Seborrheic DermatitisPhase 2NCT01703793
Safety and Efficacy Study in Subjects With Seborrheic Dermatitis
A Phase 2 study testing Test Product 49778 and Test Product 10156 in people with Seborrheic Dermatitis, run by Medicis Global Service Corporation at 22 sites in United States.
Trial summary
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Test Product 49778 and Test Product 10156
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 22 sitesUnited States
- Study dates
- Sep 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Investigator assessment of seborrheic dermatitis.
- Additional criteria as identified in the protocol.
Who cannot join
- History of or ongoing psoriasis of the scalp.
- History of or ongoing atopic dermatitis of the scalp.
- Additional criteria as identified in the protocol.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Study site
Arlington, Texas
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Aventura, Florida
Study site
College Station, Texas
Study site
Detroit, Michigan
Study site
Evansville, Indiana
Study site
Fremont, California
Study site
Fridley, Minnesota
Study site
High Point, North Carolina
Study site
Los Angeles, California
Study site
Mount Kisco, New York
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Paramus, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
Plano, Texas
Study site
Portland, Oregon
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Snellville, Georgia
Study site
Webster, Texas
About this study
Official title: A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Test Product 49778, Test Product 10156, Vehicle (placebo)
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product 49778Drug
Test Product 10156Drug
Vehicle (placebo)Drug
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle (placebo) treatment, twice a week for four weeks. Receives: Drug: Vehicle (placebo) |
| Test Product 10156 | Experimental | Product 10156 treatment, twice a week for four weeks. Receives: Drug: Test Product 10156 |
| Test Product 49778 | Experimental | Product 49778 treatment, twice a week for four weeks. Receives: Drug: Test Product 49778 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Improvement (investigator assessment)
Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4
Measured: Week 4
Secondary outcomes (1)
Symptom Improvement (subject assessment)
Assess the change in the pruritus score from baseline to week 2 and to week 4.
Measured: Weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ira Lawrence, MD, Study chair, Medicis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703793
- Sponsor's protocol ID
- MP-1001-01
- Status last verified
- Jan 2013
- First submitted
- 7 Oct 2012
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT01703793
- Acronym / sponsor ID
- MP-1001-01
- Conditions
- Seborrheic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
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 determine if two test products are safe and effective in the treatment of seborrheic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: Vehicle (placebo)Vehicle (placebo) treatment, twice a week for four weeks. |
| Test Product 10156 | Experimental | Drug: Test Product 10156Product 10156 treatment, twice a week for four weeks. |
| Test Product 49778 | Experimental | Drug: Test Product 49778Product 49778 treatment, twice a week for four weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Investigator assessment of seborrheic dermatitis.
- Additional criteria as identified in the protocol.
Key exclusion criteria (3 listed)
- History of or ongoing psoriasis of the scalp.
- History of or ongoing atopic dermatitis of the scalp.
- Additional criteria as identified in the protocol.
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 |
|---|---|---|
| Test Product 49778 | Drug | Test Product 49778 |
| Test Product 10156 | Drug | Test Product 10156 |
| Vehicle (placebo) | Drug | Vehicle |
Primary outcome
Symptom Improvement (investigator assessment)
Time frame: Week 4
Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4
1 secondary outcome
Symptom Improvement (subject assessment)
Time frame: Weeks 2 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
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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.
Ira Lawrence, MD study chair
Medicis Pharmaceutical
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Test Product 49778 and Test Product 10156 in people with Seborrheic Dermatitis, run by Medicis Global Service Corporation at 22 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 2 inclusion and 3 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 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom Improvement (investigator assessment) (time frame: Week 4). 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 9 Jan 2013.