MastocytosisPhase 2NCT01701843
Cromoglicate in Mastocytosis
A Phase 2 study testing Cromoglicate in people with Mastocytosis, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mastocytosis
- What is being tested?
- Cromoglicate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Feb 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent has been obtained
- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
- Age between 18 and 70 years
- Either sex
- Any race or ethnicity
- Attending hospital outpatient clinic or the private practice of a dermatologist.
Who cannot join
- The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
- Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
- Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)
- Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value)
- Presence of active cancer which requires chemotherapy or radiation therapy
Show all 20Show fewer
- Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
- Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
- Intake of oral corticosteroids within 14 days prior to randomisation
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
- Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
- Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas
- Known or suspected hypersensitivity to component(s) of investigational products.
- Current participation in any other interventional clinical trial.
- Subjects who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
- Previously randomised in this clinical trial
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
- Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
- Females of child-bearing potential with positive pregnancy test at visit 1.
- Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin
Berlin, D-10117
About this study
Official title: A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis
The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.
- Conditions
- Mastocytosis
- Being tested
- Cromoglicate, Placebo
- Medical subject headings
- Mastocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CromoglicateDrug
Twice daily topical treatment for 14 days
PlaceboDrug
Twice daily topical treatment for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo (left) / Cromoglicate (right) | Other | Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside) Receives: Drug: Cromoglicate; Drug: Placebo |
| Placebo (right) / Cromoglicate (left) | Other | Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside) Receives: Drug: Cromoglicate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of mechanically induced changes of lesions
Measured: Baseline to week 2
Secondary outcomes (1)
Evaluation of mechanically induced wheal and flare response
Measured: Baseline to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: prematurely terminated because of low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Siebenhaar, MD, Principal investigator, Allergie-Centrum-Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701843
- Sponsor's protocol ID
- LP0074-33
- Status last verified
- Mar 2013
- First submitted
- 11 Jul 2012
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis
- ClinicalTrials.gov ID
- NCT01701843
- Acronym / sponsor ID
- LP0074-33
- Conditions
- Mastocytosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: prematurely terminated because of low recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Oct 2012 (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 purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (left) / Cromoglicate (right) | Other | Drug: Cromoglicate, Drug: PlaceboPlacebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside) |
| Placebo (right) / Cromoglicate (left) | Other | Drug: Cromoglicate, Drug: PlaceboPlacebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent has been obtained
- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
- Age between 18 and 70 years
- Either sex
- Any race or ethnicity
Key exclusion criteria (20 listed)
- The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
- Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
- Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)
- Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value)
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 |
|---|---|---|
| CromoglicateTwice daily topical treatment for 14 days | Drug | Placebo (left) / Cromoglicate (right), Placebo (right) / Cromoglicate (left) |
| PlaceboTwice daily topical treatment for 14 days | Drug | Placebo (left) / Cromoglicate (right), Placebo (right) / Cromoglicate (left) |
Primary outcome
Evaluation of mechanically induced changes of lesions
Time frame: Baseline to week 2
1 secondary outcome
Evaluation of mechanically induced wheal and flare response
Time frame: Baseline to week 2
Results and safety
The study was stopped early (reason given: prematurely terminated because of low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Frank Siebenhaar, MD principal investigator
Allergie-Centrum-Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cromoglicate in people with Mastocytosis, run by LEO Pharma 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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 24 Feb 2025. 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.
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 was stopped early (reason given: prematurely terminated because of low recruitment). Results are not available in the source record.
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?
Evaluation of mechanically induced changes of lesions (time frame: Baseline to week 2). 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 24 Feb 2025.