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

NCT02181790 | Terminated Phase 4 Results

• 2 other identifiers: GCO 14-0580PD14-01323
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis, Skin or Nails

Keywords

psoriasis; palmoplantar; acitretin; retinoids; laser treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  baseline and week 8

Study Arms (2)

First Group

EXPERIMENTAL

excimer laser treatment to one palm and/or one sole

Device: Excimer laser; Drug: Acitretin

Second Group

EXPERIMENTAL

excimer laser treatment to both palms and/or soles

Device: Excimer laser; Drug: Acitretin

Interventions

Excimer laser DEVICE

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

Also known as: laser treatment

First Group; Second Group

Acitretin DRUG

17.5mg/d

Also known as: Soriatane

First Group; Second Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Lasers, Excimer; Laser Therapy; Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Dr Mark Lebwohl
• Organization: Icahn School of Medicine at Mount Sinai

giselle.singer@mssm.edu

2122413288

Study Officials

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair Dermatology

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 10, 2021
• Results First Posted: May 2, 2017

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)