Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000581066
Ethics application status
Approved
Date submitted
14/07/2010
Date registered
20/07/2010
Date last updated
20/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultraviolet and Light Amplification by Stimulated Emission of Radiation (LASER) in vitiligo
Scientific title
A randomised controlled trial of Light Amplification by Stimulated Emission of Radiation (LASER) application and ultraviolet application on decreasing the area affected by vitiligo.
Secondary ID [1] 252209 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
women and men with vitiligo 257739 0
Condition category
Condition code
Inflammatory and Immune System 257913 257913 0 0
Autoimmune diseases
Skin 257925 257925 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It was selected 22 subjects with vitiligo. Both are interventions groups. They were divided in 2 groups: A and B. the group A (n=11) was submited by LASER applications and the group B by ultraviolet. the LASER was Heluim Neon (HeNE), density 6j/cm2, pontual tecnique 1 minute and 15 s per point. The total points and session is area dependent. It was about 15 minutes. The LASER was applied transcutaneously and realized 2 sessions per week, totalizing 10 sessions. The patients were reevaluated after 10 sessions.
Intervention code [1] 256803 0
Treatment: Devices
Comparator / control treatment
The ultraviolet was narrow band B therapy. It was applied twice a week, during 5 week, totalizing 10 sessions. The dose of ultraviolet was determined by Saidman test. the duration of session was about 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 258774 0
measure of area that lost pigment. It was utilized a photograph machine to take a picture of the area and the autocad programm is used to measure the area
Timepoint [1] 258774 0
first session and tenth session
Secondary outcome [1] 264834 0
nil
Timepoint [1] 264834 0
nil

Eligibility
Key inclusion criteria
vitiligo disease
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
other dermatology diseases
exposed by sun frequently
under medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 2761 0
Brazil
State/province [1] 2761 0

Funding & Sponsors
Funding source category [1] 257282 0
University
Name [1] 257282 0
unibrasil
Country [1] 257282 0
Brazil
Primary sponsor type
Individual
Name
Ana Carolina Brandt de Macedo
Address
Aristides pereira da cruz street, 1. complement 57. Portao. CEP: 80330290. Curitiba, Parana
Country
Brazil
Secondary sponsor category [1] 256527 0
University
Name [1] 256527 0
unibrasil
Address [1] 256527 0
Rua Konrad Adenauer, 442. Taruma. CEP: 82821-020. Curitiba, Parana
Country [1] 256527 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259307 0
unibrasil ethics comitee
Ethics committee address [1] 259307 0
Rua Konrad Adenauer, 442. Taruma. CEP: 82821-020. Curitiba, Parana
Ethics committee country [1] 259307 0
Brazil
Date submitted for ethics approval [1] 259307 0
Approval date [1] 259307 0
Ethics approval number [1] 259307 0

Summary
Brief summary
The purpose of the study was evaluated the application of ultraviolet and LASER in patients with vitiligo. It was selected 22 subjects with vitiligo. Both are interventions groups. They were divided in 2 groups: A and B. the group A (n=11) was submitted by LASER applications and the group B by ultraviolet. the LASER was Heluim Neon (HeNE), density 6j/cm2, pontual tecnique 1minutes and 15 s per point. The total points and session is area dependent. It was about 15 minutes. The LASER was applied transcutaneously and realized 2 sessions per week, totalizing 10 sessions. The patients were reevaluated after 10 sessions. The ultraviolet was narrow band B therapy. It was applied twice a week, during 5 week, totalizing 10 sessions. The dose of ultraviolet was determined by Saidman test. The duration of session was about 5 minutes. The area of despigmentation was measure in the corel drawn computer program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31391 0
Address 31391 0
Country 31391 0
Phone 31391 0
Fax 31391 0
Email 31391 0
Contact person for public queries
Name 14638 0
ana carolina brandt de macedo
Address 14638 0
aristide pereira da cruz street, 1 complement 57. portao, curitiba, parana. CEP: 80330-390
Country 14638 0
Brazil
Phone 14638 0
+55 41 33297058
Fax 14638 0
Email 14638 0
[email protected]
Contact person for scientific queries
Name 5566 0
ana carolina brandt de macedo
Address 5566 0
aristide pereira da cruz street, 1 complement 57. portao, curitiba, parana. CEP: 80330-390
Country 5566 0
Brazil
Phone 5566 0
+55 41 33297058
Fax 5566 0
Email 5566 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.