Atopic DermatitisPhase 1/2NCT02094235
A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
A Phase 1/2 study testing E6005 0.05% and E6005 0.2% in people with Atopic Dermatitis, run by Organon and Co at 3 sites in Japan.
Trial summary
This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by… Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- E6005 0.05% and E6005 0.2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 3 sitesJapan
- Study dates
- Jan 2014to Jan 2015
- Phase
- Phase 1/2
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric out-patients diagnosed with AD aged 2 to 15 years at the time of written informed consent. Diagnosis for AD should be made in accordance with the "Guidelines for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
- Mild to moderate clinical symptoms appearing at baseline in areas where the application of study drug is possible, except the skin of face/head and non-dermal areas such as mucosa
- Evaluable skin lesions appearing at baseline. "Evaluable skin lesion" means rash area of 25 to 100 cm2 in the trunk or extremities, in which at least one of dermal symptoms (erythema, exudate/eschar, excoriation or lichenification) must be moderate in severity.
- Continuous use of an appropriate moisturizer for at least 14 days before baseline
- Females of child-bearing potential must be negative for pregnancy test at baseline and are able to practice effective contraception during the study period including the follow-up period
- Virile males and females of childbearing potential, who and whose partners consented to practice contraception throughout the study period after receiving an explanation using the informed consent form and the separately-prepared assent form
- Patients whose legally acceptable representatives (caregivers) are able to consent in writing to participate in the study and who are able to adhere to the protocol requirements. For patients aged 12 years or older at the time of informed consent, written consent should be obtained from the patients as well as their legally acceptable representatives (caregivers). Also for patients aged below 12 years, written informed consent should be obtained whenever possible.
Who cannot join
- Use of biological products which may affect the pathological evaluation of AD within 6 months before the start of study treatment
- Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period, except hydrocortisone butyrate preparations used in areas which are unsuitable for application of study drug at the discretion of the investigator
- Currently has Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo contagious, psoriasis, connective tissue disorder, or Netherton's syndrome, etc, which may affect the pathological evaluation of AD
- Any past history or present illness of serious allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction, or any past history or present illness of drug allergic reaction or hypersensitivity
- Has active infection that requires oral or intravenous administration of antibiotics, antifungal or antivirus agents at baseline
- Currently has an advanced disease or highly abnormal laboratory test result that may affect the safety of subject or the implementation of the study
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- Difficulty in venous access for blood collection
- Any past history or present illness of malignant tumor, lymphoma, leukemia or lymphoproliferative disorder, except non-melanoma skin carcinoma (e.g., squamous cell carcinoma and basal cell carcinoma) which was completely removed and has not recurred or metastasized for at least 5 years
- Scheduled for surgery during the study
- Concurrently enrolled in another clinical study or used any investigational drug or device within 30 days before the date of informed consent
- Ineligible for participating in the study for other reasons, in the judgment of the investigator or subinvestigator
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Chitose-shi, Hokkaido
Study site
Eniwa-shi, Hokkaido
Study site
Sapporo, Hokkaido
About this study
This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.
- Conditions
- Atopic Dermatitis
- Being tested
- E6005 0.05%, Placebo, E6005 0.2%
- Keywords
- Dermatitis, Atopic, Pediatric, Adolescent, Child
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6005 0.05%Drug
PlaceboDrug
0.5 g placebo ointment
E6005 0.2%Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | E6005 0.2% ointment applied twice a day to eczema areas Receives: Drug: E6005 0.2% |
| 2 | Experimental | E6005 0.05% ointment applied twice a day to eczema areas Receives: Drug: E6005 0.05% |
| 3 | Placebo comparator | Placebo ointment applied twice a day to eczema areas Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of E6005
The whole blood concentrations of E6005 and major metabolite will be evaluated at each visit
Measured: Up to 21 Days
Number of participants with adverse events as a measure of the safety and tolerability of E6005
The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results.
