Psoriasis, Skin or NailsPhase 4NCT02181790
Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles
A Phase 4 study testing Excimer laser and Acitretin in people with Psoriasis, Skin or Nails, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be sufficient for treatment of some patients, psoriasis of the palms and soles is particularly challenging to treat, and may not respond to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Skin or Nails
- What is being tested?
- Excimer laser and Acitretin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- 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
- Male or female subject at least 18 years of age
- Diagnosis of psoriasis, with palmoplantar involvement
- Initiated on oral acitretin for treatment of their psoriasis by their physician
Who cannot join
- Subjects less than 18 years old
- Subjects with any skin disease, disease state, or physical condition that would impair evaluation of the skin
- Additional systemic therapy for psoriasis in last 4 weeks
- Additional topical or photo-therapy in last 2 weeks
- Usage of any additional therapy except for emollients and keratolytic agents (5% salicylic acid ointment or 30% urea cream)
- Pre-existent or current cutaneous malignancy affecting the palms and/or soles
Show all 10Show fewer
- History of photosensitive disorders
- Ingestion of drugs reported to cause photosensitivity reactions
- Presence of erythroderma or generalized pustular psoriasis
- Concomitant use of sunlamps
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Addition of 308-nm Excimer Laser to Acitretin Therapy in the Management of Palmoplantar Psoriasis
Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be sufficient for treatment of some patients, psoriasis of the palms and soles is particularly challenging to treat, and may not respond to acitretin alone.
In this study, the focus is on patients who have psoriasis of the palms and soles, and are currently taking acitretin. The aim is to initially recruit 10 patients and offer them treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin tablet. If the side treated with the excimer laser shows greater improvement compared to the other side, the second part of the study will be conducted.
In this second part, another 15 patients will be included. These patients will receive twice weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8 weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin will lead to greater improvement of psoriasis on palms and soles.
Read the detailed description
This open label study evaluated whether a reduction in acitretin dose from 25 mg/day to 17.5 mg/day in patients with severe plaque-type psoriasis undergoing phototherapy treatment improved tolerability while maintaining comparable efficacy.
At baseline, subjects were switched from 25 to 17.5 mg acitretin daily and followed for 12 weeks.
Efficacy evaluations were performed through week 12. The psoriasis area-and severity index (termed PASI) combines assessments of the extent of body-surface involvement in four anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 (no psoriasis) to 72 (severe disease). The physician's global assessment rates the patient's psoriasis overall relative to baseline as 1 (clear), 2 (excellent), 3 (good), 4 (fair), 5 (poor), or 6 (worse) and considers involvement of body surface area (BSA), induration, scaling, and erythema. The 10-item Dermatology Life Quality Index questionnaire, completed by the subject, measures whether psoriasis has an effect on the subject's quality of life, with scores ranging from 0 ("no effect") to 30 ("extremely large effect"). The 15-item Psoriasis Disability Index (PDI), completed by the subject, measures the level of impairment psoriasis has on quality of life, with scores ranging from 0 ("no effect") to 45 ("extremely impaired"). Subjects also completed a subjective assessment of efficacy of the reduced dose of acitretin at week 12 of the study by answering the question "How was your psoriasis over the last 3 months?", with answers ranging from better than before, the same as before, or worse than before.
The safety and tolerability was assessed for the reduced acitretin dose by monitoring adverse events and routine laboratory values through week 12. Serum samples collected at baseline and week 12 were tested for LFTs, lipids, CBC, and chemistry panel. Subjects also completed a subjective assessment of tolerability of the lower dose at week 12 of the study by answering the question, "Did your symptoms from the medicine you noted above improve over the last 3 months?", with answers ranging from better than before, the same as before, or worse than before.
- Conditions
- Psoriasis, Skin or Nails
- Being tested
- Excimer laser, Acitretin
- Keywords
- psoriasis, palmoplantar, acitretin, retinoids, laser treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer laserDevice
Also called laser treatment
twice weekly treatments with the excimer laser for a total of 8 weeks.
AcitretinDrug
Also called Soriatane
17.5mg/d
| Study group | Role | What they receive |
|---|---|---|
| First Group | Experimental | excimer laser treatment to one palm and/or one sole Receives: Device: Excimer laser; Drug: Acitretin |
| Second Group | Experimental | excimer laser treatment to both palms and/or soles Receives: Device: Excimer laser; Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) from baseline after 16 treatments with the excimer laser in the first phase of the study.
