Protocol summary

Summary
The aim of this study was to compare the efficacy of monthly triamcinolone iontophoresis and daily topical daivobet in the treatment of nail psoriasis. This study was a clinical trial (bilateral comparison study) conducted on 16 patients with nail psoriasis referred to the Faghihi dermatology clinics from March 2014 to March 2015. Patients with mild to moderate psoriasis with the age range of 6-70 were entered our study after dermatologist clinical diagnosis confirmation. Exclusion criteria were iontophoresis contraindications and patient's dissatisfaction. In this study we want compare the effect of tiamcinolone ionthophoresis on nail psoriasis with bed and matrix invulvment wih topical daivobet.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050233778N1
Registration date: 2017-06-26, 1396/04/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Shahla Hoseinpoor
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 97132125239
Email address
hoseinpor@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Univercity of Medical Sciences
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Triamcinolone Iontophoresis versus topical Daivobet in the treatment of nail psoriasis.
Public title
Tiramcinolone for teratment of nail psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of older than 6 years; Age less than 70 years; Lack of sensitivity to the medication. Exclusion criteria:Pacemakers; Pregnancy; Metal Orthopedic Implants; Cardiac Arrhythmia; Patient dissatisfaction .
Age
From 6 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Medicine, Shiraz Univercity of Medical Sciences
Street address
School of Medicine, Shiraz, Fars, Iran
City
Shiraz
Postal code
Approval date
2017-05-28, 1396/03/07
Ethics committee reference number
IR.SUMS.MED.REC.1396.37

Health conditions studied

1

Description of health condition studied
Nail psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis Vulgaris

Primary outcomes

1

Description
Nail pitting,onycholysis,subungual hyperkeratosis
Timepoint
monthly
Method of measurement
NAPSI SCORE, photography

Secondary outcomes

1

Description
Pain, burning,drug reaction
Timepoint
Monthly
Method of measurement
Questionaaire

Intervention groups

1

Description
For one hand monthly triamcilone ionthophoresis with concentration 4mg/ml was done.
Category
Treatment - Drugs

2

Description
For one hand daily application of daivobet included 50 microgram/gr calcipoteriole +500 microgram/gr bethamethasine was applied.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahhid Faghihi hospital
Full name of responsible person
Shahla Hoseinpor
Street address
Shahid Faghihi Hospital, Shiraz, Fars
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deramtology Molecholar Center, Shiraz University of Medical Scienes
Full name of responsible person
Sara Ranjbar
Street address
Dermatology Molecholar Cententer, Shahid Faghihi Hospital, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deramtology Molecholar Center, Shiraz University of Medical Scienes
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahla Hoseinpoor
Position
Dermatology Residence
Other areas of specialty/work
Street address
Dermatology Clinic, Shahid Faghihi Hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3212 5239
Fax
Email
hoseinpor@sums.ac.irshahla_hoseinpoor@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Saki
Position
Assistant Professor
Other areas of specialty/work
Street address
Dermatology Clinic, Shahid Faghihi Hospital , Shiraz
City
Shiraz
Postal code
Phone
+98 712125239
Fax
Email
nasrins85@yahoo.comshahla_hoseinpoor@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahla Hoseinpoor
Position
Dermatology Residence
Other areas of specialty/work
Street address
Dermatology Clinic, Shahid Faghihi Hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3212 5239
Fax
Email
hoseinpor@sums.ac.irshahla_hoseinpoor@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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