PsoriasisNCT01133561
Pioglitazone in Psoriasis- A Clinical and Molecular Study.
A study testing actozone A and actozone B in people with Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis. The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- actozone A and actozone B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Aug 2010
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and less than 65 years.
- Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).
Who cannot join
- Age less than 18 years and more than 65 years
- Mild psoriasis less than 10% body surface area
- Erythrodermic or pustular psoriasis
- Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.
- Pregnant and lactating females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology department of cairo university faculty of medicine
Cairo
About this study
Official title: The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT
The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.
The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.
- Conditions
- Psoriasis
- Being tested
- actozone A, actozone B
- Keywords
- psoriasis, insulin resistance, metabolic syndrome, pioglitazone, randomized control trial
- Medical subject headings
- Psoriasis, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actozone ADrug
pioglitazone 30 mg tablet , once daily dose for 10 weeks
actozone BDrug
one tablet of vehicle without active ingredient pioglitazone
| Study group | Role | What they receive |
|---|---|---|
| actozone A | Active comparator | Pioglitazone 30 mg tablets daily Receives: Drug: actozone A |
| actozone B | Placebo comparator | placebo Receives: Drug: actozone B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success detected as clinical improvement of skin condition
PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50
Measured: 10 weeks
Secondary outcomes (2)
Fasting serum insulin reduction from baseline before treatment
Measured: 10 weeks
C-reactive protein titre reduction from baseline value before treatment
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionAug 2010
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Investigators
- Manal AW Bosseila, MD, Study chair, Cairo University-Dermatology departmentMona RE Abdel Halim, MD, Study director, Cairo university- Dermatology departmentMohamed I Sheta, MD, Study director, Cairo university- Internal medicine departmentOlfat G Shaker, MD, Study director, Cairo University- Biochemistry department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133561
- Sponsor's protocol ID
- VHafez 2010
- Status last verified
- Feb 2011
- First submitted
- 25 May 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT
- ClinicalTrials.gov ID
- NCT01133561
- Acronym / sponsor ID
- VHafez 2010
- Conditions
- Psoriasis
- Keywords
- psoriasis, insulin resistance, metabolic syndrome, pioglitazone, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 May 2010 (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 study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.
The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| actozone A | Active comparator | Drug: actozone APioglitazone 30 mg tablets daily |
| actozone B | Placebo comparator | Drug: actozone Bplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years and less than 65 years.
- Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).
Key exclusion criteria (5 listed)
- Age less than 18 years and more than 65 years
- Mild psoriasis less than 10% body surface area
- Erythrodermic or pustular psoriasis
- Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.
- Pregnant and lactating females.
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 |
|---|---|---|
| actozone Apioglitazone 30 mg tablet , once daily dose for 10 weeks | Drug | actozone A |
| actozone Bone tablet of vehicle without active ingredient pioglitazone | Drug | actozone B |
Primary outcome
Treatment success detected as clinical improvement of skin condition
Time frame: 10 weeks
PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50
2 secondary outcomes
Fasting serum insulin reduction from baseline before treatment
Time frame: 10 weeks
C-reactive protein titre reduction from baseline value before treatment
Time frame: 10 weeks
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 23 Feb 2011.
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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.
Manal AW Bosseila, MD study chair
Cairo University-Dermatology department
Mona RE Abdel Halim, MD study director
Cairo university- Dermatology department
Mohamed I Sheta, MD study director
Cairo university- Internal medicine department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing actozone A and actozone B in people with Psoriasis, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 5 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 23 Feb 2011. 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 Egypt. 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.
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?
Treatment success detected as clinical improvement of skin condition (time frame: 10 weeks). 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 23 Feb 2011.