Atopic DermatitisNCT03315611
Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis
A study testing Allergen challenge chamber in people with Atopic Dermatitis and Allergy Pollen, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and 'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis (AD) after two 4 h challenges with grass pollen on two consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Allergy Pollen
- What is being tested?
- Allergen challenge chamber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2017to 25 Apr 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal Intra Uterine Devices (IUD) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- For patient groups 1 and 2: Positive Immunglobulin E (IgE) level for Dactylis glomerata of at least ImmunoCAP fluoroenzyme immunoassay (CAP FEIA) class 3 at screening or within the last 12 months.
- atopic dermatitis fulfilling the United Kingdom (UK) criteria of AD
- SCORAD index between 20 and 50 points.
- Forced expiratory Volume in 1 second (FEV1) ≥ 80% pred. at screening.
- Smokers or non-smokers
- Applicable only for patients of the control group: No IgE-sensitization to grass pollen (including Dactylis glomerata)
Who cannot join
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
- Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA (Global Initiative for Asthma) guidelines
- Clinically relevant abnormalities in hematology or blood chemistry at screening.
- Positive Human Immunodeficiency Virus Antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
- Topical steroid treatment of air exposed skin (wash out phase: 2 weeks)
Show all 17Show fewer
- Topical calcineurin inhibitor treatment of air exposed skin (wash out phase: 2 weeks)
- Ultraviolet (UV) radiation treatment (wash out phase: 4 weeks)
- Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolate Mofetil (MMF); wash out phase: 4 weeks)
- Treatment with antihistamines (wash out phase: 1 week)
- Specific immunotherapy (SIT) with grass pollen allergens within the last 5 years
- Diastolic blood pressure above 95 mmHg.
- Febrile illness within 2 weeks prior to screening.
- Alcohol or drug abuse within 12 month prior to screening.
- Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form.
- Participation in another clinical trial 30 days prior to enrolment.
- Risk of non-compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis After Challenges With Grass Pollen in the Fraunhofer Allergen Challenge Chamber
The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and 'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to understand the specificity of the grass pollen exposure.
Read the detailed description
After the screening assessments the subject's whole skin will be treated for a period of 12 days with either 'Eucerin AtopiControl LOTION' or 'Eucerin AtopiControl facial cream' or will receive no treatment until Day 1 of the study. All patients will be challenged for 4 hours on two consecutive days (Day1 and 2) with 4000 pollen grains/m³ of Dactylis glomerata pollen. In this study approximately 9 subjects will be placed in the Environmental Exposure Chamber (ECC) at a time. At screening a blood sample will be taken for determination mutations of genes encoding for skin barrier proteins (e.g. filaggrin mutation). At day 1 and day 5 blood samples (serum) will be taken for biomarker assessments and lymphocyte proliferation assays (peripheral blood). The severity of atopic dermatitis will be rated (blinded observer, trained dermatologist) applying the 'SCORing Atopic Dermatitis (SCORAD) index, the objective SCORAD, local SCORAD and Investigator Global assessment (IGA). Assessment of itch and sleeplessness referring to the past 24 hous will be done by a blinded observer on each day including baseline assessments.
- Conditions
- Atopic Dermatitis, Allergy Pollen
- Being tested
- 'Eucerin AtopiControl Lotion' (for the body), Allergen challenge chamber
- Medical subject headings
- Dermatitis, Atopic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Eucerin AtopiControl Lotion' (for the body)Drug
Also called 'Eucerin AtopiControl facial cream' (for the face), Two 4h-challenges with grass pollen on two consecutive days
Treatment with Eucerin AtopiControl Lotion
Allergen challenge chamberOther
Exposure to Dactylis glomerata pollen in an environmental challenge chamber
| Study group | Role | What they receive |
|---|---|---|
| AD, sensitized, treated | Active comparator | Allergen challenge chamber and Treatment for 12 day with 'Eucerin AtopiControl Lotion' (for the body) and 'Eucerin AtopiControl facial cream' (for the face): 1,2 g twice daily. Receives: Drug: 'Eucerin AtopiControl Lotion' (for the body); Other: Allergen challenge chamber |
| AD, not sensitized, not treated | Experimental | Allergen challenge chamber Receives: Other: Allergen challenge chamber |
| AD, sensitized, not treated | Experimental | Allergen challenge chamber Receives: Other: Allergen challenge chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD Day 3
Difference of change in objective SCORAD in treated versus untreated patients
Measured: Day 3: pre- 4 hour-challenge with grass pollen and post-4 hour-challenge with grass pollen
Secondary outcomes (1)
SCORAD Day 1,2,4,5
Difference of change in objective SCORAD in treated versus untreated patients
Measured: Day 1,2,4,5: pre- 4 hour -challenge with grass pollen and post-4 hour-challenge with grass pollen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start2 Oct 2017
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The working hypothesis fo this study is, that local treatment with 'Eucerin AtopiControl Lotion' and 'Eucerin AtopiControl Gesichtscreme' compared to no treatment signifixantly reduces the increase of SCORAD that is elicited during challenge in an environmental challenge chamber (ECC) with grass pollen.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, MD, Principal investigator, The Fraunhofer-Gesellschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315611
- Sponsor's protocol ID
- 16-09 Neurop 2
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis After Challenges With Grass Pollen in the Fraunhofer Allergen Challenge Chamber
- ClinicalTrials.gov ID
- NCT03315611
- Acronym / sponsor ID
- 16-09 Neurop 2
- Conditions
- Atopic Dermatitis, Allergy Pollen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- 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 objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and 'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to understand the specificity of the grass pollen exposure.
