Atopic DermatitisNCT01132079
Pimecrolimus and Epidermal Barrier Function
A study testing cream treatment in people with Atopic Dermatitis, run by University of Kiel at 1 site in Germany.
Trial summary
This study seeks to investigate the role of pimecrolimus in restoring disturbed skin barrier function and reversing epidermal abnormalities found in atopic dermatitis (AD). The project is based on findings the investigators presented at the recent SID meeting in Providence and published in the J Invest Dermatol (122… 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?
- cream treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to not given
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects may be included only if the following apply at the baseline visit (day 0, before first application of study medication).
- Patients to be included are:
- Males and females of any race.
- >= 18 years old.
- Have atopic dermatitis as defined by Hanifin and Rajka criteria.
- History of mild to moderate atopic dermatitis
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- At least 10 % of each upper limb affected by atopic dermatitis excluding the surface area of the hands, as these will not be treated in order to avoid cross-contamination. As reference: one hand (palm and fingers) corresponds to 10% of patient's upper limb surface.
- One specific, representative area of the disease on each upper limb with similar size and severity on both upper limbs. These will be considered the target lesions.
- A target lesion score of at least 3 to 8 (on a scale of 0-12) for both right and left target lesions and not differing more than 1 score point between the right and left sides.
- be able to suspended treatment of atopic dermatitis with other therapies for the duration of the study (4-6 weeks).
- Must be informed of study procedures and have signed the informed consent form approved for the study.
Who cannot join
- Females:
- Who are pregnant or breastfeeding.
- Who are menstruating, capable of becoming pregnant and not practicing a medically approved method of contraception. "Medically approved" contraceptive may, at the discretion of the investigator, include abstinence. (If patients are on oral contraceptives, they must have begun treatment at least one month prior to baseline and continue at least four weeks after the last treatment).
- Other therapies/medications:
- Prior phototherapy or systemic therapy known to or suspected to have an effect on atopic dermatitis within 14 days prior to first application of study medication. Patients on a low stable dose of inhaled steroids (dose known to have negligible systemic absorption) and systemic antihistamines may participate.
- Topical therapy known to or suspected to have an effect on atopic dermatitis (including topical steroids, topical tacrolimus ointment or topical pimecrolimus cream) on the upper limbs within 7 days prior to first application of study medication.
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- Topical therapy known to or suspected to have an effect on atopic dermatitis on other areas than upper limbs if total body surface treated is higher than 20% (due to the higher risk of systemic absorption affecting the lesions of the upper limbs) within 7 days prior to first application of study medication
- Concurrent diseases / conditions and history of their diseases / conditions:
- Patients who have signs of skin atrophy and corticoid damage on the target areas
- Patients who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome)
- Patients who have concurrent skin disease (e.g. impetigo) on or near the study area which could interfere with study evaluations
- Patients who have acute viral skin infections (e.g. herpes simplex, varicella zoster) Investigational drug / therapy use.
- Patients who have used investigational drugs within 8 weeks prior to first application of study medication or intend to use other investigational drugs during the course of the study Ingredient hypersensitivity
- Patients with known hypersensitivity to any ingredient of the study medication (see technical information sheet) Compliance / reliability / investigator judgment
- Patients who who are, in the opinion of the investigator, known to be unreliable or non-compliant with medical treatment, or are known to miss appointments (according to patient records)
- Patients who drug abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully
- Patients who any other condition or prior/present treatment which, in the opinion of the investigator, will render the patient ineligible for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role for Pimecrolimus in Restoring Skin Barrier Function and Normalizing Epidermal Lipid Content and Differentiation in Atopic Epidermis: a Randomized, Intra-patient, Double-blind (Right/Left Arm) Study in Adults With Atopic Dermatitis Treated With 1 % Pimecrolimus Cream and 0.1 % Betamethasone Cream as Treatment Control Twice Daily for 3 Weeks
This study seeks to investigate the role of pimecrolimus in restoring disturbed skin barrier function and reversing epidermal abnormalities found in atopic dermatitis (AD). The project is based on findings the investigators presented at the recent SID meeting in Providence and published in the J Invest Dermatol (122: 1423-31, 2004). The investigators research shows that AD is characterized by impaired skin barrier function, reduced stratum corneum hydration, impaired epidermal lipid composition and epidermal differentiation. In this proposed project, the investigators wish to examine the influence of pimecrolimus and betamethasone valerate on transepidermal water loss (TEWL) as a marker of the skin barrier function, on stratum corneum hydration, on stratum corneum lipid content and on epidermal differentiation regarding keratins and cornified envelope proteins in AD patients. The study involves biophysical measurements of TEWL and skin hydration, lipid analysis, immuno-histochemistry, Western blotting and micro array techniques. This study shall clarify whether pimecrolimus restores the epidermal barrier and whether this contributes to the beneficial effect of pimecrolimus on AD.
