PsoriasisPhase 2NCT01722812
Cromoglicate in Psoriasis
A Phase 2 study testing Cromoglicate in people with Psoriasis, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cromoglicate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent has been obtained
- Age 18 years or above
- Either sex
- Any race or ethnicity
- Attending hospital outpatient clinic or the private practice of a dermatologist
- Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric distribution
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- Two treatment areas with a symmetrical distribution each corresponding to 2-3% BSA (Body Surface Area) and each including at least one itchy psoriasis plaque
- Itchy psoriasis on both intended treatment areas of at least 40mm on the Visual Analogue Scale (VAS) with a maximum difference of 10mm on the visual analogue scale between each of the two treatment areas
- Disease severity graded mild, moderate or severe according to the Physician's global assessment (PGA) of disease severity on psoriasis plaques on each of the two treatment areas. The disease severity must be the same for both treatment areas
Who cannot join
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- etanercept - within 4 weeks prior to randomisation
- adalimumab, infliximab - within 8 weeks prior to randomisation
- ustekinumab - within 16 weeks prior to randomisation
- other products - 4 weeks/5 half-lives (whichever is longer)
- Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
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- Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
- Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
- antihistamines - within 1 week prior to randomisation
- gabapentin - within 4 weeks prior to randomisation
- Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer treatment free period as defined in exclusion criterion 1 for biological treatments
- PUVA (Psoralen and Ultraviolet A Radiation) or Grenz ray therapy within 4 weeks prior to randomisation.
- UVB therapy within 2 weeks prior to randomisation
- Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
- Subjects with current participation in any other interventional clinical trial
- Subjects with any of the following conditions present on the treatment areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds
- Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis
- Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investigational products or formulations being tested
- Known or suspected severe renal insufficiency or severe hepatic disorders
- Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
- Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoided)
- Subjects previously randomised into this trial
- Not all of the exclusion criteria listed due to limited space
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: An Exploratory Study Evaluating the Efficacy of Cromoglicate Cream Compared to Cream Vehicle in the Treatment of Itch in Psoriasis
The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
- Conditions
- Psoriasis
- Being tested
- Cromoglicate, Placebo
- Medical subject headings
- Psoriasis
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 on left body side), Cromoglicate (on a lesion on right body side) Receives: Drug: Placebo |
| Placebo (right) / Cromoglicate (left) | Other | Placebo (on a lesion on right body side), Cromoglicate (on a lesion on left body side) Receives: Drug: Cromoglicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change in visual analogue scale
Measured: Baseline to week 2
Secondary outcomes (1)
Evaluation of change in 4-point itch scale, 7-point itch scale, duration of itch and comparison of treated areas
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 posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722812
- Sponsor's protocol ID
- LP0075-34
- Status last verified
- Apr 2022
- First submitted
- 5 Nov 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
- An Exploratory Study Evaluating the Efficacy of Cromoglicate Cream Compared to Cream Vehicle in the Treatment of Itch in Psoriasis
- ClinicalTrials.gov ID
- NCT01722812
- Acronym / sponsor ID
- LP0075-34
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Nov 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 cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
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: PlaceboPlacebo (on a lesion on left body side), Cromoglicate (on a lesion on right body side) |
| Placebo (right) / Cromoglicate (left) | Other | Drug: CromoglicatePlacebo (on a lesion on right body side), Cromoglicate (on a lesion on left body side) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent has been obtained
- Age 18 years or above
- Either sex
- Any race or ethnicity
- Attending hospital outpatient clinic or the private practice of a dermatologist
Key exclusion criteria (23 listed)
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
- Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
- Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
- Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer treatment free period as defined in exclusion criterion 1 for biological treatments
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 (right) / Cromoglicate (left) |
| PlaceboTwice daily topical treatment for 14 days | Drug | Placebo (left) / Cromoglicate (right) |
Primary outcome
Evaluation of change in visual analogue scale
Time frame: Baseline to week 2
1 secondary outcome
Evaluation of change in 4-point itch scale, 7-point itch scale, duration of itch and comparison of treated areas
Time frame: Baseline to week 2
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 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psoriasis, 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 9 inclusion and 23 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 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 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?
Evaluation of change in visual analogue scale (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.