PsoriasisPhase 1/2NCT02432027
Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test
A Phase 1/2 study testing C-82 Topical Gel, 1%, Daivonex cream and Diprosis gel in people with Psoriasis, run by Prism Pharma Co., Ltd. at 1 site in Germany.
Trial summary
Evaluate the effects of topical C-82 in a psoriasis plaque test. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psoriasis
- What is being tested?
- C-82 Topical Gel, 1%, Daivonex cream and Diprosis gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Sep 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate chronic stable plaque type psoriasis
- plaques thickness of at least 200 µm
- lesion(s) on the trunk or extremities (excluding palms/soles)
- skin must be without disease findings
Who cannot join
- other skin disease
- psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
- treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
- treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
- treatment with any biologics within 3 months preceding and during the trial
- known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol)
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- drug or alcohol abuse
- symptoms of a clinically significant illness within 4 preceding and during the trial
- participation another clinical trial within 4 weeks of this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test
Evaluate the effects of topical C-82 in a psoriasis plaque test.
Read the detailed description
The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.
- Conditions
- Psoriasis
- Being tested
- C-82 Topical Gel, Placebo, C-82 Topical Gel, 1%, Daivonex cream, Diprosis gel
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-82 Topical Gel, PlaceboDrug
placebo
C-82 Topical Gel, 1%Drug
active
Daivonex creamDrug
Also called calcipotriol 50mcg/g
comparator
Diprosis gelDrug
Also called betamethasone, 0.5 mg/g
comparator
| Study group | Role | What they receive |
|---|---|---|
| IMP 1 | Experimental | C-82 Topical Gel, 1% Receives: Drug: C-82 Topical Gel, 1% |
| IMP 2 | Placebo comparator | C-82 Topical Gel, placebo Receives: Drug: C-82 Topical Gel, Placebo |
| IMP 3 | Active comparator | Daivonex cream Receives: Drug: Daivonex cream |
| IMP 4 | Active comparator | Diprosis gel Receives: Drug: Diprosis gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate
Measured: day 12
Secondary outcomes (2)
antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.
Measured: Day 8 & Day 12
number of subjects with adverse events
Measured: daily through Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionSep 2015
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prism Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Theis, MD, Principal investigator, Klinische Forschung Schwerin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432027
- Sponsor's protocol ID
- PRI-C-82T-2101
- Status last verified
- Oct 2015
- First submitted
- 28 Apr 2015
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT02432027
- Acronym / sponsor ID
- PRI-C-82T-2101
- Conditions
- Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Prism Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 May 2015 (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.
Evaluate the effects of topical C-82 in a psoriasis plaque test.
Detailed description
The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IMP 1 | Experimental | Drug: C-82 Topical Gel, 1%C-82 Topical Gel, 1% |
| IMP 2 | Placebo comparator | Drug: C-82 Topical Gel, PlaceboC-82 Topical Gel, placebo |
| IMP 3 | Active comparator | Drug: Daivonex creamDaivonex cream |
| IMP 4 | Active comparator | Drug: Diprosis gelDiprosis gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mild to moderate chronic stable plaque type psoriasis
- plaques thickness of at least 200 µm
- lesion(s) on the trunk or extremities (excluding palms/soles)
- skin must be without disease findings
Key exclusion criteria (9 listed)
- other skin disease
- psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
- treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
- treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
- treatment with any biologics within 3 months preceding and during the trial
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 |
|---|---|---|
| C-82 Topical Gel, Placeboplacebo | Drug | IMP 2 |
| C-82 Topical Gel, 1%active | Drug | IMP 1 |
| Daivonex creamAlso: calcipotriol 50mcg/gcomparator | Drug | IMP 3 |
| Diprosis gelAlso: betamethasone, 0.5 mg/gcomparator | Drug | IMP 4 |
Primary outcome
antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate
Time frame: day 12
2 secondary outcomes
antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.
Time frame: Day 8 & Day 12
number of subjects with adverse events
Time frame: daily through Day 12
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 17 Aug 2017.
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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.
Elisabeth Theis, MD principal investigator
Klinische Forschung Schwerin GmbH
1 site 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 C-82 Topical Gel, 1%, Daivonex cream and Diprosis gel in people with Psoriasis, run by Prism Pharma Co., Ltd. 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 4 inclusion and 9 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 17 Aug 2017. 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 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?
antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate (time frame: day 12). 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 17 Aug 2017.