Objectives:
To explore the stratum corneum hydration, transepidermal water loss, capacity for barrier repair and the integrity of the stratum corneum in patients treated with 1 % pimecrolimus cream when applied twice a day to atopic dermatitis of the upper limbs, and to access the substance's influences on the epidermis through histological, ultra-structural, and biochemical analysis using punch biopsies from day 1 of one arm and day 22 from both treated arms. 0.1 % betamethasone valerate cream b.i.d will be used as a control treatment.
- Conditions
- Atopic Dermatitis
- Being tested
- cream treatment
- Keywords
- atopic dermatitis, barrier function, pimecrolimus
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cream treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus cream treatment | Experimental | Not described Receives: Drug: cream treatment |
| Betamethasone valerate cream treatment | Active comparator | Not described Receives: Drug: cream treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the effect of 1 % pimecrolimus cream on the epidermis in adults with AD
To explore the effect of 1 % pimecrolimus cream on the epidermis in adults with AD (with 0.1 % betamethasone serving as control) by testing the hypothesis that:
- 1 % pimecrolimus cream leads to a reduction of biophysical parameters of AD representing the permeability barrier of the skin after three weeks of treatment.
- To explore the epidermal effect on proliferation rate, differentiation, and stratum corneum lipid content.
Secondary outcomes (1)
To explore the effect of 1 % pimecrolimus cream induced changes in ultra-structure and gene expression in the epidermis
- To explore the effect of 1 % pimecrolimus cream induced changes in ultra-structure and gene expression in the epidermis.
- To compare the key protein molecules of keratinocyte growth and differentiation and their gene expression in relationship to clinical skin improvement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Forschungsgemeinschaft, Bonn, Germany, Novartis Pharma GmbH, Nürnberg, Germany
- Investigators
- Ehrhardt Proksch, MD, PhD, Principal investigator, Dept. of Dermatology, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132079
- Sponsor's protocol ID
- Protocol No. ELBE-2005
- Status last verified
- Mar 2005
- First submitted
- 26 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
Publications
Jensen JM, Pfeiffer S, Witt M, Brautigam M, Neumann C, Weichenthal M, Schwarz T, Folster-Holst R, Proksch E. Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. J Allergy Clin Immunol. 2009 May;123(5):1124-33. doi: 10.1016/j.jaci.2009.03.032.
PubMed 19410693Jensen JM, Pfeiffer S, Witt M, Brautigam M, Neumann C, Weichenthal M, Schwarz T, Folster-Holst R, Proksch E. Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. J Allergy Clin Immunol. 2009 Sep;124(3 Suppl 2):R19-28. doi: 10.1016/j.jaci.2009.07.015.
PubMed 19720208
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role for Pimecrolimus in Restoring Skin Barrier Function and Normalizing Epidermal Lipid Content and Differentiation in Atopic Epidermis: a Randomized, Intra-patient, Double-blind (Right/Left Arm) Study in Adults With Atopic Dermatitis Treated With 1 % Pimecrolimus Cream and 0.1 % Betamethasone Cream as Treatment Control Twice Daily for 3 Weeks
- ClinicalTrials.gov ID
- NCT01132079
- Acronym / sponsor ID
- Protocol No. ELBE-2005
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, barrier function, pimecrolimus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- Deutsche Forschungsgemeinschaft, Bonn, Germany, Novartis Pharma GmbH, Nürnberg, Germany
- Study start
- Mar 2005
- First posted
- 27 May 2010 (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.
