Mild to Moderate Atopic DermatitisNCT01079897
Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
A study testing Atopiclair and EHK02-01 in people with Mild to Moderate Atopic Dermatitis, run by Bitop AG at 4 sites in Germany.
Trial summary
This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days. Response to therapy is recorded at each visit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- Atopiclair and EHK02-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesGermany
- Study dates
- Mar 2010to Jun 2010
- 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
- Female or male individuals between 18 and 65 years in good general health diagnosed atopic dermatitis for ≥ 6 months, in active stage (active stage means severity as measured by overall IGA-Score between 1 and 4)
- At least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified, objective local SCORAD of the test areas > 5
- Both lesional areas of interest must have a difference in the modified, objective local SCORAD of ≤ 3
- Willingness to adhere to the schedule of the investigation, concomitant therapy prohibitions, restrictions, treatment regimen and procedures described in the CIP
- Written informed consent to participate in the trial, prior to any investigation related procedures, indicating an understanding of the purpose of the clinical investigation
- A patient of childbearing potential agrees to use a contraceptive methods for the duration of the investigation according to CPMP/ICH 286/95 note 3
Who cannot join
- Patients who are self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
- Patients with any skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results (e.g. psoriasis)
- Patients with a known malignancy
- Presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory dis-eases, immunosuppressive diseases, autoimmune diseases, liver or kidney diseases, severe infectious diseases)
- Patients who did not respect the wash-out periods prior to and during the clinical investigation
- Vaccination within 6 days prior to enrolment and during the study.
Show all 11Show fewer
- Patients with a known allergy against any ingredient of the test products
- Patients who are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
- Patients who participate in another clinical trial or have participated in another clinical trial within the last 30 days prior to the first day of investigation
- Patients who are involved in the organization of the clinical investigation
- Patients that are in any way dependant on the investigator
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Hautarztzentrum Tegel
Berlin, 13507
Hautarztpraxis
Freiburg im Breisgau, 79100
Gemeinschaftspraxis Mahlow
Mahlow, 15831
Haut- und Lasercentrum Potsdam
Potsdam, 14469
About this study
Official title: A Randomized, Comparator-controlled, Double-blind, Multicenter Intra-individual Clinical Trial to Evaluate the Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days. Response to therapy is recorded at each visit.
- Conditions
- Mild to Moderate Atopic Dermatitis
- Being tested
- Atopiclair, EHK02-01
- Keywords
- Atopic dermatitis, Ectoine, Treatment, Atopiclair, Medical device
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtopiclairDevice
Also called Zarzenda, MAS063DP, Atopiclair non-steroidal cream
topical applied cream, twice daily
EHK02-01Device
Also called ectoine-containing cream,, 7% Ectoin
topical applied cream containing 7% ectoine
| Study group | Role | What they receive |
|---|---|---|
| Atopiclair | Active comparator | Not described Receives: Device: Atopiclair |
| EHK02-01 | Experimental | Ectoine containing cream Receives: Device: EHK02-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of a modified, objective (local) SCORAD
Measured: 28 days
Secondary outcomes (7)
Change of local IGA
Measured: 28 days
Change of Pruritus
Measured: 28 days
Patient's judgment on efficacy
Measured: 28 days
AEs during treatment phase
Measured: 28 days
Physical examination
Measured: 28 days
Patient's assessment of tolerability and safe
Measured: 28 days
change of the modified, objective local SCORAD
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Vanscheidt, Professor, Principal investigator, Professor Dr. med Wolfgang Vanscheid (Hautarzt, Allergologie, Phlebologie)Tanja Fischer, Dr., Principal investigator, Haut- und Lasercentrum PotsdamMartin Miehe, Dr., Principal investigator, Hautarztzentrum TegelMichael Sebastian, Dr., Principal investigator, Facharzt für Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079897
- Sponsor's protocol ID
- 133-002
- Other IDs
- 0010287
- Status last verified
- Oct 2011
- First submitted
- 2 Mar 2010
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparator-controlled, Double-blind, Multicenter Intra-individual Clinical Trial to Evaluate the Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01079897
- Acronym / sponsor ID
- 133-002
- Conditions
- Mild to Moderate Atopic Dermatitis
- Keywords
- Atopic dermatitis, Ectoine, Treatment, Atopiclair, Medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Mar 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 evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days. Response to therapy is recorded at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopiclair | Active comparator | Device: Atopiclair |
| EHK02-01 | Experimental | Device: EHK02-01Ectoine containing cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male individuals between 18 and 65 years in good general health diagnosed atopic dermatitis for ≥ 6 months, in active stage (active stage means severity as measured by overall IGA-Score between 1 and 4)
- At least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified, objective local SCORAD of the test areas > 5
- Both lesional areas of interest must have a difference in the modified, objective local SCORAD of ≤ 3
- Willingness to adhere to the schedule of the investigation, concomitant therapy prohibitions, restrictions, treatment regimen and procedures described in the CIP
- Written informed consent to participate in the trial, prior to any investigation related procedures, indicating an understanding of the purpose of the clinical investigation
Key exclusion criteria (11 listed)
- Patients who are self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
- Patients with any skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results (e.g. psoriasis)
- Patients with a known malignancy
- Presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory dis-eases, immunosuppressive diseases, autoimmune diseases, liver or kidney diseases, severe infectious diseases)
- Patients who did not respect the wash-out periods prior to and during the clinical investigation
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 |
|---|---|---|
| AtopiclairAlso: Zarzenda, MAS063DP, Atopiclair non-steroidal creamtopical applied cream, twice daily | Device | Atopiclair |
| EHK02-01Also: ectoine-containing cream,, 7% Ectointopical applied cream containing 7% ectoine | Device | EHK02-01 |
Primary outcome
change of a modified, objective (local) SCORAD
Time frame: 28 days
7 secondary outcomes
Change of local IGA
Time frame: 28 days
Change of Pruritus
Time frame: 28 days
Patient's judgment on efficacy
Time frame: 28 days
AEs during treatment phase
Time frame: 28 days
Physical examination
Time frame: 28 days
Patient's assessment of tolerability and safe
Time frame: 28 days
change of the modified, objective local SCORAD
Time frame: 7 days
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 18 Oct 2011.
Related trials for Mild to Moderate Atopic Dermatitis
RecruitingPhase 2
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis
Dermatitis Atopic
Not yet recruitingPhase 2
To Evaluate the Safety and Efficacy of Hemay5394 in Patients With Mild to Moderate Atopic Dermatitis
Safety, Efficiency
Not yet recruitingPhase 2
A Study of JYP0066 Cream in Mild-to-Moderate Atopic Dermatitis
Atopic Dermatitis (AD)
Recruiting
Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and Adults
Atopic Dermatitis, Emollients
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
Mild to Moderate Atopic Dermatitis
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.
Wolfgang Vanscheidt, Professor principal investigator
Professor Dr. med Wolfgang Vanscheid (Hautarzt, Allergologie, Phlebologie)
Tanja Fischer, Dr. principal investigator
Haut- und Lasercentrum Potsdam
Martin Miehe, Dr. principal investigator
Hautarztzentrum Tegel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atopiclair and EHK02-01 in people with Mild to Moderate Atopic Dermatitis, run by Bitop AG at 4 sites 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 6 inclusion and 11 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 18 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
change of a modified, objective (local) SCORAD (time frame: 28 days). 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 18 Oct 2011.