Evaluation of the additional effects of two different methods needling (far needling and near needling) for treatment of vitiligo with PUVA and comparison far and near needling together
Design
This clinical trial with control group and parallel unblind randomised group had done on 8 patient with vitiligo
Settings and conduct
This study is a Clinical Trial. The study populations are patients refereed to dermatology clinic of ]mam Reza Hospital of Mashhad University of medical sciences. 8 patients with 88 patches of leukoderma in upper limb selected.For 16 patches PUVA (group 1) and for 36 patches PUVA+NEAR NEEDLING(group 2) and for 36 patches PUVA+FAR NEEDLING(group 3) for 3 months(PUVA 3 times weekly and NEEDLING every other week) were done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 12 years, resistance to conventional treatments, indications for PUVA therapy, presence of at least 4 depigmented patches,in both right and left sides of the body,not having a new lesion in the recent 6 months, having consented to participate in the study.
exclusion criteria:hemorrhagic disorders,contraindication for PUVA, patients with positive Koebner phenomenon.
Intervention groups
Control group:PUVA alone
Intervension group 1:PUVA+NEAR NEEDLING
Intervension group 2:PUVA+FAR NEEDLING
Main outcome variables
Lesion pigmentation change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140211016554N3
Registration date:2019-02-26, 1397/12/07
Registration timing:retrospective
Last update:2019-02-26, 1397/12/07
Update count:0
Registration date
2019-02-26, 1397/12/07
Registrant information
Name
Vahid Mashayekhi-Goyonlo
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2490
Email address
mashayekhiv@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
2013-09-23, 1392/07/01
Actual recruitment end date
2014-09-23, 1393/07/01
Trial completion date
2014-12-14, 1393/09/23
Scientific title
Evaluation of the additional effects of two different methods needling (far needling and near needling) for treatment of vitiligo with PUVA
Public title
Evaluation of the additional effects of two different methods needling (far needling and near needling) for treatment of vitiligo with PUVA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 12 years
Resistance to conventional treatments and indications for PUVA therapy
Presence of at least 4 depigmented patches,in both right and left sides of the body
Not having a new lesion in the recent 6 months
Having consented to participate in the study
Exclusion criteria:
Hemorrhagic disorders
Contraindication for PUVA
Patients with positive Koebner phenomenon
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Actual sample size reached:
8
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple randomisation had done by computer in order to use random numbers categories
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
IR.MUMS.REC.1392.96
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Lesion pigmentation change
Timepoint
After 3 months
Method of measurement
Phototherapy
Secondary outcomes
empty
Intervention groups
1
Description
Control group: PUVA alone.PUVA was done three times a weak for three months
Category
Treatment - Other
2
Description
Intervention group: PUVA+NEAR NEEDLING.Needling was performed every other weak for three months.In this method a 30 gage needle was entered gently from the pigmented lesion margin to the center
Category
Treatment - Surgery
3
Description
Intervention group: PUVA+FAR NEEDLING.In this method a needle was inserted and moved through the hair follicular crater then the needle was expelled and gently inserted in the leukodermal zone