Detailed description
After the screening assessments the subject's whole skin will be treated for a period of 12 days with either 'Eucerin AtopiControl LOTION' or 'Eucerin AtopiControl facial cream' or will receive no treatment until Day 1 of the study. All patients will be challenged for 4 hours on two consecutive days (Day1 and 2) with 4000 pollen grains/m³ of Dactylis glomerata pollen. In this study approximately 9 subjects will be placed in the Environmental Exposure Chamber (ECC) at a time. At screening a blood sample will be taken for determination mutations of genes encoding for skin barrier proteins (e.g. filaggrin mutation). At day 1 and day 5 blood samples (serum) will be taken for biomarker assessments and lymphocyte proliferation assays (peripheral blood). The severity of atopic dermatitis will be rated (blinded observer, trained dermatologist) applying the 'SCORing Atopic Dermatitis (SCORAD) index, the objective SCORAD, local SCORAD and Investigator Global assessment (IGA). Assessment of itch and sleeplessness referring to the past 24 hous will be done by a blinded observer on each day including baseline assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The working hypothesis fo this study is, that local treatment with 'Eucerin AtopiControl Lotion' and 'Eucerin AtopiControl Gesichtscreme' compared to no treatment signifixantly reduces the increase of SCORAD that is elicited during challenge in an environmental challenge chamber (ECC) with grass pollen.
| Arm | Type | Receives |
|---|---|---|
| AD, sensitized, treated | Active comparator | Drug: 'Eucerin AtopiControl Lotion' (for the body), Other: Allergen challenge chamberAllergen challenge chamber and Treatment for 12 day with 'Eucerin AtopiControl Lotion' (for the body) and 'Eucerin AtopiControl facial cream' (for the face): 1,2 g twice daily. |
| AD, not sensitized, not treated | Experimental | Other: Allergen challenge chamberAllergen challenge chamber |
| AD, sensitized, not treated | Experimental | Other: Allergen challenge chamberAllergen challenge chamber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal Intra Uterine Devices (IUD) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- For patient groups 1 and 2: Positive Immunglobulin E (IgE) level for Dactylis glomerata of at least ImmunoCAP fluoroenzyme immunoassay (CAP FEIA) class 3 at screening or within the last 12 months.
- atopic dermatitis fulfilling the United Kingdom (UK) criteria of AD
- SCORAD index between 20 and 50 points.
Key exclusion criteria (17 listed)
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
- Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA (Global Initiative for Asthma) guidelines
- Clinically relevant abnormalities in hematology or blood chemistry at screening.
- Positive Human Immunodeficiency Virus Antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
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 |
|---|---|---|
| 'Eucerin AtopiControl Lotion' (for the body)Also: 'Eucerin AtopiControl facial cream' (for the face), Two 4h-challenges with grass pollen on two consecutive daysTreatment with Eucerin AtopiControl Lotion | Drug | AD, sensitized, treated |
| Allergen challenge chamberExposure to Dactylis glomerata pollen in an environmental challenge chamber | Other | AD, not sensitized, not treated, AD, sensitized, not treated, AD, sensitized, treated |
Primary outcome
SCORAD Day 3
Time frame: Day 3: pre- 4 hour-challenge with grass pollen and post-4 hour-challenge with grass pollen
Difference of change in objective SCORAD in treated versus untreated patients
1 secondary outcome
SCORAD Day 1,2,4,5
Time frame: Day 1,2,4,5: pre- 4 hour -challenge with grass pollen and post-4 hour-challenge with grass pollen
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 14 May 2018.
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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.
Jens Hohlfeld, MD principal investigator
The Fraunhofer-Gesellschaft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen challenge chamber in people with Atopic Dermatitis and Allergy Pollen, run by Fraunhofer-Institute of Toxicology and Experimental Medicine 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 8 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 14 May 2018. 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?
SCORAD Day 3 (time frame: Day 3: pre- 4 hour-challenge with grass pollen and post-4 hour-challenge with grass pollen). 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 May 2018.