Atopic DermatitisPhase 1CT327 AD01-09NCT01368315
CT 327 in the "Atopy Patch Test" Model
A Phase 1 study testing CT327 application and Active comparator in people with Atopic Dermatitis, run by Creabilis SA at 1 site in Germany.
Trial summary
A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CT327 application and Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 66 years of age
- Able to give informed consent
- Diagnosis of atopic dermatitis and a positive atopy patch test to at least one of the following(Dermaphagoides pteronyssinus, cat dander, grass or birch pollen)
Who cannot join
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Have a positive response to petrolatum
- Be immune-compromised
- Have any clinically significant abnormal clinical laboratory test results at Screening
- Have a history of malignancy except basal cell carcinoma of the skin.
- Have an active intercurrent infection
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- Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 14 days prior to study entry.
- Have received antibiotic treatment within 1 week prior to study entry
- Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
- Have received any investigational drug or been part of any clinical study within the last three months before study entry.
- Have a history of hypersensitivity or allergic reactions to any ingredient in the CT 327 formulation or to the selected active comparator or to polyethyleneglycol.
- If female, are pregnant or lactating, or intend to become pregnant during the study period
- If female, and of child-bearing potential, not taking adequate contraception to avoid pregnancy during and three months after the study.
- History of drug, alcohol or other substance abuse or other factors limiting the ability to cooperate and to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein Technische Universität München
Munich, D-80802
About this study
A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.
Read the detailed description
The study population will include subjects with atopic dermatitis (AD) and a positive atopy patch test (APT) test at study screening. Positive responders to the APT test will enter into a treatment period of ten days during which all subjects will have three test compounds (CT 327, Placebo or an active comparator) administered twice daily to three test fields marked on patient's back. A fourth test field will act as untreated control. A challenge with the relevant aeroallergen to which the subject is responding most strongly, as assessed at screening, will take place on Day 10. Readings of APT scores will be performed at 48 and 72 hrs after the challenge and the subjects will have a end-of-study visit 2 weeks later. Local and systemic tolerance of CT327 will be assessed during the study, in addition to its potential absorption into the systemic circulation. The effects of CT327 on modulating the immune response to aeroallergens and on the expression of immunological and inflammatory markers on biopsies of the treated areas will also be evaluated.
- Conditions
- Atopic Dermatitis
- Being tested
- CT327 application, Placebo, Active comparator, No intervention
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT327 applicationDrug
Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.
PlaceboDrug
Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.
Active comparatorDrug
Topical administration of an active comparator administered twice daily for ten days to one out of four test fields marked on the patient's back.
No interventionDrug
No intervention to one out of four test fields marked on the patient's back.
| Study group | Role | What they receive |
|---|---|---|
| CT327 | Experimental | Cream Receives: Drug: CT327 application |
| Placebo | Placebo comparator | Cream (Vehicle only) Receives: Drug: Placebo |
| Active comparator | Active comparator | Cream Receives: Drug: Active comparator |
| No intervention | No intervention | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria
Measured: 13 days
Secondary outcomes (2)
Local and systemic tolerance of CT 327
Measured: 7 weeks
Plasma CT327 levels
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
Why it stopped: Strategic decision
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creabilis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Dr. Med. Johannes Ring, Principal investigator, Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein, Technische Universität München, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368315
- Sponsor's protocol ID
- CT 327 AD 01-09
- Acronym
- CT327 AD01-09
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT 327 in the "Atopy Patch Test" Model
- ClinicalTrials.gov ID
- NCT01368315
- Acronym / sponsor ID
- CT327 AD01-09 / CT 327 AD 01-09
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic decision
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Creabilis SAIndustry (pharma, biotech, devices)
- First posted
- 7 Jun 2011 (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.
A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.
Detailed description
The study population will include subjects with atopic dermatitis (AD) and a positive atopy patch test (APT) test at study screening. Positive responders to the APT test will enter into a treatment period of ten days during which all subjects will have three test compounds (CT 327, Placebo or an active comparator) administered twice daily to three test fields marked on patient's back. A fourth test field will act as untreated control. A challenge with the relevant aeroallergen to which the subject is responding most strongly, as assessed at screening, will take place on Day 10. Readings of APT scores will be performed at 48 and 72 hrs after the challenge and the subjects will have a end-of-study visit 2 weeks later. Local and systemic tolerance of CT327 will be assessed during the study, in addition to its potential absorption into the systemic circulation. The effects of CT327 on modulating the immune response to aeroallergens and on the expression of immunological and inflammatory markers on biopsies of the treated areas will also be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT327 | Experimental | Drug: CT327 applicationCream |
| Placebo | Placebo comparator | Drug: PlaceboCream (Vehicle only) |
| Active comparator | Active comparator | Drug: Active comparatorCream |
| No intervention | No intervention | Drug: No intervention |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 and < 66 years of age
- Able to give informed consent
- Diagnosis of atopic dermatitis and a positive atopy patch test to at least one of the following(Dermaphagoides pteronyssinus, cat dander, grass or birch pollen)
Key exclusion criteria (14 listed)
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Have a positive response to petrolatum
- Be immune-compromised
- Have any clinically significant abnormal clinical laboratory test results at Screening
- Have a history of malignancy except basal cell carcinoma of the skin.
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 |
|---|---|---|
| CT327 applicationTopical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back. | Drug | CT327 |
| PlaceboTopical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back. | Drug | Placebo |
| Active comparatorTopical administration of an active comparator administered twice daily for ten days to one out of four test fields marked on the patient's back. | Drug | Active comparator |
| No interventionNo intervention to one out of four test fields marked on the patient's back. | Drug | No intervention |
Primary outcome
Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria
Time frame: 13 days
2 secondary outcomes
Local and systemic tolerance of CT 327
Time frame: 7 weeks
Plasma CT327 levels
Time frame: 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
Prof. Dr. Med. Johannes Ring principal investigator
Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein, Technische Universität München, Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT327 application and Active comparator in people with Atopic Dermatitis, run by Creabilis SA 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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 7 Jun 2011. 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. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria (time frame: 13 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 7 Jun 2011.