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Trial record 18 of 31 for:    ACITRETIN

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

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ClinicalTrials.gov Identifier: NCT02181790
Recruitment Status : Terminated (Lack of subjects)
First Posted : July 4, 2014
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Lebwohl, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis, Skin or Nails
Interventions Device: Excimer laser
Drug: Acitretin
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Excimer Laser (One Palm/Sole) Excimer Laser (Both Palms/Soles)
Hide Arm/Group Description

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 treatment to both palms and/or soles

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

Period Title: Overall Study
Started 2 0
Completed 0 0
Not Completed 2 0
Reason Not Completed
study terminated             2             0
Arm/Group Title First Group Second Group Total
Hide Arm/Group Description

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 treatment to both palms and/or soles

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

Total of all reporting groups
Overall Number of Baseline Participants 2 0 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
<=18 years
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
2
 100.0%
0
2
 100.0%
>=65 years
0
   0.0%
0
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
Female
1
  50.0%
0
1
  50.0%
Male
1
  50.0%
0
1
  50.0%
1.Primary Outcome
Title Psoriasis Area and Severity Index (PASI)
Hide Description 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.
Time Frame baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
study terminated before study completion, no data collected
Arm/Group Title First Group Second Group
Hide Arm/Group Description:

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 treatment to both palms and/or soles

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in Dermatology Life Quality Index (DLQI) at Week 8 From Baseline
Hide Description reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study
Time Frame baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
study terminated before study completion, no data collected
Arm/Group Title Excimer Laser (One Palm/Sole) Excimer Laser (Both Palms/Soles)
Hide Arm/Group Description:

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 treatment to both palms and/or soles

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title First Group Second Group
Hide Arm/Group Description

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 treatment to both palms and/or soles

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

All-Cause Mortality
First Group Second Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
First Group Second Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
First Group Second Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Mark Lebwohl
Organization: Icahn School of Medicine at Mount Sinai
Phone: 2122413288
EMail: giselle.singer@mssm.edu
Layout table for additonal information
Responsible Party: Mark Lebwohl, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02181790     History of Changes
Other Study ID Numbers: GCO 14-0580
PD14-01323
First Submitted: July 2, 2014
First Posted: July 4, 2014
Results First Submitted: March 21, 2016
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017