Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000626066
Ethics application status
Approved
Date submitted
28/07/2010
Date registered
30/07/2010
Date last updated
30/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Successful Treatment Of Auricular Acupuncture On Flat Warts
Scientific title
The Successful Treatment Of Auricular Acupuncture On Flat Warts
Secondary ID [1] 252338 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
flat warts(verruca plana) 257839 0
Condition category
Condition code
Skin 258005 258005 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
weekly auricular acupuncture for 10 weeks on the ear vein located at the back of the ear, each weekly session lasts for about 1 hour
Intervention code [1] 256899 0
Treatment: Other
Comparator / control treatment
0.1 % of tretinoin ointment topically every night for 10 weeks
Control group
Active

Outcomes
Primary outcome [1] 258866 0
The outcome was measured by clinical observation.The recovery rate of the treatment group was better than that of the control group (p < 0.05) and there was a significant difference in the total effective rate between the control group and the auricular acupuncture treatment group after surgery (46.66 % and 96.67 %, respectively, p < 0.01)
Timepoint [1] 258866 0
measured at baseline, and then ten weeks after treatment
Secondary outcome [1] 264991 0
The outcome was measured by clinical observation.During the treatment period, no adverse effects were observed by the investigators or reported by patients.
Timepoint [1] 264991 0
measured at baseline, and then ten weeks after treatment

Eligibility
Key inclusion criteria
patients aged 8 to 50 years; patients who met the clinical diagnostic criteria of flat warts; capability of providing written informed consent; and willingness and ability to comply with all procedures of the trial and attend all scheduled contacts at the investigational site.
Minimum age
8 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of concomitant diseases which included severe allergic disease, blood disease, acute or chronic contagious disease, abnormalities in the endocrine system and scar constitution; patients having accepted other relevant therapies that might influence the results of the present study; eruption of skin lesion recently with such concomitant symptoms as severe pruritus, deepening colour or the surrounding flushes of the skin lesion; patients who dropped out halfway.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2792 0
China
State/province [1] 2792 0

Funding & Sponsors
Funding source category [1] 257356 0
Government body
Name [1] 257356 0
research program from the Health Bureau of Shanghai
Country [1] 257356 0
China
Primary sponsor type
Individual
Name
Suli Ning
Address
No.8, Caobao Rd,Shanghai,P.R.China
Country
China
Secondary sponsor category [1] 256596 0
None
Name [1] 256596 0
Address [1] 256596 0
Country [1] 256596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259376 0
Shanghai Eighth People?s Hospital
Ethics committee address [1] 259376 0
Ethics committee country [1] 259376 0
China
Date submitted for ethics approval [1] 259376 0
Approval date [1] 259376 0
Ethics approval number [1] 259376 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31446 0
Address 31446 0
Country 31446 0
Phone 31446 0
Fax 31446 0
Email 31446 0
Contact person for public queries
Name 14693 0
Yan Li
Address 14693 0
No. 826, Zhangheng Rd,Shanghai, P.R.China
Country 14693 0
China
Phone 14693 0
86-21-51980057
Fax 14693 0
Email 14693 0
[email protected]
Contact person for scientific queries
Name 5621 0
Yan Li
Address 5621 0
No. 826, Zhangheng Rd,Shanghai, P.R.China
Country 5621 0
China
Phone 5621 0
86-21-51980057
Fax 5621 0
Email 5621 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.