Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles

NCT ID: NCT02181790

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

Brief 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 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.

Conditions

Psoriasis, Skin or Nails

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First Group

excimer laser treatment to one palm and/or one sole

Group Type: EXPERIMENTAL

Excimer laser

Intervention Type: DEVICE

twice weekly treatments with the excimer laser for a total of 8 weeks.

Acitretin

Intervention Type: DRUG

17.5mg/d

Second Group

excimer laser treatment to both palms and/or soles

Group Type: EXPERIMENTAL

Excimer laser

Intervention Type: DEVICE

twice weekly treatments with the excimer laser for a total of 8 weeks.

Acitretin

Intervention Type: DRUG

17.5mg/d

Interventions

Excimer laser

twice weekly treatments with the excimer laser for a total of 8 weeks.

Intervention Type: DEVICE

Acitretin

17.5mg/d

Intervention Type: DRUG

Other Intervention Names

laser treatment; Soriatane

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• History of photosensitive disorders
• Ingestion of drugs reported to cause photosensitivity reactions
• Presence of erythroderma or generalized pustular psoriasis
• Concomitant use of sunlamps

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Mark Lebwohl

Professor & Chair Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Lebwohl, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

PD14-01323

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 14-0580

Identifier Type: -

Identifier Source: org_study_id