Atopic DermatitisPhase 2NCT01469767
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
A Phase 2 study testing Fluocinonide cream in people with Atopic Dermatitis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Fluocinonide cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2012to 17 Aug 2013
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (parent permission and assent if applicable).
- Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
- Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
- Percentage of overall body surface area of involvement (BSA) must be ≥2%.
- Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.
Who cannot join
- Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
- Application or use within two weeks of Baseline topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
- Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
- Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
- Amount of disease involvement that would require >60 gm of cream in a 1 week period.
Show all 9Show fewer
- Subjects with known allergy or sensitivity to topical Vanos® cream or components.
- Pregnant women
- Women who are breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).
Read the detailed description
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.
Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement and Visual Analog Scale for itch. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline.
- Conditions
- Atopic Dermatitis
- Being tested
- Fluocinonide cream
- Keywords
- eczema, itch, scratching, actigraphy, adherence
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinonide creamDrug
Also called Vanos
Fluocinonide cream 0.1% applied twice daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Fluocinonide cream | Experimental | Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Receives: Drug: Fluocinonide cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Measured: 14 days
Secondary outcomes (4)
Actigraphy
Actigraphy Movement Count per Hour:Subjects will be asked to wear an actigraphy monitor on each wrist for the duration of the 14-day study. These monitors appear and function similarly to a wristwatch. The actigraph provides a continuous measure of wrist activity and may be used to quantify nocturnal scratching behavior. A piezoelectric accelerometer records the integration of intensity, amount, and duration of stimuli in all 3 dimensions of wrist movement. Measurements are taken at 32 Hz and a summation value is recorded at the end of each 30-second epoch. The number of 30-second epochs with movement (in which acceleration was detected irrespective of the magnitude of the acceleration) is recorded and summed to give a movement score. This is divided by the duration of time in bed to produce a movement count per hour, which is a sensitive quantitative measure of scratch-associated activity.
Measured: 14 days
EASI
Eczema Area and Severity Index Score:Disease severity will be assessed with the Eczema Area and Severity Index (EASI).This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions and scores erythema, excoriation, induration/papulation, and lichenification. The total are summed for one total EASI score. .The total scores range from 0 (no Eczema) -72 (most severe Eczema)."
Measured: 14 days
BSA
Body Surface Area of atopic dermatitis. The BSA is measured as the total percent of the entire body with atopic dermatitis involved, so the scores range from 0% to 100% of total body involvement.
Measured: 14 days
VAS
Visual Analog Scale for itch: A 100 millimeter (mm) Visual Analog Scale (VAS) will be used to measure itch intensity. VAS is a self-report tool that is designed to present to the respondent a rating scale with minimum constraints. VAS data is recorded as the number of mm from the left of the line with the range 0-100 mm. The Visual Analog Scale is anchored with the verbal descriptions of "no itch" on the left and "the most intense itch imaginable" on the right.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study start1 Feb 2012
- Primary completion17 Aug 2013
- Study completion17 Aug 2013
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.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Medicis Pharmaceutical Corporation
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469767
- Sponsor's protocol ID
- IRB00018876
- Status last verified
- Aug 2018
- First submitted
- 7 Nov 2011
- Last updated
- 7 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01469767
- Acronym / sponsor ID
- IRB00018876
- Conditions
- Atopic Dermatitis
- Keywords
- eczema, itch, scratching, actigraphy, adherence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Medicis Pharmaceutical Corporation
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 17 Aug 2013 (actual)
- Study completion
- 17 Aug 2013 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Posted 1 May 2017
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 assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).
Detailed description
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.
Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement and Visual Analog Scale for itch. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluocinonide cream | Experimental | Drug: Fluocinonide creamSubjects will apply fluocinonide cream 0.1% twice daily for 5 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (parent permission and assent if applicable).
- Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
- Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
- Percentage of overall body surface area of involvement (BSA) must be ≥2%.
- Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.
Key exclusion criteria (9 listed)
- Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
- Application or use within two weeks of Baseline topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
- Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
- Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
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 |
|---|---|---|
| Fluocinonide creamAlso: VanosFluocinonide cream 0.1% applied twice daily for 5 days. | Drug | Fluocinonide cream |
Primary outcome
IGA
Time frame: 14 days
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
4 secondary outcomes
Actigraphy
Time frame: 14 days
EASI
Time frame: 14 days
BSA
Time frame: 14 days
VAS
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluocinonide cream in people with Atopic Dermatitis, run by Wake Forest University 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 5 inclusion and 9 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 7 Sep 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 May 2017). 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?
IGA (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2018.