Nail PsoriasisPhase 4NCT03991936
Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
A Phase 4 study testing Triamcinolone Acetonide 2.5 mg/mL, Triamcinolone Acetonide 5.0 mg/mL and Triamcinolone Acetonide 7.5 mg/mL in people with Nail Psoriasis and Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis, Nail Diseases
- What is being tested?
- Triamcinolone Acetonide 2.5 mg/mL, Triamcinolone Acetonide 5.0 mg/mL and Triamcinolone Acetonide 7.5 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 29 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age
- Diagnosed with nail psoriasis in at least 2 fingernails
- Willing to give written informed consent and able to adhere to procedures and visit schedules
- Must consent to having the fingernails photographed during the study period
Who cannot join
- Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study. This is including, but not limited to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, allergy to triamcinolone acetonide, local anesthetic, normal saline, or any other material used for procedures
- Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 month within the 6 months of study (exception: inhaled steroids)
- Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study
- Subject who is unwilling to abstain from any cosmetic nail treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail treatments, no nail polish use, no other topical prescription nail medication)
- Subject who is unwilling to abstain from any medical nail treatments on their nails other than the study intervention (i.e. topical steroids, anti-fungal creams) for the duration of the study intervention and for duration of the washout period (if applicable)
- Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10021
About this study
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.
- Conditions
- Nail Psoriasis, Nail Diseases
- Being tested
- Placebos, Triamcinolone Acetonide 2.5 mg/mL, Triamcinolone Acetonide 5.0 mg/mL, Triamcinolone Acetonide 7.5 mg/mL, Triamcinolone Acetonide 10 mg/mL
- Keywords
- Nail Psoriasis, Nail Diseases, Triamcinolone acetonide, Triamcinolone
- Medical subject headings
- Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
Also called Saline solution for injection
Normal saline intralesional injection
Triamcinolone Acetonide 2.5 mg/mLDrug
Also called Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension
2.5 mg/mL intralesional injection
Triamcinolone Acetonide 5.0 mg/mLDrug
Also called Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension
5.0 mg/mL intralesional injection
Triamcinolone Acetonide 7.5 mg/mLDrug
Also called Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension
7.5 mg/mL intralesional injection
Triamcinolone Acetonide 10 mg/mLDrug
Also called Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension
10 mg/mL intralesional injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks. Receives: Drug: Placebos |
| Triamcinolone Acetonide 2.5 mg/mL | Experimental | Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. Receives: Drug: Triamcinolone Acetonide 2.5 mg/mL |
| Triamcinolone Acetonide 5.0 mg/mL | Experimental | Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. Receives: Drug: Triamcinolone Acetonide 5.0 mg/mL |
| Triamcinolone Acetonide 7.5 mg/mL | Experimental | Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. Receives: Drug: Triamcinolone Acetonide 7.5 mg/mL |
| Triamcinolone Acetonide 10 mg/mL | Experimental | Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. Receives: Drug: Triamcinolone Acetonide 10 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
The most effective concentration of intralesional triamcinolone acetonide will be determined between 0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10.0 mg/mL.
Measured: 24 weeks (end of study)
Secondary outcomes (3)
Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
The Nail Psoriasis Severity Index (NAPSI) is used to evaluate nail psoriasis. Scores range from 0 to 8 with 0 indicating no nail psoriasis and higher scores indicating worsening nail psoriasis.
Measured: Baseline, 24 weeks (end of study)
Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)
The NPQ10 comprises 10 questions gauging the impact of nail psoriasis on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, reflecting the proportion of questions answered by the patient. The obtained score correlates proportionally with the level of functional difficulty experienced, with 0% indicating no impairment and 100% indicating the worst possible impairment.
Measured: Baseline, 24 weeks (end of study)
Number of Participants With at Least One Adverse Event
Adverse events will only include those that are determined to be related to the study drug.
Measured: 24 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start11 Mar 2020
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Lipner, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991936
- Sponsor's protocol ID
- 1609017586
- Status last verified
- Feb 2024
- First submitted
- 18 Jun 2019
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
- ClinicalTrials.gov ID
- NCT03991936
- Acronym / sponsor ID
- 1609017586
- Conditions
- Nail Psoriasis, Nail Diseases
- Keywords
- Nail Psoriasis, Nail Diseases, Triamcinolone acetonide, Triamcinolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlacebosParticipants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks. |
| Triamcinolone Acetonide 2.5 mg/mL | Experimental | Drug: Triamcinolone Acetonide 2.5 mg/mLParticipants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. |
| Triamcinolone Acetonide 5.0 mg/mL | Experimental | Drug: Triamcinolone Acetonide 5.0 mg/mLParticipants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. |
| Triamcinolone Acetonide 7.5 mg/mL | Experimental | Drug: Triamcinolone Acetonide 7.5 mg/mLParticipants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. |
| Triamcinolone Acetonide 10 mg/mL | Experimental | Drug: Triamcinolone Acetonide 10 mg/mLParticipants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Diagnosed with nail psoriasis in at least 2 fingernails
- Willing to give written informed consent and able to adhere to procedures and visit schedules
- Must consent to having the fingernails photographed during the study period
Key exclusion criteria (6 listed)
- Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study. This is including, but not limited to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, allergy to triamcinolone acetonide, local anesthetic, normal saline, or any other material used for procedures
- Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 month within the 6 months of study (exception: inhaled steroids)
- Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study
- Subject who is unwilling to abstain from any cosmetic nail treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail treatments, no nail polish use, no other topical prescription nail medication)
- Subject who is unwilling to abstain from any medical nail treatments on their nails other than the study intervention (i.e. topical steroids, anti-fungal creams) for the duration of the study intervention and for duration of the washout period (if applicable)
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 |
|---|---|---|
| PlacebosAlso: Saline solution for injectionNormal saline intralesional injection | Drug | Placebo |
| Triamcinolone Acetonide 2.5 mg/mLAlso: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension2.5 mg/mL intralesional injection | Drug | Triamcinolone Acetonide 2.5 mg/mL |
| Triamcinolone Acetonide 5.0 mg/mLAlso: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension5.0 mg/mL intralesional injection | Drug | Triamcinolone Acetonide 5.0 mg/mL |
| Triamcinolone Acetonide 7.5 mg/mLAlso: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension7.5 mg/mL intralesional injection | Drug | Triamcinolone Acetonide 7.5 mg/mL |
| Triamcinolone Acetonide 10 mg/mLAlso: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension10 mg/mL intralesional injection | Drug | Triamcinolone Acetonide 10 mg/mL |
Primary outcome
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
Time frame: 24 weeks (end of study)
The most effective concentration of intralesional triamcinolone acetonide will be determined between 0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10.0 mg/mL.
3 secondary outcomes
Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline, 24 weeks (end of study)
Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)
Time frame: Baseline, 24 weeks (end of study)
Number of Participants With at Least One Adverse Event
Time frame: 24 weeks (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shari Lipner, MD, PhD principal investigator
Weill Medical College of Cornell University
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 Triamcinolone Acetonide 2.5 mg/mL, Triamcinolone Acetonide 5.0 mg/mL and Triamcinolone Acetonide 7.5 mg/mL in people with Nail Psoriasis and Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 6 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 27 Mar 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis (time frame: 24 weeks (end of study)). 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 27 Mar 2024.