Measured: baseline and week 12
Change in Dermatology Life Quality Index (DLQI) at Week 8 From Baseline
reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study
Measured: baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Lack of subjects
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 Psoriasis, Skin or NailsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Lebwohl, Icahn School of Medicine at Mount Sinai
- Investigators
- Mark Lebwohl, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181790
- Sponsor's protocol ID
- GCO 14-0580
- Other IDs
- PD14-01323
- Status last verified
- Feb 2021
- First submitted
- 2 Jul 2014
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of 308-nm Excimer Laser to Acitretin Therapy in the Management of Palmoplantar Psoriasis
- ClinicalTrials.gov ID
- NCT02181790
- Acronym / sponsor ID
- GCO 14-0580
- Conditions
- Psoriasis, Skin or Nails
- Keywords
- psoriasis, palmoplantar, acitretin, retinoids, laser treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be sufficient for treatment of some patients, psoriasis of the palms and soles is particularly challenging to treat, and may not respond to acitretin alone.
In this study, the focus is on patients who have psoriasis of the palms and soles, and are currently taking acitretin. The aim is to initially recruit 10 patients and offer them treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin tablet. If the side treated with the excimer laser shows greater improvement compared to the other side, the second part of the study will be conducted.
In this second part, another 15 patients will be included. These patients will receive twice weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8 weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin will lead to greater improvement of psoriasis on palms and soles.
Detailed description
This open label study evaluated whether a reduction in acitretin dose from 25 mg/day to 17.5 mg/day in patients with severe plaque-type psoriasis undergoing phototherapy treatment improved tolerability while maintaining comparable efficacy.
At baseline, subjects were switched from 25 to 17.5 mg acitretin daily and followed for 12 weeks.
Efficacy evaluations were performed through week 12. The psoriasis area-and severity index (termed PASI) combines assessments of the extent of body-surface involvement in four anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 (no psoriasis) to 72 (severe disease). The physician's global assessment rates the patient's psoriasis overall relative to baseline as 1 (clear), 2 (excellent), 3 (good), 4 (fair), 5 (poor), or 6 (worse) and considers involvement of body surface area (BSA), induration, scaling, and erythema. The 10-item Dermatology Life Quality Index questionnaire, completed by the subject, measures whether psoriasis has an effect on the subject's quality of life, with scores ranging from 0 ("no effect") to 30 ("extremely large effect"). The 15-item Psoriasis Disability Index (PDI), completed by the subject, measures the level of impairment psoriasis has on quality of life, with scores ranging from 0 ("no effect") to 45 ("extremely impaired"). Subjects also completed a subjective assessment of efficacy of the reduced dose of acitretin at week 12 of the study by answering the question "How was your psoriasis over the last 3 months?", with answers ranging from better than before, the same as before, or worse than before.
The safety and tolerability was assessed for the reduced acitretin dose by monitoring adverse events and routine laboratory values through week 12. Serum samples collected at baseline and week 12 were tested for LFTs, lipids, CBC, and chemistry panel. Subjects also completed a subjective assessment of tolerability of the lower dose at week 12 of the study by answering the question, "Did your symptoms from the medicine you noted above improve over the last 3 months?", with answers ranging from better than before, the same as before, or worse than before.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Group | Experimental | Device: Excimer laser, Drug: Acitretinexcimer laser treatment to one palm and/or one sole |
| Second Group | Experimental | Device: Excimer laser, Drug: Acitretinexcimer laser treatment to both palms and/or soles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subject at least 18 years of age
- Diagnosis of psoriasis, with palmoplantar involvement
- Initiated on oral acitretin for treatment of their psoriasis by their physician
Key exclusion criteria (10 listed)
- Subjects less than 18 years old
- Subjects with any skin disease, disease state, or physical condition that would impair evaluation of the skin
- Additional systemic therapy for psoriasis in last 4 weeks
- Additional topical or photo-therapy in last 2 weeks
- Usage of any additional therapy except for emollients and keratolytic agents (5% salicylic acid ointment or 30% urea cream)
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 |
|---|---|---|
| Excimer laserAlso: laser treatmenttwice weekly treatments with the excimer laser for a total of 8 weeks. | Device | First Group, Second Group |
| AcitretinAlso: Soriatane17.5mg/d | Drug | First Group, Second Group |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: baseline and week 12
The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) from baseline after 16 treatments with the excimer laser in the first phase of the study.
Change in Dermatology Life Quality Index (DLQI) at Week 8 From Baseline
Time frame: baseline and week 8
reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mark Lebwohl, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Excimer laser and Acitretin in people with Psoriasis, Skin or Nails, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Mar 2021. 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. 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 2 May 2017). 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?
Psoriasis Area and Severity Index (PASI) (time frame: baseline and week 12). The study lists 2 primary outcomes in all. 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 Mar 2021.