Seborrheic DermatitisPhase 2NCT00403559
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
A Phase 2 study testing Elidel and Ketoconazole Cream in people with Seborrheic Dermatitis, run by Dermatology Specialists Research at 1 site in United States.
Trial summary
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Elidel and Ketoconazole Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2007to 27 Feb 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 or older and sign written informed consent.
- Must be wiling and able to comply with protocol.
- Must have active seborrheic dermatitis of the face.
Who cannot join
- No history of overt bacterial, viral or fungal infection of the head/neck.
- No history or presence of compromising dermatosis elsewhere on the skin
- No Parkinson's disease, HIV, infections or disorders of the central nervous system
- No actinically damaged skin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
Read the detailed description
This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Elidel, Ketoconazole Cream
- Keywords
- seborrheic dermatitis
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElidelDrug
Also called pimecrolimus
Ketoconazole CreamDrug
Also called Nizoral
| Study group | Role | What they receive |
|---|---|---|
| Elidel Cream (pimecrolimus) | Experimental | Elidel Cream to be applied twice daily for 4 weeks Receives: Drug: Elidel |
| Ketoconazole Cream (Nizoral) | Active comparator | Ketoconazole Cream to be applied twice daily for 4 weeks Receives: Drug: Ketoconazole Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas).
Measured: One week from Baseline
Secondary outcomes (1)
Key Secondary Efficacy Will be the % of Patients With Facial Clearance
Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study start7 May 2007
- Primary completion20 Feb 2009
- Study completion27 Feb 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 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
- Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatology Specialists Research
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Steven Kempers, MD, Principal investigator, Associated Skin Care SpecialistsBernard Goffe, MD, Principal investigator, Dermatology AssociatesDebra Breneman, MD, Principal investigator, University of Cincinnati - Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403559
- Sponsor's protocol ID
- CASM981CUS37
- Other IDs
- SAIRB # 06-4893, IND 75,225
- Status last verified
- Mar 2022
- First submitted
- 21 Nov 2006
- Last updated
- 14 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT00403559
- Acronym / sponsor ID
- CASM981CUS37
- Conditions
- Seborrheic Dermatitis
- Keywords
- seborrheic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Dermatology Specialists ResearchUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 7 May 2007 (actual)
- Primary completion
- 20 Feb 2009 (actual)
- Study completion
- 27 Feb 2009 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Posted 14 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
Detailed description
This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elidel Cream (pimecrolimus) | Experimental | Drug: ElidelElidel Cream to be applied twice daily for 4 weeks |
| Ketoconazole Cream (Nizoral) | Active comparator | Drug: Ketoconazole CreamKetoconazole Cream to be applied twice daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be 18 or older and sign written informed consent.
- Must be wiling and able to comply with protocol.
- Must have active seborrheic dermatitis of the face.
Key exclusion criteria (4 listed)
- No history of overt bacterial, viral or fungal infection of the head/neck.
- No history or presence of compromising dermatosis elsewhere on the skin
- No Parkinson's disease, HIV, infections or disorders of the central nervous system
- No actinically damaged skin
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 |
|---|---|---|
| ElidelAlso: pimecrolimus | Drug | Elidel Cream (pimecrolimus) |
| Ketoconazole CreamAlso: Nizoral | Drug | Ketoconazole Cream (Nizoral) |
Primary outcome
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
Time frame: One week from Baseline
F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas).
1 secondary outcome
Key Secondary Efficacy Will be the % of Patients With Facial Clearance
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- 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.
Steven Kempers, MD principal investigator
Associated Skin Care Specialists
Bernard Goffe, MD principal investigator
Dermatology Associates
Debra Breneman, MD principal investigator
University of Cincinnati - Dermatology
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 Elidel and Ketoconazole Cream in people with Seborrheic Dermatitis, run by Dermatology Specialists Research 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 4 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 14 Mar 2022. 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 14 Mar 2022). 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?
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. (time frame: One week from Baseline). 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 14 Mar 2022.