To investigate the efficacy of Pulsed Dye Laser with or without topical sirolimus for treatment of port wine stain.
Design
A concealed, randomized, double blind inter_patient placebo controlled clinical trial(phase 3) with a parallel group design of 15 patients.Block randomization has been done.
Settings and conduct
15 patient will treat in razi hospital with PDL (in whole of lesion)
every 8 weeks up to 6month(4 sessions) with using sirolimus 0.2% in one part and the placebo on another part every night after laser therapy.
Serum sirulimus level at the end of 2th and 6th months will be evaluate.
Phothography before first PDL and 2month after last treatment will be done.
Side effects of the procedure were also recorded at each session.
Participants/Inclusion and exclusion criteria
1 to 50 years old patient; no contrandiation for sirulimos; no treatment for port wine stain during previous 6 months
Intervention groups
using pdl laser with sirulimos or placebo in every part of lesion
Main outcome variables
reducing in erythem of lesion
General information
Reason for update
Acronym
PWS :Port Wine Stain
IRCT registration information
IRCT registration number:IRCT20170617034590N2
Registration date:2018-09-07, 1397/06/16
Registration timing:retrospective
Last update:2018-09-07, 1397/06/16
Update count:0
Registration date
2018-09-07, 1397/06/16
Registrant information
Name
Zahra Hallaji
Name of organization / entity
Razi Skin hospital
Country
Iran (Islamic Republic of)
Phone
+98 55618989
Email address
halajiza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Vice-chancellor for Research of Tehran University of Medical Sciences 2- Behestan Darou (P.J.S)
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2017-12-01, 1396/09/10
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of PDL laser with or without topical sirolimus 0.2% for treatment of portwine stain
Public title
Effect of Pulsed Dye Laser and topical sirolimus for treatment of port wine stain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1 to 50 years old patient with portwine stain
Not received any treatments during the last 6 months
Exclusion criteria:
Being pregnant, actively trying to become pregnant or breast-feeding
previous history of malignancy
Having hypersensitivity or contraindication to the treatments
Age
From 1 year old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
In every patient ,lesion will be divided to equal part and use placebo in one part and sirulimos in another.
Actual sample size reached:
15
More than 1 sample in each individual
Actual sample size in each individual:
2
In every patient ,lesion will be divided to equal part and use placebo in one part and sirulimos in another.
Randomization (investigator's opinion)
Randomized
Randomization description
With block randomization we use sirolimus and placebo in upper or lower parts of lesion
Blinding (investigator's opinion)
Double blinded
Blinding description
patients used labaled_cream (up and down) .
dermatologist who did laser and analyzing the pictures having no data about placebo or treatment site.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg, Poursina st.
City
Tehran
Province
Tehran
Postal code
1416634391
Approval date
2017-09-05, 1396/06/14
Ethics committee reference number
ir.tums.medicine.rec.1396.3368
Health conditions studied
1
Description of health condition studied
port-wine stain
ICD-10 code
Q82.5
ICD-10 code description
Congenital non-neoplastic naevus
Primary outcomes
1
Description
reducing erythem in lesion
Timepoint
2months after last treatment
Method of measurement
photographs taken on months 0 and 2 months after last treatment and analyze with visioface device( to determine of reducing erythma in quantity )
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
At the end of the study
Method of measurement
Patient Global Assesment (asking them to score 0 _10)
Intervention groups
1
Description
Intervention/control 1: PDL on months 0, 2, 4 and 6 in whole of lesion(control and treatment site)
Category
Treatment - Other
2
Description
Intervention 2 :using sirulimos in one part of lesion
Category
Treatment - Drugs
3
Description
Control group: using cream of placebo in one part of lesion
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Hamid-Reza Mahmoudi
Street address
Razi Skin Hospital, Razi Ave., Vahdate eslami Ave., Hafiz St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Email
hr_mahmoody@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahin Akhound Zadeh
Street address
Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg., Poursina st.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Fax
+98 21 5563 0174
Email
hr_mahmoody@yahoo.com
Web page address
htpps://www.behestandarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research of Tehran University of Medical Sciences