PsoriasisPhase 4NCT00763529
Elocon vs Fluticasone in Localized Psoriasis (P03197)
A Phase 4 study testing Mometasone and Fluticasone in people with Psoriasis, run by Organon and Co.
Trial summary
This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Mometasone and Fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 1 Jan 2005
- Phase
- Phase 4
- 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
- >=18 years of age
- Written informed consent
- Having localized psoriasis (not more than 5-6 patches)
- Total size of all patches should be below 8" x 8"
- Each patient should exhibit any of the following 4 signs of dermatoses:
- erythema
Show all 14Show fewer
- palpability
- scaling
- itching (pruritus)
- Each of the above signs would be grades according to the following scale:
- 0 = none
- = slight
- = moderate
- = severe The total Disease Severity Score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status)
Who cannot join
- Pregnancy or lactation
- Hypersensitivity to any of the components of the test medication
- Signs of atrophy in the target area
- Lesions on palms, soles, and scalp
- Individuals who may require medications that might affect the natural course of the disease
- Not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study
- Concomitant tuberculosis/viral infection
About this study
Official title: Elocon vs Fluticasone in Localized Psoriasis
This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.
- Conditions
- Psoriasis
- Being tested
- Mometasone, Fluticasone
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MometasoneDrug
Also called Elocon, SCH 32088
Mometasone furoate cream 0.1% applied once daily
FluticasoneDrug
Also called Cutivate
Fluticasone propionate cream 0.05% applied twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Mometasone |
| Arm 2 | Active comparator | Not described Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.
Measured: Day 4
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8.
Measured: Day 8
Clinical evaluation of the change in disease status which would be defined as improvement by Day 4 relative to their severity at entry in treated areas.
Measured: Day 4
Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas.
Measured: Day 8
Secondary outcomes (6)
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.
Measured: Day 15
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.
Measured: Day 22
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.
Measured: Day 29
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.
Measured: Day 15
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.
Measured: Day 22
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study start1 Jan 2003
- Primary completion1 Jan 2005
- Study completion1 Jan 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763529
- Sponsor's protocol ID
- P03197
- Status last verified
- Feb 2022
- First submitted
- 29 Sep 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elocon vs Fluticasone in Localized Psoriasis
- ClinicalTrials.gov ID
- NCT00763529
- Acronym / sponsor ID
- P03197
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Jan 2005 (actual)
- Study completion
- 1 Jan 2005 (actual)
- First posted
- 1 Oct 2008 (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.
This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Mometasone |
| Arm 2 | Active comparator | Drug: Fluticasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- >=18 years of age
- Written informed consent
- Having localized psoriasis (not more than 5-6 patches)
- Total size of all patches should be below 8" x 8"
- Each patient should exhibit any of the following 4 signs of dermatoses:
Key exclusion criteria (7 listed)
- Pregnancy or lactation
- Hypersensitivity to any of the components of the test medication
- Signs of atrophy in the target area
- Lesions on palms, soles, and scalp
- Individuals who may require medications that might affect the natural course of the disease
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 |
|---|---|---|
| MometasoneAlso: Elocon, SCH 32088Mometasone furoate cream 0.1% applied once daily | Drug | Arm 1 |
| FluticasoneAlso: CutivateFluticasone propionate cream 0.05% applied twice daily | Drug | Arm 2 |
Primary outcome
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.
Time frame: Day 4
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8.
Time frame: Day 8
Clinical evaluation of the change in disease status which would be defined as improvement by Day 4 relative to their severity at entry in treated areas.
Time frame: Day 4
Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas.
Time frame: Day 8
6 secondary outcomes
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.
Time frame: Day 15
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.
Time frame: Day 22
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.
Time frame: Day 29
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.
Time frame: Day 15
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.
Time frame: Day 22
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.
Time frame: Day 29
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 15 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone and Fluticasone in people with Psoriasis, run by Organon and Co.
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 14 inclusion and 7 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4. (time frame: Day 4). The study lists 4 primary outcomes in all. 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 15 Aug 2024.