Nail PsoriasisPhase 2NCT02235480
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
A Phase 2 study testing Experimental Tazarotene Gel in people with Nail Psoriasis, run by Almirall, S.A. at 4 sites in Germany.
Trial summary
The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Experimental Tazarotene Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 4 sitesGermany
- Study dates
- Feb 2014to May 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate nail psoriasis on at least one fingernail
Who cannot join
- any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
- history of hypersensitivity to retinoids or to other components of the trial medication
- topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;
- systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial
- intralesional steroid injection before the treatment phase of the trial
- phototherapy before the treatment phase of the trial;
Show all 11Show fewer
- any chronic infection or condition capable of interfering with the conduct of the trial;
- evidence of drug or alcohol abuse;
- symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial;
- participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
- pregnancy or nursing;
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Investigational site 3
Berlin
Investigational site 4
Berlin
Investigational 2
Hamburg
Investigational site 1
Hamburg
About this study
Official title: A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison
The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.
- Conditions
- Nail Psoriasis
- Being tested
- Experimental Tazarotene Gel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Tazarotene GelDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene Gel | Experimental | once daily Receives: Drug: Experimental Tazarotene Gel |
| Placebo Gel | Placebo comparator | once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
% reduction in the Nail Psoriasis Severity Index ( NAPSI )
Measured: Day85
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235480
- Sponsor's protocol ID
- H 573 000 1307
- Other IDs
- 2013-004519-28
- Status last verified
- Jun 2015
- First submitted
- 31 Mar 2014
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison
- ClinicalTrials.gov ID
- NCT02235480
- Acronym / sponsor ID
- H 573 000 1307
- Conditions
- Nail Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Sep 2014 (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 aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tazarotene Gel | Experimental | Drug: Experimental Tazarotene Gelonce daily |
| Placebo Gel | Placebo comparator | Drug: Placeboonce daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate nail psoriasis on at least one fingernail
Key exclusion criteria (11 listed)
- any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
- history of hypersensitivity to retinoids or to other components of the trial medication
- topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;
- systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial
- intralesional steroid injection before the treatment phase of the trial
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 |
|---|---|---|
| Experimental Tazarotene Gel | Drug | Tazarotene Gel |
| Placebo | Drug | Placebo Gel |
Primary outcome
% reduction in the Nail Psoriasis Severity Index ( NAPSI )
Time frame: Day85
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 85
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 10 Jun 2015.
Related trials for Nail Psoriasis
Not yet recruiting
Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail Psoriasis
Nail Psoriasis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
Active, not recruitingPhase 2
Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
Nail Psoriasis
Recruiting
Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
Nail Psoriasis
Active, not recruitingObservational study
Psorcast Mobile Study
Psoriatic Arthritis, Psoriasis
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental Tazarotene Gel in people with Nail Psoriasis, run by Almirall, S.A. at 4 sites 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 1 inclusion and 11 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 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 the Nail Psoriasis Severity Index ( NAPSI ) (time frame: Day85). 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 10 Jun 2015.