Nail PsoriasisPhase 2LAsEDNCT04580537
Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails
A Phase 2 study testing Enstilar and Ablative fractional laser in people with Nail Psoriasis, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Enstilar and Ablative fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Oct 2020to 1 Jun 2021
- 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
- Informed consent obtained before any trial-related activities.
- At least 18 years of age (inclusive)
- Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits
- Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails)
Who cannot join
- Insufficient knowledge of written and spoken Danish.
- Pregnant and lactating women and women who intend to become pregnant during the trial
- Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers
- Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment
- Any non-psoriatic disease activity within test areas
- Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated.
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- Known predisposition for hypertrophic scar formation.
- Known allergy to any of the components of Enstilar®.
- Current treatment with systemically or locally acting medications which might counter or influence the trial aim
- Received any drug as part of a research trial within 30 days prior to initial trial dosing.
- Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels.
- Ongoing fungal infections of psoriatic nails
- Close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor
- In the opinion of the investigator, the participant is unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails - a Proof-of-concept, Single-center, Prospective, Open-label, Randomized, Clinical Trial With an Intra-individual Comparison of Treatments
The trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). It is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of Enstilar® in treating nail psoriasis.
- Conditions
- Nail Psoriasis
- Being tested
- Enstilar, Ablative fractional laser
- Keywords
- Nail disease, Psoriasis, Laser-assisted drug delivery, Enstilar
- Medical subject headings
- Nail Diseases, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnstilarDrug
Also called Cutaneous foam
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
Ablative fractional laserDevice
Also called AFL
Pre-treatment of affected fingers (nail plates, nail folds)
| Study group | Role | What they receive |
|---|---|---|
| Laser-assisted Enstilar delivery | Experimental | Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) Receives: Drug: Enstilar; Device: Ablative fractional laser |
| Enstilar | Active comparator | Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) Receives: Drug: Enstilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
Change from baseline to end of treatment in N-NAIL score per nail for each treatment
Measured: Day1 : Week 24
Secondary outcomes (1)
Safety profile and local tissue response to laser treatment and Enstilar® application
Number of laser- and Enstilar®- emergent adverse events per subject; change in local tissue response score from baseline to Week 12 and Week 24.
Measured: Day 1 : Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start2 Oct 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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.
- 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
- Model description
- a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Innovation Lab
- Responsible party
- Principal investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD PhD DMSc, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580537
- Sponsor's protocol ID
- LAsED
- Other IDs
- 2019-002960-29, H-19047222, 2019
- Acronym
- LAsED
- Status last verified
- Mar 2022
- First submitted
- 2 Oct 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails - a Proof-of-concept, Single-center, Prospective, Open-label, Randomized, Clinical Trial With an Intra-individual Comparison of Treatments
- ClinicalTrials.gov ID
- NCT04580537
- Acronym / sponsor ID
- LAsED / LAsED
- Conditions
- Nail Psoriasis
- Keywords
- Nail disease, Psoriasis, Laser-assisted drug delivery, Enstilar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- LEO Innovation Lab
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- 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 trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). It is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of Enstilar® in treating nail psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
| Arm | Type | Receives |
|---|---|---|
| Laser-assisted Enstilar delivery | Experimental | Drug: Enstilar, Device: Ablative fractional laserAblative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) |
| Enstilar | Active comparator | Drug: EnstilarDaily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any trial-related activities.
- At least 18 years of age (inclusive)
- Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits
- Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails)
Key exclusion criteria (14 listed)
- Insufficient knowledge of written and spoken Danish.
- Pregnant and lactating women and women who intend to become pregnant during the trial
- Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers
- Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment
- Any non-psoriatic disease activity within test areas
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 |
|---|---|---|
| EnstilarAlso: Cutaneous foamDaily application on affected fingers (nail plates, nail folds, and surrounding skin) | Drug | Enstilar, Laser-assisted Enstilar delivery |
| Ablative fractional laserAlso: AFLPre-treatment of affected fingers (nail plates, nail folds) | Device | Laser-assisted Enstilar delivery |
Primary outcome
Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
Time frame: Day1 : Week 24
Change from baseline to end of treatment in N-NAIL score per nail for each treatment
1 secondary outcome
Safety profile and local tissue response to laser treatment and Enstilar® application
Time frame: Day 1 : Week 24
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 2 Mar 2022.
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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.
Merete Haedersdal, MD PhD DMSc principal investigator
Bispebjerg Hospital
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 Enstilar and Ablative fractional laser in people with Nail Psoriasis, run by Bispebjerg Hospital at 1 site in Denmark.
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 14 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 2 Mar 2022. 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 Denmark. 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?
Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis (time frame: Day1 : Week 24). 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 2 Mar 2022.