This study seeks to investigate the role of pimecrolimus in restoring disturbed skin barrier function and reversing epidermal abnormalities found in atopic dermatitis (AD). The project is based on findings the investigators presented at the recent SID meeting in Providence and published in the J Invest Dermatol (122: 1423-31, 2004). The investigators research shows that AD is characterized by impaired skin barrier function, reduced stratum corneum hydration, impaired epidermal lipid composition and epidermal differentiation. In this proposed project, the investigators wish to examine the influence of pimecrolimus and betamethasone valerate on transepidermal water loss (TEWL) as a marker of the skin barrier function, on stratum corneum hydration, on stratum corneum lipid content and on epidermal differentiation regarding keratins and cornified envelope proteins in AD patients. The study involves biophysical measurements of TEWL and skin hydration, lipid analysis, immuno-histochemistry, Western blotting and micro array techniques. This study shall clarify whether pimecrolimus restores the epidermal barrier and whether this contributes to the beneficial effect of pimecrolimus on AD.
Objectives:
To explore the stratum corneum hydration, transepidermal water loss, capacity for barrier repair and the integrity of the stratum corneum in patients treated with 1 % pimecrolimus cream when applied twice a day to atopic dermatitis of the upper limbs, and to access the substance's influences on the epidermis through histological, ultra-structural, and biochemical analysis using punch biopsies from day 1 of one arm and day 22 from both treated arms. 0.1 % betamethasone valerate cream b.i.d will be used as a control treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus cream treatment | Experimental | Drug: cream treatment |
| Betamethasone valerate cream treatment | Active comparator | Drug: cream treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects may be included only if the following apply at the baseline visit (day 0, before first application of study medication).
- Males and females of any race.
- >= 18 years old.
- Have atopic dermatitis as defined by Hanifin and Rajka criteria.
- History of mild to moderate atopic dermatitis
Key exclusion criteria (17 listed)
- Who are pregnant or breastfeeding.
- Who are menstruating, capable of becoming pregnant and not practicing a medically approved method of contraception. "Medically approved" contraceptive may, at the discretion of the investigator, include abstinence. (If patients are on oral contraceptives, they must have begun treatment at least one month prior to baseline and continue at least four weeks after the last treatment).
- Prior phototherapy or systemic therapy known to or suspected to have an effect on atopic dermatitis within 14 days prior to first application of study medication. Patients on a low stable dose of inhaled steroids (dose known to have negligible systemic absorption) and systemic antihistamines may participate.
- Topical therapy known to or suspected to have an effect on atopic dermatitis (including topical steroids, topical tacrolimus ointment or topical pimecrolimus cream) on the upper limbs within 7 days prior to first application of study medication.
- Topical therapy known to or suspected to have an effect on atopic dermatitis on other areas than upper limbs if total body surface treated is higher than 20% (due to the higher risk of systemic absorption affecting the lesions of the upper limbs) within 7 days prior to first application of study medication
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 |
|---|---|---|
| cream treatment | Drug | Betamethasone valerate cream treatment, Pimecrolimus cream treatment |
Primary outcome
To explore the effect of 1 % pimecrolimus cream on the epidermis in adults with AD
To explore the effect of 1 % pimecrolimus cream on the epidermis in adults with AD (with 0.1 % betamethasone serving as control) by testing the hypothesis that: 1. 1 % pimecrolimus cream leads to a reduction of biophysical parameters of AD representing the permeability barrier of the skin after three weeks of treatment. 2. To explore the epidermal effect on proliferation rate, differentiation, and stratum corneum lipid content.
1 secondary outcome
To explore the effect of 1 % pimecrolimus cream induced changes in ultra-structure and gene expression in the epidermis
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 27 May 2010.
- Results publication: PubMed 19410693Jensen JM, Pfeiffer S, Witt M, Brautigam M, Neumann C, Weichenthal M, Schwarz T, Folster-Holst R, Proksch E. Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. J Allergy Clin Immunol. 2009 May;123(5):1124-33. doi: 10.1016/j.jaci.2009.03.032.
- Results publication: PubMed 19720208Jensen JM, Pfeiffer S, Witt M, Brautigam M, Neumann C, Weichenthal M, Schwarz T, Folster-Holst R, Proksch E. Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. J Allergy Clin Immunol. 2009 Sep;124(3 Suppl 2):R19-28. doi: 10.1016/j.jaci.2009.07.015.
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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.
Ehrhardt Proksch, MD, PhD principal investigator
Dept. of Dermatology, University of Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cream treatment in people with Atopic Dermatitis, run by University of Kiel 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 11 inclusion and 17 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 27 May 2010. 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.
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?
To explore the effect of 1 % pimecrolimus cream on the epidermis in adults with AD. 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 NCT01132079, which also lists 2 linked publications.
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 27 May 2010; AzTrials last refreshed its copy on 28 Oct 2026.