Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006915898923 Date of Approval: 22/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Treatment of primary palmar hyperhidrosis
Official scientific title Efficacy, safety and quality of life of oxybutynin versus aluminum chloride hexahydrate in treating primary palmar hyperhidrosis
Brief summary describing the background and objectives of the trial Palmar hyperhidrosis is characterized by excessive sweating beyond the physiological needs of the patient's body and the most frequent form is primary or essential. Different treatments protocols have been proposed to control or decrease sweating. This study aimed to compare the efficacy and safety of oral oxybutynin versus topical aluminum chloride hexahydrate (ACH) in treating primary palmar hyperhidrosis. Also, to assess quality of life (QOL) as a measure of improvement in hyperhidrosis state.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/05/2020
Actual trial start date 25/05/2016
Anticipated date of last follow up 15/11/2020
Actual Last follow-up date 15/11/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
16.04.71 IRB faculty of medicine Mansoura university
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group topical aluminum chloride hexahydrate 20% solution 12 weeks Topical ACH (20% solution) and the solution was prepared by a single pharmacist working in the hospital pharmacy. According to Miller, the solution will be applied to a completely dry palm skin at night, (when sweating is diminished). ACH applications stays on the skin 6 to 8 hours before being washed off and will be repeated every 24 to 48 hours until anhidrosis is attained. Occlusion with gloves or plastic film enhances penetration of the drug. Application will be repeated for three to five consecutive nights, then one to two times a week as needed to control sweating. Treated skin is washed at the following morning. 40 Active-Treatment of Control Group
Experimental Group Oral Oxybutynin 5 mg tab and syrup 5mg/5ml 12 weeks Oral Oxybutynin (5 mg tab and syrup 5mg/5ml) will be used for 12 weeks according to the standardized protocol of Wolosker and his colleges. Treatment will be started at 2•5 mg per day and increased gradually until it reaches an effective dose, without exceeding 10 mg per day. Patients weighing ≥ 40 kg will receive 2.5 mg of oxybutynin (once daily in the evening) for 7 days, then the dose will be increased to 2.5 mg twice daily from day 7–21 and then to 5 mg twice daily from day 22 to the end of week 12. Patients weighing <40 kg will receive the same treatment regimen for the first 3 weeks, but the dose will not be increased after day 21. When there is severe side effects (especially dry mouth), the final dose will be decreased by 2.5 mg. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study include patients with primary palmar hyperhidrosis aged nine years or more with Hyperhidrosis Disease Severity Scale (HDSS) of at least 2 and agree to keep on follow-up. Pregnant and lactating women, hypersensitive to any of the active ingredients or have a history of hypersensitivity, known closed angle glaucoma or known prostatic disorders, intestinal obstruction, toxic megacolon, intestinal atony, severe ulcerative colitis, and myasthenia. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 9 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/05/2016 IRB Faculty of medicine Mansoura university
Ethics Committee Address
Street address City Postal code Country
Algomhoria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HDSS 12 weeks
Secondary Outcome Clinical grading 12 weeks
Secondary Outcome QOL 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology department faculty of medicine Mansoura university Algomhoria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Heba Shawky Attallah Elsayed Albostan street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university faculty of medicine Algomhoria street Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Heba Shawky Attallah Elsayed Albostan street Mansoura 35516 Egypt
Elshahat Farag Ahmed Sharaf Algomhoria street Mansoura 35516 Egypt
AbdelHady ElGilany Algomhoria street Mansoura 35516 Egypt
Youssef EL Bayoumy Youssef Algomhoria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elshahat Farag shahatfarag@hotmail.com 00201001966194 Algomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt professor of dermatology faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries AbdelHady ElGilany ahgilany@gmail.com 00201060714481 Algomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt professor of public health and community medicine Faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohame Abdelshaheed becheerful@hotmail.com 00201002874175 36 Albostan street, Talkha
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of plastic surgery mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic data (age, sex, occupation) outcomes (HDSS, clinical grading, QOL) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 1 year data can be accessed from the corresponding author upon request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information