Atopic DermatitisPhase 4VanosNCT01049243
A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
A Phase 4 study testing Fluocinonide Cream 0.1% in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days. 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 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2009
- 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 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 (and assent if applicable)
- Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))
- Percentage of overall body surface are of involvement (BSA) must be ≥2%
- Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control
Who cannot join
- Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
- Application or use within 2 weeks of baseline of 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
- Amount of disease involvement that would require >60 gm of cream in a 1 week period
- Subjects with known allergy or sensitivity to topical Vanos™ cream or components
- Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
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
Official title: An Open-Label Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.
Read the detailed description
This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.
- Conditions
- Atopic Dermatitis
- Being tested
- Fluocinonide Cream 0.1%
- Keywords
- Atopic Dermatitis, Open-Label, Topical, Cream, Eczema, Vanos
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinonide Cream 0.1%Drug
Also called Vanos
0.1% Cream, One Application, Twice Daily, 14 Days
| Study group | Role | What they receive |
|---|---|---|
| Fluocinonide Cream 0.1% | Other | Fluocinonide Cream 0.1% open label Receives: Drug: Fluocinonide Cream 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Measured: Baseline to 3 days
Secondary outcomes (1)
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Measured: Baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionOct 2009
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medicis Pharmaceutical Corporation
- Responsible party
- Sponsor
- Investigators
- Steven Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049243
- Sponsor's protocol ID
- IRB00006468
- Acronym
- Vanos
- Status last verified
- Jul 2018
- First submitted
- 12 Jan 2010
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01049243
- Acronym / sponsor ID
- Vanos / IRB00006468
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Open-Label, Topical, Cream, Eczema, Vanos
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medicis Pharmaceutical Corporation
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Posted 5 Mar 2013
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 research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.
Detailed description
This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.
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 0.1% | Other | Drug: Fluocinonide Cream 0.1%Fluocinonide Cream 0.1% open label |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (and assent if applicable)
- Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))
- Percentage of overall body surface are of involvement (BSA) must be ≥2%
- Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control
Key exclusion criteria (7 listed)
- Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
- Application or use within 2 weeks of baseline of 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
- Amount of disease involvement that would require >60 gm of cream in a 1 week period
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 Cream 0.1%Also: Vanos0.1% Cream, One Application, Twice Daily, 14 Days | Drug | Fluocinonide Cream 0.1% |
Primary outcome
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
Time frame: Baseline to 3 days
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
1 secondary outcome
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.
Time frame: Baseline to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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 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 4 study testing Fluocinonide Cream 0.1% in people with Atopic Dermatitis, run by Wake Forest University Health Sciences 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 4 inclusion and 7 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 1 Aug 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 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 5 Mar 2013). 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?
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3. (time frame: Baseline to 3 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 1 Aug 2018.