Protocol summary

Summary
l Few reports about nevus spilus treatment using intense pulsed light have been published. The aim of current study was to evaluate efficacy and safety of nevus spilus treatment with an intense pulsed light device (Palomar Max-G Intense Pulsed Light). Patients with diagnosed nevus spilusconfirmed via histopathology, will be treated by an intense pulsed light source using parameters according to the skin type and location of lesions in one to three consecutive treatment sessions at 14-21 day intervals for three month. Two months after finishing the treatment, the effect will be evaluated base on close-up photographs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052414285N2
Registration date: 2014-07-09, 1393/04/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-09, 1393/04/18
Registrant information
Name
Zahra Hosseininezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
normohamad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-06-01, 1392/03/11
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intense Pulsed Light in Treatment of Nevus Spilus in in patients attending dermatology clinic of razi hospital
Public title
Intense Pulsed Llight in treatment of Nevus Spilus in patients attending dermatology clinic of razi hospital
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : nevus Spilus confirmed via histopathology Exclusion Criteria : pregnancy; lactation; tanning, scar formation history; previous treatment with laser
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Quods Ave, Keshavarz Bulvard, Tehran, IRAN
City
Tehran
Postal code
14174
Approval date
2013-05-12, 1392/02/22
Ethics committee reference number
92/د/130/230

Health conditions studied

1

Description of health condition studied
Nevus Spilus
ICD-10 code
D22, D22.3
ICD-10 code description
Melanocytic naevi

Primary outcomes

1

Description
Decrease in Color Density
Timepoint
one months
Method of measurement
Photography Comapring

Secondary outcomes

1

Description
Ulceration
Timepoint
Beggining of the study, First Month, Second Month, Third Month, at the end of the study
Method of measurement
Clinical Exam

2

Description
Hypopigmentation
Timepoint
Beggining of the study, First Month, Second Month, Third Month, at the end of the study
Method of measurement
Clinical Exam

3

Description
Scar formation
Timepoint
Beggining of the study, First Month, Second Month, Third Month, at the end of the study
Method of measurement
Clinical Exam

Intervention groups

1

Description
Included patients will be treated by Intense pulsed light system with these parameters: pulse width 10-30ms, Fluence 44-50 jouls. treatment will be conducted for three consecutive sessions one month time window between them, after every session photography of lesions will be done.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Shirin Gojehlou
Street address
1199663911, Razi Ave, Vahdate eslami Ave, Hafiz Street, Tehran IRAN
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi Hopsital, Tehran University of Medical Sciences
Full name of responsible person
Mis. Gojehlou
Street address
Tehran, Razi Hopsital
City
Tehran
Grant name
مرکز تحقیقات بیماریهای تاولی بیمارستان رازی
Grant code / Reference number
11121
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Hopsital, Tehran University of Medical Sciences
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
Razi Hospital
Full name of responsible person
Amir Hooshang Ehsani
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Ave, Vahdate eslami Ave, Hafiz Street, Tehran , IRAN
City
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Fax
+98 21 5561 8989
Email
ehsanih@sina.tums.ac.ir
Web page address
www.tums.ac.ir/razi

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi Hospital
Full name of responsible person
Amir Hooshang Ehsani
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Ave, Vahdate eslami Ave, Hafiz Street, Tehran , IRAN
City
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Fax
+98 21 5561 8989
Email
ehsanih@sina.tums.ac.ir
Web page address
www.tums.ac.ir/razi

Person responsible for updating data

Contact
Name of organization / entity
Razi Hospital
Full name of responsible person
Amir Hooshang Ehsani
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Ave, Vahdate eslami Ave, Hafiz Street, Tehran , IRAN
City
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Fax
+98 21 5561 8989
Email
ehsanih@sina.tums.ac.ir
Web page address
tums.ac.ir/razi

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
Loading...