Atopic DermatitisPhase 4NCT00367393
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
A Phase 4 study testing Pimecrolimus cream 1% in people with Atopic Dermatitis, run by Novartis at 1 site in Germany.
Trial summary
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus cream 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Dec 2007
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinically diagnosed AD
- almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)
- clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
- Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas
Who cannot join
- Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
- Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
- Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus cream 1%
- Keywords
- Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, 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.
Pimecrolimus cream 1%Drug
Also called ASM981
Pimecrolimus cream 1% bid, as needed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus cream 1% Receives: Drug: Pimecrolimus cream 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study
Measured: 48 weeks
Secondary outcomes (5)
• Epidermal thickness by optical coherence tomography at selected investigational centers
Measured: 48 weeks
Skin thickness by ultrasound at selected investigational centers
Measured: 48 weeks
Epidermal thickness by 3mm punch biopsies (optional)
Measured: 48 weeks
Skin metabolism by suction blisters.
Measured: 48 weeks
Investigator's Global Assessment (IGA)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
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 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharm, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367393
- Sponsor's protocol ID
- CASM981CDE20
- Status last verified
- Feb 2017
- First submitted
- 21 Aug 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
Publications
Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage
- ClinicalTrials.gov ID
- NCT00367393
- Acronym / sponsor ID
- CASM981CDE20
- Conditions
- Atopic Dermatitis
- Keywords
- Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Aug 2006 (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.
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pimecrolimus cream 1%Pimecrolimus cream 1% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- clinically diagnosed AD
- almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)
- clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
- Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas
Key exclusion criteria (3 listed)
- Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
- Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
- Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation
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 |
|---|---|---|
| Pimecrolimus cream 1%Also: ASM981Pimecrolimus cream 1% bid, as needed | Drug | 1 |
Primary outcome
• Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study
Time frame: 48 weeks
5 secondary outcomes
• Epidermal thickness by optical coherence tomography at selected investigational centers
Time frame: 48 weeks
Skin thickness by ultrasound at selected investigational centers
Time frame: 48 weeks
Epidermal thickness by 3mm punch biopsies (optional)
Time frame: 48 weeks
Skin metabolism by suction blisters.
Time frame: 48 weeks
Investigator's Global Assessment (IGA)
Time frame: 48 weeks
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 24 Feb 2017.
- BackgroundReference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org
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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.
Novartis Pharm study chair
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pimecrolimus cream 1% in people with Atopic 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 4 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 24 Feb 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
• Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study (time frame: 48 weeks). 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 NCT00367393, 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 24 Feb 2017.