Measured: Up to 21 Days
Secondary outcomes (3)
Change from Baseline in severity score of targeted eczema
For targeted eczema defined at baseline, intensity of 4 symptoms (erythema, infiltration/papulation, excoriation, and lichenification) will be assessed using a 5-grade scoring method (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) (maximal score: 16).
Measured: Baseline and Day 15
Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites
Severity of AD dermal symptoms in targeted eczema and whole application sites wil be assessed based on a 6-grade scoring method (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe, 5: most severe).
Measured: Baseline and Day 15
Change from Baseline in intensity of pruritus
- Interview-based pruritus scores: Subjects or caregivers (who must not be changed throughout the study) will assess the intensity of pruritus day and night within 3 days before the visit. 2) Investigator-assessed pruritus: The investigator will assess pruritus conditions by grading into 5 levels (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) based on the comprehensive judgments of interview and scratching behaviors.
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJan 2015
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094235
- Sponsor's protocol ID
- E6005-J081-102
- Status last verified
- Feb 2018
- First submitted
- 20 Mar 2014
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02094235
- Acronym / sponsor ID
- E6005-J081-102
- Conditions
- Atopic Dermatitis
- Keywords
- Dermatitis, Atopic, Pediatric, Adolescent, Child
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Mar 2014 (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 is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E6005 0.2%E6005 0.2% ointment applied twice a day to eczema areas |
| 2 | Experimental | Drug: E6005 0.05%E6005 0.05% ointment applied twice a day to eczema areas |
| 3 | Placebo comparator | Drug: PlaceboPlacebo ointment applied twice a day to eczema areas |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Pediatric out-patients diagnosed with AD aged 2 to 15 years at the time of written informed consent. Diagnosis for AD should be made in accordance with the "Guidelines for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
- Mild to moderate clinical symptoms appearing at baseline in areas where the application of study drug is possible, except the skin of face/head and non-dermal areas such as mucosa
- Evaluable skin lesions appearing at baseline. "Evaluable skin lesion" means rash area of 25 to 100 cm2 in the trunk or extremities, in which at least one of dermal symptoms (erythema, exudate/eschar, excoriation or lichenification) must be moderate in severity.
- Continuous use of an appropriate moisturizer for at least 14 days before baseline
- Females of child-bearing potential must be negative for pregnancy test at baseline and are able to practice effective contraception during the study period including the follow-up period
Key exclusion criteria (11 listed)
- Use of biological products which may affect the pathological evaluation of AD within 6 months before the start of study treatment
- Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period, except hydrocortisone butyrate preparations used in areas which are unsuitable for application of study drug at the discretion of the investigator
- Currently has Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo contagious, psoriasis, connective tissue disorder, or Netherton's syndrome, etc, which may affect the pathological evaluation of AD
- Any past history or present illness of serious allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction, or any past history or present illness of drug allergic reaction or hypersensitivity
- Has active infection that requires oral or intravenous administration of antibiotics, antifungal or antivirus agents at baseline
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 |
|---|---|---|
| E6005 0.05% | Drug | 2 |
| Placebo0.5 g placebo ointment | Drug | 3 |
| E6005 0.2% | Drug | 1 |
Primary outcome
Pharmacokinetics of E6005
Time frame: Up to 21 Days
The whole blood concentrations of E6005 and major metabolite will be evaluated at each visit
Number of participants with adverse events as a measure of the safety and tolerability of E6005
Time frame: Up to 21 Days
The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results.
3 secondary outcomes
Change from Baseline in severity score of targeted eczema
Time frame: Baseline and Day 15
Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites
Time frame: Baseline and Day 15
Change from Baseline in intensity of pruritus
Time frame: Baseline and Day 15
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 4 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing E6005 0.05% and E6005 0.2% in people with Atopic Dermatitis, run by Organon and Co at 3 sites in Japan.
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 7 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetics of E6005 (time frame: Up to 21 Days). The study lists 2 primary outcomes in all. 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 4 Jun 2025.