Scalp PsoriasisPhase 2NCT01914627
Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis
A Phase 2 study testing Dimethicone and Salicylic Acid in people with Scalp Psoriasis, run by G. Pohl-Boskamp GmbH & Co. KG at 1 site in Germany.
Trial summary
The study will be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Dimethicone and Salicylic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Having a diagnosis of chronic psoriasis capitis (scalp psoriasis) with or without the involvement of other body areas and with or without psoriatic arthritis.
- PSSI ≥5 (range 0-72)
- Scaling ≥2 (on an scale from 0 to 4)
- At least 10% of scalp area affected
- If a women:
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- Postmenopausal
- Premenopausal and using an established oral, injected or implanted hormonal method of contraception, intrauterine device (IUD) or intrauterine system (IUS)
- Negative pregnancy test at inclusion
- Patients with no concomitant systemic psoriasis medication.
- Willingness and adherence to the prohibitions and restrictions specified in the study protocol.
- Willingness to self-administer the drug.
- Signed informed consent document indicating that the patient to be included understands the purpose of and the procedures for the study and is willing to participate.
Who cannot join
- Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular).
- Patients with uncontrolled psoriasis under the current treatment.
- Patients having received topical keratolytic agents for the scalp within the past 2 weeks and topical steroids for the scalp within the past week (prior to inclusion).
- Patients receiving systemic antipsoriatic drugs, immunosuppressants or systemic corticosteroids (within 4 weeks prior to inclusion).
- Women who are pregnant or breastfeeding or planning to become pregnant during the observational period.
- Patients participating in another study using an investigational agent or procedure during participation in the study observation period.
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- Known hypersensitivity to any ingredient in the investigational products' formulations.
- Having any condition that in the opinion of the investigator makes the participation not be in the best interest of the subject.
- Employees and staff of the investigator or study site with direct involvement in the study as well as family members of the employee or the investigator.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, 20246
About this study
Official title: A Single-centre Randomised, Active-controlled, Observer-blinded, Parallel Group Trial to Evaluate the Efficacy and Safety of a Topical Dimeticone Formulation (Loion®) Compared to 10% Salicylic Acid in the Removal of Scaling in Patients With Chronic Psoriasis Capitis
The study will be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis).
- Conditions
- Scalp Psoriasis
- Being tested
- Dimethicone, Salicylic Acid
- Keywords
- Psoriasis capitis, Scaling, Salicylic acid, Dimethicone, Plaque removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimethiconeDrug
The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.
Salicylic AcidDrug
The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.
| Study group | Role | What they receive |
|---|---|---|
| Loion | Experimental | Not described Receives: Drug: Dimethicone |
| SA-Gel | Active comparator | Not described Receives: Drug: Salicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Scaling
To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis
Measured: at Day 7
Secondary outcomes (1)
Psoriasis Scalp Severity Index (PSSI)
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
Measured: at Day 0, day 3, day 7, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Pohl-Boskamp GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Matthias Augustin, Prof., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914627
- Sponsor's protocol ID
- 0741/179
- Status last verified
- Feb 2014
- First submitted
- 17 Jul 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Randomised, Active-controlled, Observer-blinded, Parallel Group Trial to Evaluate the Efficacy and Safety of a Topical Dimeticone Formulation (Loion®) Compared to 10% Salicylic Acid in the Removal of Scaling in Patients With Chronic Psoriasis Capitis
- ClinicalTrials.gov ID
- NCT01914627
- Acronym / sponsor ID
- 0741/179
- Conditions
- Scalp Psoriasis
- Keywords
- Psoriasis capitis, Scaling, Salicylic acid, Dimethicone, Plaque removal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- G. Pohl-Boskamp GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Aug 2013 (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 be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loion | Experimental | Drug: Dimethicone |
| SA-Gel | Active comparator | Drug: Salicylic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients ≥ 18 years of age
- Having a diagnosis of chronic psoriasis capitis (scalp psoriasis) with or without the involvement of other body areas and with or without psoriatic arthritis.
- PSSI ≥5 (range 0-72)
- Scaling ≥2 (on an scale from 0 to 4)
- At least 10% of scalp area affected
Key exclusion criteria (9 listed)
- Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular).
- Patients with uncontrolled psoriasis under the current treatment.
- Patients having received topical keratolytic agents for the scalp within the past 2 weeks and topical steroids for the scalp within the past week (prior to inclusion).
- Patients receiving systemic antipsoriatic drugs, immunosuppressants or systemic corticosteroids (within 4 weeks prior to inclusion).
- Women who are pregnant or breastfeeding or planning to become pregnant during the observational period.
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 |
|---|---|---|
| DimethiconeThe treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit. | Drug | Loion |
| Salicylic AcidThe treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit. | Drug | SA-Gel |
Primary outcome
Change from Baseline in Scaling
Time frame: at Day 7
To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis
1 secondary outcome
Psoriasis Scalp Severity Index (PSSI)
Time frame: at Day 0, day 3, day 7, day 14
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 5 Nov 2014.
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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.
Matthias Augustin, Prof. principal investigator
Universitätsklinikum Hamburg-Eppendorf
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 Dimethicone and Salicylic Acid in people with Scalp Psoriasis, run by G. Pohl-Boskamp GmbH & Co. KG 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 13 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 5 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 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. 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 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?
Change from Baseline in Scaling (time frame: at Day 7). 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 5 Nov 2014.