Cutaneous MastocytosisPhase 2NCT00457288
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
A Phase 2 study testing TF 002 in people with Cutaneous Mastocytosis, run by JADO Technologies GmbH at 4 sites in Germany.
Trial summary
The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Mastocytosis
- What is being tested?
- TF 002
- How many people
- 30 participants
- Where
- 4 sitesGermany
- Study dates
- Apr 2007to Sep 2007
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign
- 3 comparable skin lesional areas
- Otherwise healthy according to physical examination
- Informed consent signed and dated
Who cannot join
- Aggressive systemic mastocytosis
- Other dermatological diseases at treated skin site
- Known hypersensitivity to study drugs or their components
- Mental disorders
- Drug or alcohol dependency
- Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator's decision).
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- Immunodeficiency including HIV
- Pregnancy or lactation
- Participation in another clinical trial within the last 30 days
- Malignant skin lesions
- Radiation therapy of target areas excluding UV therapy longer then 4 weeks before start of study treatment
- Dermal comorbidities within the target areas
- Any concomitant medication which might influence the study objectives or are known to provoke or aggravate mastocytosis
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinik und Poliklinik für Dermatologie und Venerologie der Universität
Cologne, Köln, D-50924
Universitäts-Hautklinik
Mainz, D-55131
Klinik und Poliklinik für Dermatologie und Allergologie der LMU
München, D-80337
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
München, D-80802
About this study
The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on Darier´s signs and the histological evaluation of mast cell numbers in skin bioptic material.
Read the detailed description
This is a randomised, double-blind, placebo- and active-controlled study with intra-individual comparison of test areas.
The primary study target is to evaluate the safety and efficacy of TF002 for the treatment of cutaneous mastocytosis or systemic mastocytosis with skin involvment. The treatment period of 14 days was adjusted to the maximum recommended treatment period for the comparator Dermoxinale®.
Since there are no approved therapies for this indication a placebo controlled design was chosen.
There are some reports about transient treatment effects using high potent steroids like clobetasol in mastocytosis. This triggered the decision to use Dermoxinale® as positive control.
To validate the clinical scores used in the study, surrogate markers describing the Darier´s sign (thermography, volumetric test) will be evaluated optionally.
- Conditions
- Cutaneous Mastocytosis
- Being tested
- TF 002
- Keywords
- Cutaneous Mastocytosis, Topical treatment
- Medical subject headings
- Mastocytosis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF 002Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of treatment response
Secondary outcomes (2)
Number of skin mast cells
Volumetric and thermographic analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startApr 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MastocytosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JADO Technologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marcus Maurer, Prof, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457288
- Sponsor's protocol ID
- MICUMA
- Status last verified
- Nov 2007
- First submitted
- 4 Apr 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TF002 in Cutaneous Mastocytosis
- ClinicalTrials.gov ID
- NCT00457288
- Acronym / sponsor ID
- MICUMA
- Conditions
- Cutaneous Mastocytosis
- Keywords
- Cutaneous Mastocytosis, Topical treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- JADO Technologies GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Apr 2007 (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.
The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on Darier´s signs and the histological evaluation of mast cell numbers in skin bioptic material.
Detailed description
This is a randomised, double-blind, placebo- and active-controlled study with intra-individual comparison of test areas.
The primary study target is to evaluate the safety and efficacy of TF002 for the treatment of cutaneous mastocytosis or systemic mastocytosis with skin involvment. The treatment period of 14 days was adjusted to the maximum recommended treatment period for the comparator Dermoxinale®.
Since there are no approved therapies for this indication a placebo controlled design was chosen.
There are some reports about transient treatment effects using high potent steroids like clobetasol in mastocytosis. This triggered the decision to use Dermoxinale® as positive control.
To validate the clinical scores used in the study, surrogate markers describing the Darier´s sign (thermography, volumetric test) will be evaluated optionally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign
- 3 comparable skin lesional areas
- Otherwise healthy according to physical examination
- Informed consent signed and dated
Key exclusion criteria (13 listed)
- Aggressive systemic mastocytosis
- Other dermatological diseases at treated skin site
- Known hypersensitivity to study drugs or their components
- Mental disorders
- Drug or alcohol dependency
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 |
|---|---|---|
| TF 002 | Drug | – |
Primary outcome
Clinical evaluation of treatment response
2 secondary outcomes
Number of skin mast cells
Volumetric and thermographic analyses
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 12 Nov 2007.
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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.
Marcus Maurer, Prof principal investigator
Charite University, Berlin, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TF 002 in people with Cutaneous Mastocytosis, run by JADO Technologies GmbH 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 4 inclusion and 13 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 12 Nov 2007. 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.
What does this phase mean?
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?
Clinical evaluation of treatment response. 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 12 Nov 2007.