left |
| 0.1% triamcinolone OINTMENTAlso: topical steroid ointmentPatients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique. | Drug | Ointment Left/Cream Right, Ointment Right/Cream Left |
Primary outcome
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.
1 secondary outcome
Patient Reported Efficacy
Time frame: 3-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18829806Krakowski AC, Eichenfield LF, Dohil MA. Management of atopic dermatitis in the pediatric population. Pediatrics. 2008 Oct;122(4):812-24. doi: 10.1542/peds.2007-2232.
- Background: PubMed 24698702Janmohamed SR, Oranje AP, Devillers AC, Rizopoulos D, van Praag MC, Van Gysel D, Goeteyn M, de Waard-van der Spek FB. The proactive wet-wrap method with diluted corticosteroids versus emollients in children with atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2014 Jun;70(6):1076-82. doi: 10.1016/j.jaad.2014.01.898. Epub 2014 Mar 31.
- Background: PubMed 16536797Devillers AC, Oranje AP. Efficacy and safety of 'wet-wrap' dressings as an intervention treatment in children with severe and/or refractory atopic dermatitis: a critical review of the literature. Br J Dermatol. 2006 Apr;154(4):579-85. doi: 10.1111/j.1365-2133.2006.07157.x.
- Background: PubMed 19389521Bingham LG, Noble JW, Davis MD. Wet dressings used with topical corticosteroids for pruritic dermatoses: A retrospective study. J Am Acad Dermatol. 2009 May;60(5):792-800. doi: 10.1016/j.jaad.2008.12.043.
- Background: PubMed 17062046Oranje AP, Devillers AC, Kunz B, Jones SL, DeRaeve L, Van Gysel D, de Waard-van der Spek FB, Grimalt R, Torrelo A, Stevens J, Harper J. Treatment of patients with atopic dermatitis using wet-wrap dressings with diluted steroids and/or emollients. An expert panel's opinion and review of the literature. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1277-86. doi: 10.1111/j.1468-3083.2006.01790.x.
- Background: PubMed 15611432Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004 Dec;140(12):1513-9. doi: 10.1001/archderm.140.12.1513.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Diaz, MD principal investigator
Seton: Dell Children's Medical Center: Specially for Childrens Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.1% triamcinolone CREAM and 0.1% triamcinolone OINTMENT in people with Dermatitis, Atopic, run by Seton Healthcare Family at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680301, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.