Inverse PsoriasisPhase 2NCT01574872
Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
A Phase 2 study testing Halotherapy in people with Inverse Psoriasis and Sebopsoriasis, run by Tecno Sun SRL at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inverse Psoriasis, Sebopsoriasis
- What is being tested?
- Halotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inverse Psoriasis or Sebopsoriasis lasting from at one year
- At least 1% of total body surface area involvement Suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
Who cannot join
- Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure
- Iodine allergy
- Women who are pregnant or planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year
- Conditions
- Inverse Psoriasis, Sebopsoriasis
- Being tested
- Halotherapy, Placebo
- Keywords
- psoriasis, salt, sodium chloride
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalotherapyDevice
Also called aerosal, salt, sodium chloride
The treatment consist of 15 session of micronized iodized salt (sodium chloride) skin exposure in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.
PlaceboDevice
Also called comparator
The treatment consist of 15 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aerosal | Experimental | This arm include all patients treated with Aerosal® Receives: Device: Halotherapy |
| Placebo | Placebo comparator | This arm include all patients treated with placebo Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
Measured: 3 weeks (15 sessions), 15 weeks
Secondary outcomes (4)
Any change from baseline of physician's clinical judgment
Any change from baseline of physician's clinical judgment as assessed by visual analogue scale (VAS)
Measured: 3 weeks (15 sessions), 15 weeks
Overall patient satisfaction
Overall patient satisfaction as assessed by visual analogue scale VAS
Measured: 3 weeks (15 sessions), 15 weeks
Any change from baseline of PASI index
Measured: 3 weeks (15 sessions), 15 weeks
Number of reported adverse events
Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it
Measured: 3 weeks (15 sessions), 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013 (estimated)
- Study completionApr 2013 (estimated)
Why it stopped: Changes in the sponsorship, design and locations of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inverse 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecno Sun SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Studi Gised
- Responsible party
- Sponsor
- Investigators
- Luigi Naldi, MD, Principal investigator, Centro Studi Gised
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574872
- Sponsor's protocol ID
- AEROSAL1
- Status last verified
- Nov 2014
- First submitted
- 6 Apr 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
- ClinicalTrials.gov ID
- NCT01574872
- Acronym / sponsor ID
- AEROSAL1
- Conditions
- Inverse Psoriasis, Sebopsoriasis
- Keywords
- psoriasis, salt, sodium chloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in the sponsorship, design and locations of the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tecno Sun SRLIndustry (pharma, biotech, devices)
- Collaborators
- Centro Studi Gised
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 10 Apr 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 study is to evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosal | Experimental | Device: HalotherapyThis arm include all patients treated with Aerosal® |
| Placebo | Placebo comparator | Device: PlaceboThis arm include all patients treated with placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inverse Psoriasis or Sebopsoriasis lasting from at one year
- At least 1% of total body surface area involvement Suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
Key exclusion criteria (3 listed)
- Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure
- Iodine allergy
- Women who are pregnant or planning to become pregnant during the study
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 |
|---|---|---|
| HalotherapyAlso: aerosal, salt, sodium chlorideThe treatment consist of 15 session of micronized iodized salt (sodium chloride) skin exposure in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes. | Device | Aerosal |
| PlaceboAlso: comparatorThe treatment consist of 15 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes. | Device | Placebo |
Primary outcome
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
Time frame: 3 weeks (15 sessions), 15 weeks
4 secondary outcomes
Any change from baseline of physician's clinical judgment
Time frame: 3 weeks (15 sessions), 15 weeks
Overall patient satisfaction
Time frame: 3 weeks (15 sessions), 15 weeks
Any change from baseline of PASI index
Time frame: 3 weeks (15 sessions), 15 weeks
Number of reported adverse events
Time frame: 3 weeks (15 sessions), 15 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
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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.
Luigi Naldi, MD principal investigator
Centro Studi Gised
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 Halotherapy in people with Inverse Psoriasis and Sebopsoriasis, run by Tecno Sun SRL at 1 site in Italy.
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 3 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: withdrawn, as of the sponsor's last update on 18 Nov 2014. 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 Italy. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) (time frame: 3 weeks (15 sessions), 15 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 18 Nov 2014.