Perioral DermatitisPhase 3NCT00232115
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
A Phase 3 study testing Pimecrolimus in people with Perioral Dermatitis, run by Novartis at 1 site in Germany.
Trial summary
An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis. This study is not enrolling patients in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioral Dermatitis
- What is being tested?
- Pimecrolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Jul 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
- minimum severity score (PODSI) ≥ 4
- age 18 and older
Who cannot join
- Ongoing use of the following treatments is NOT allowed after the start of study drug:
- Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).
- Systemic immunosuppression
- History of malignancy of any organ system, treated or untreated, within the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.
This study is not enrolling patients in the United States.
- Conditions
- Perioral Dermatitis
- Being tested
- Pimecrolimus, Placebo
- Keywords
- Perioral Dermatitis, pimecrolimus cream
- Medical subject headings
- Dermatitis, Perioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel
Pimecrolimus cream 1 %
PlaceboDrug
Vehicle cream (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus Receives: Drug: Pimecrolimus |
| 2 | Placebo comparator | Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the Perioral Dermatitis Severity Index
Secondary outcomes (4)
Time to disease recurrence
Response rates
Patient's quality of life assessment
Patient's disease severity assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioral 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharma AG, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232115
- Sponsor's protocol ID
- CASM981CDE15
- Status last verified
- Jan 2008
- First submitted
- 3 Oct 2005
- Last updated
- 17 Jan 2008
- Results posted
- No
Publications
Schwarz T, Kreiselmaier I, Bieber T, Thaci D, Simon JC, Meurer M, Werfel T, Zuberbier T, Luger TA, Wollenberg A, Brautigam M. A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis. J Am Acad Dermatol. 2008 Jul;59(1):34-40. doi: 10.1016/j.jaad.2008.03.043. Epub 2008 May 7.
PubMed 18462835
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
- ClinicalTrials.gov ID
- NCT00232115
- Acronym / sponsor ID
- CASM981CDE15
- Conditions
- Perioral Dermatitis
- Keywords
- Perioral Dermatitis, pimecrolimus cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 4 Oct 2005 (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.
An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.
This study is not enrolling patients in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PimecrolimusPimecrolimus |
| 2 | Placebo comparator | Drug: PlaceboVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
- minimum severity score (PODSI) ≥ 4
- age 18 and older
Key exclusion criteria (4 listed)
- Ongoing use of the following treatments is NOT allowed after the start of study drug:
- Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).
- Systemic immunosuppression
- History of malignancy of any organ system, treated or untreated, within the past 5 years
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 |
|---|---|---|
| PimecrolimusAlso: ElidelPimecrolimus cream 1 % | Drug | 1 |
| PlaceboVehicle cream (placebo) | Drug | 2 |
Primary outcome
Reduction of the Perioral Dermatitis Severity Index
4 secondary outcomes
Time to disease recurrence
Response rates
Patient's quality of life assessment
Patient's disease severity assessment
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 17 Jan 2008.
- Derived from this study: PubMed 18462835Schwarz T, Kreiselmaier I, Bieber T, Thaci D, Simon JC, Meurer M, Werfel T, Zuberbier T, Luger TA, Wollenberg A, Brautigam M. A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis. J Am Acad Dermatol. 2008 Jul;59(1):34-40. doi: 10.1016/j.jaad.2008.03.043. Epub 2008 May 7.
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.
Novartis Pharma AG study chair
Novartis Pharmaceuticals
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 Pimecrolimus in people with Perioral Dermatitis, run by Novartis at 1 site in Germany.
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 17 Jan 2008. 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 Germany. 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?
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?
Reduction of the Perioral Dermatitis Severity Index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00232115, which also lists 1 linked publication.
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 17 Jan 2008; AzTrials last refreshed its copy on 8 Nov 2026.