Trial Outcomes & Findings for Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles (NCT NCT02181790)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

baseline and week 12

Results posted on

2021-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Excimer Laser (One Palm/Sole) excimer laser treatment to one palm and/or one sole Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks.	Excimer Laser (Both Palms/Soles) excimer laser treatment to both palms and/or soles Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks.
Overall Study STARTED	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Excimer Laser (One Palm/Sole) excimer laser treatment to one palm and/or one sole Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks.	Excimer Laser (Both Palms/Soles) excimer laser treatment to both palms and/or soles Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks.
Overall Study study terminated	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Group n=2 Participants excimer laser treatment to one palm and/or one sole Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks.	Second Group excimer laser treatment to both palms and/or soles Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and week 12

Population: study terminated before study completion, no data collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline and week 8

Population: study terminated before study completion, no data collected

reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study

Outcome measures

Outcome data not reported

Adverse Events

First Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Second Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mark Lebwohl

Icahn School of Medicine at Mount Sinai

Phone: 2122413288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place