Atopic DermatitisPhase 3NCT01053247
Study of 0416 Ointment in the Treatment of Atopic Dermatitis
A Phase 3 study testing 0416 and tacrolimus ointment 0.1% in people with Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- 0416 and tacrolimus ointment 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 793 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Atopic Dermatitis
- Good health with the exception of Atopic Dermatitis
- Percent Body Surface Area minimum requirements
Who cannot join
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Fougera Pharmaceuticals Inc.
Melville, New York, 11747
About this study
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- 0416, Vehicle of 0416 test product, tacrolimus ointment 0.1%
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0416Drug
Topical 0416 test product applied twice daily for 2 weeks
Vehicle of 0416 test productDrug
Vehicle of 0416 test product applied twice daily for 2 weeks
tacrolimus ointment 0.1%Drug
Reference Product for 0416 test product. Apply twice daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Test product that contains the active pharmaceutical ingredient Receives: Drug: 0416 |
| Reference | Active comparator | Reference product that contains active pharmaceutical ingredient Receives: Drug: tacrolimus ointment 0.1% |
| Vehicle | Placebo comparator | Placebo that contains no active pharmaceutical ingredient Receives: Drug: Vehicle of 0416 test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
Measured: 2 weeks
Secondary outcomes (1)
The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionAug 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fougera Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela C Kaplan, Study director, Fougera Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053247
- Sponsor's protocol ID
- 0416
- Status last verified
- Sep 2014
- First submitted
- 9 Dec 2009
- Last updated
- 3 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.
- ClinicalTrials.gov ID
- NCT01053247
- Acronym / sponsor ID
- 0416
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 3 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: 0416Test product that contains the active pharmaceutical ingredient |
| Reference | Active comparator | Drug: tacrolimus ointment 0.1%Reference product that contains active pharmaceutical ingredient |
| Vehicle | Placebo comparator | Drug: Vehicle of 0416 test productPlacebo that contains no active pharmaceutical ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Atopic Dermatitis
- Good health with the exception of Atopic Dermatitis
- Percent Body Surface Area minimum requirements
Key exclusion criteria (2 listed)
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis
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 |
|---|---|---|
| 0416Topical 0416 test product applied twice daily for 2 weeks | Drug | Test |
| Vehicle of 0416 test productVehicle of 0416 test product applied twice daily for 2 weeks | Drug | Vehicle |
| tacrolimus ointment 0.1%Reference Product for 0416 test product. Apply twice daily for 2 weeks. | Drug | Reference |
Primary outcome
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
Time frame: 2 weeks
1 secondary outcome
The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Angela C Kaplan study director
Fougera Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0416 and tacrolimus ointment 0.1% in people with Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. 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 3 inclusion and 2 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 3 Oct 2014. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Oct 2014). 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?
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment (time frame: 2 weeks). 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 3 Oct 2014.