PsoriasisPhase 4NCT01356004
Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
A Phase 4 study testing live attenuated chicken pox vaccine and saline, efficacy in people with Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission. The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- live attenuated chicken pox vaccine and saline, efficacy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Nov 2010
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Severe psoriasis: At least 30% of body involved) according to the rule of nine.
- Resistance to conventional therapy (PUVA, methotrexate, retinoids):
- (Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).
- Immunologically competent individuals with
- Seropositive for the varicella antibodies
Who cannot join
- Any contraindication to live attenuated varicella vaccine
- Any contraindication to cyclosporine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial
Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission.
The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.
- Conditions
- Psoriasis
- Being tested
- live attenuated chicken pox vaccine, saline, efficacy
- Keywords
- severe resistant
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
live attenuated chicken pox vaccineDrug
Each immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months).
saline, efficacyDrug
4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
| Study group | Role | What they receive |
|---|---|---|
| chicken pox vaccine, efficacy | Experimental | Not described Receives: Drug: live attenuated chicken pox vaccine |
| saline, efficacy | Placebo comparator | Not described Receives: Drug: saline, efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with PASI score improvement as a Measure of effective treatment
the clinical evaluation of our patients through the Psoriasis Area Severity Index (PASI) score calculation at each visit.
The final patient's response was rated according to the physician global assessment (PGA) based on the final improvement of the PASI score as worse, poor (0-24% improvement in PASI), fair (25-50% improvement in PASI), good (50-74% improvement in PASI), excellent (75-99% improvement in PASI), or cleared (100% improvement in PASI).
Measured: 12 weeks
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionNov 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356004
- Sponsor's protocol ID
- CairoU
- Status last verified
- Jan 2011
- First submitted
- 17 May 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01356004
- Acronym / sponsor ID
- CairoU
- Conditions
- Psoriasis
- Keywords
- severe resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 May 2011 (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.
Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission.
The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chicken pox vaccine, efficacy | Experimental | Drug: live attenuated chicken pox vaccine |
| saline, efficacy | Placebo comparator | Drug: saline, efficacy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe psoriasis: At least 30% of body involved) according to the rule of nine.
- Resistance to conventional therapy (PUVA, methotrexate, retinoids):
- (Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).
- Immunologically competent individuals with
- Seropositive for the varicella antibodies
Key exclusion criteria (2 listed)
- Any contraindication to live attenuated varicella vaccine
- Any contraindication to cyclosporine
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 |
|---|---|---|
| live attenuated chicken pox vaccineEach immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months). | Drug | chicken pox vaccine, efficacy |
| saline, efficacy4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients | Drug | saline, efficacy |
Primary outcome
Number of Participants with PASI score improvement as a Measure of effective treatment
Time frame: 12 weeks
the clinical evaluation of our patients through the Psoriasis Area Severity Index (PASI) score calculation at each visit. The final patient's response was rated according to the physician global assessment (PGA) based on the final improvement of the PASI score as worse, poor (0-24% improvement in PASI), fair (25-50% improvement in PASI), good (50-74% improvement in PASI), excellent (75-99% improvement in PASI), or cleared (100% improvement in PASI).
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 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 19 May 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.
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 4 study testing live attenuated chicken pox vaccine and saline, efficacy 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 5 inclusion and 2 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 19 May 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.
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?
Number of Participants with PASI score improvement as a Measure of effective treatment (time frame: 12 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 19 May 2011.