Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000324718
Ethics application status
Approved
Date submitted
1/09/2021
Date registered
22/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
To compare the efficacy of tap water iontophoresis versus Aluminum Chloride hexahydrate in the treatment of palmar and plantar excessive sweating
Scientific title
To compare the efficacy of tap water iontophoresis versus Aluminum Chloride hexahydrate in the treatment of palmoplantar hyperhidrosis
Secondary ID [1] 305145 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palmoplantar Hyperhidrosis 323406 0
Condition category
Condition code
Skin 320962 320962 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A patients are treated with tape water iontophoresis(TWI). In which electrical current is passed through skin in tape water(10-20 mA). Palms and soles are kept for 10 minutes in tape water iontophoresis device by dermatologist in dermatology department at PNS shifa hospital Karachi, three times a week, for 4 weeks.

Results will be assessed by the hyperhidrosis disease severity index(HDSS), improvement of sweating on a scale of 1 to 4.
Intervention code [1] 321601 0
Treatment: Other
Comparator / control treatment
20% aluminium chloride hexahydrate(AC) liquid solution applied topically at palms and soles(5-10ml) for whole night and washed in the morning. this treatment is given for 4 weeks. Adherence monitoring is done by participant self-report diary and results will be assessed by hyperhidrosis disease severity index(HDSS), improvement of sweating on a scale of 1 to 4.
Control group
Active

Outcomes
Primary outcome [1] 328808 0
Hyperhidrosis severity scale (HDSS)
1. My sweating is never noticeable and never interferes with my daily activities
2. My sweating is tolerable but sometimes interferes with my daily activities
3, My sweating is barely tolerable and frequently interferes with my daily activities
4. My sweating is intolerable and always interferes with my daily activities.
Timepoint [1] 328808 0
Assessed weekly from baseline to 4 weeks after the start of treatment date, with 4 weeks after the start of treatment date being the primary time point.
Secondary outcome [1] 400492 0
Nil
Timepoint [1] 400492 0
Nil

Eligibility
Key inclusion criteria
All hyperhidrosis patients of at least 2 months duration with Hyperhidrosis severity scale (HDSS) of 2,3 or 4 at baseline.
Minimum age
10 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with organic disease, such as hyperthyroidism.
Prior surgical procedure for hyperhidrosis.
Prior botulinum toxin treatment.

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)
coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 24084 0
Pakistan
State/province [1] 24084 0
Karachi

Funding & Sponsors
Funding source category [1] 309536 0
Hospital
Name [1] 309536 0
PNS SHIFA HOSPITAL KARACHI
Country [1] 309536 0
Pakistan
Primary sponsor type
Hospital
Name
PNS SHIFA HOSPITAL KARACHI
Address
PNS SHIFA HOSPITAL Main Korangi Roadd, postal code 07557, Karachi City, Sindh.
Country
Pakistan
Secondary sponsor category [1] 311208 0
None
Name [1] 311208 0
Address [1] 311208 0
Country [1] 311208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309318 0
Ethical committee PNS Shifa hospital Karachi
Ethics committee address [1] 309318 0
PNS Shifa Hospital Main Korangi Road, postal code 07557, Karachi City, Sindh.
Ethics committee country [1] 309318 0
Pakistan
Date submitted for ethics approval [1] 309318 0
05/07/2021
Approval date [1] 309318 0
09/07/2021
Ethics approval number [1] 309318 0
ERC/2021/DERMA/49

Summary
Brief summary
this study is done for determining wether iontophoresis or topical aluminium chloride treatment is good for excessive sweating of palms and soles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113742 0
Dr Muhammad Rahim
Address 113742 0
PNS Shifa Hospital Main Korangi Road, postal code 07557, Karachi City, Sindh.
Country 113742 0
Pakistan
Phone 113742 0
+923128192901
Fax 113742 0
Email 113742 0
[email protected]
Contact person for public queries
Name 113743 0
Muhammad Rahim
Address 113743 0
PNS Shifa Hospital Main Korangi Road, postal code 07557, Karachi City, Sindh.
Country 113743 0
Pakistan
Phone 113743 0
+923128192901
Fax 113743 0
Email 113743 0
[email protected]
Contact person for scientific queries
Name 113744 0
Muhammad Rahim
Address 113744 0
PNS Shifa Hospital Main Korangi Road, postal code 07557, Karachi City, Sindh.
Country 113744 0
Pakistan
Phone 113744 0
+923128192901
Fax 113744 0
Email 113744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participation data collected during the trial after de-identification.
When will data be available (start and end dates)?
Immediately following publication, No End date,
Available to whom?
Anyone who wishes to access the data
Available for what types of analyses?
For any Purpose
How or where can data be obtained?
[email protected]


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.