Atopic DermatitisNCT00886587
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
A study testing F# 11054-010 and F# 10495-053 in people with Atopic Dermatitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.
Trial summary
The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- F# 11054-010 and F# 10495-053
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Jun 2009
- Phase
- Interventional
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Post-menarchal female subjects must have a negative urine pregnancy test
- Willing to provide written informed consent/assent
- Diagnosed as having mild to moderate Atopic Dermatitis (AD)
- Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
- Willing to replace their body wash and/or soaps with the one provided in this trial
Who cannot join
- Severe AD as determined by the Rajka-Langeland Severity Index
- AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
- History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
- Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
- Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Thomas J. Stephens & Associates, Inc
Colorado Springs, Colorado, 80915
About this study
Official title: A Double-Blind, Randomized, Active-Controlled Clinical Trial To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.
Read the detailed description
This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J\&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of the study.
- Conditions
- Atopic Dermatitis
- Being tested
- F# 11054-010, F# 10495-053
- Keywords
- eczema
- 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.
F# 11054-010Device
Also called Investigational Device
Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
F# 10495-053Device
Also called Atopiclair® Skin and Wound Emulsion
Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
| Study group | Role | What they receive |
|---|---|---|
| 11054-010 | Experimental | F# 11054-010 Investigational Device Receives: Device: F# 11054-010 |
| 10495-053 | Active comparator | F# 10495-053 Atopiclair Receives: Device: F# 10495-053 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
Measured: Baseline to Day 43
Secondary outcomes (3)
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
Measured: Baseline to Day 15
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).
Measured: Baseline to Day 43
Itch Score on Day 43 - Change From Baseline
The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.
Measured: Baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 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.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886587
- Sponsor's protocol ID
- EMOECZ0002
- Status last verified
- Apr 2017
- First submitted
- 22 Apr 2009
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Active-Controlled Clinical Trial To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT00886587
- Acronym / sponsor ID
- EMOECZ0002
- Conditions
- Atopic Dermatitis
- Keywords
- eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 23 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 was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.
Detailed description
This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J\&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 11054-010 | Experimental | Device: F# 11054-010F# 11054-010 Investigational Device |
| 10495-053 | Active comparator | Device: F# 10495-053F# 10495-053 Atopiclair |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Post-menarchal female subjects must have a negative urine pregnancy test
- Willing to provide written informed consent/assent
- Diagnosed as having mild to moderate Atopic Dermatitis (AD)
- Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
- Willing to replace their body wash and/or soaps with the one provided in this trial
Key exclusion criteria (5 listed)
- Severe AD as determined by the Rajka-Langeland Severity Index
- AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
- History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
- Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
- Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
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 |
|---|---|---|
| F# 11054-010Also: Investigational DeviceApply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin. | Device | 11054-010 |
| F# 10495-053Also: Atopiclair® Skin and Wound EmulsionApply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin. | Device | 10495-053 |
Primary outcome
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
Time frame: Baseline to Day 43
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
3 secondary outcomes
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
Time frame: Baseline to Day 15
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
Time frame: Baseline to Day 43
Itch Score on Day 43 - Change From Baseline
Time frame: Baseline to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Qing Li, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F# 11054-010 and F# 10495-053 in people with Atopic Dermatitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites 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 5 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 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?
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline (time frame: Baseline to Day 43). 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 23 May 2017.