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.: PACTR201808213089174 Date of Approval: 02/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fractionated microneedle radiofrequency versus botuinum toxin A in primary axillary hyperhidrosis
Official scientific title Efficacy and safety of fractionated microneedle radiofrequency versus botuinum toxin A in primary axillary hyperhidrosis: A randomized controlled clinical trial.
Brief summary describing the background and objectives of the trial Primary axillary hyperhidrosis (PAH) is a chronic idiopathic disorder of excessive sweating that affects the axillae. Treatment options include topical application of aluminum chloride, administration of anticholinergic agents and beta-blockers, tap water iontophoresis, botulinum toxin A (BTX-A) injection, excision and suction curettage of sweat glands, or transthoracic endoscopic sympathectomy. Radiofrequency (RF) has recently emerged as a new therapeutic modality in PAH. This study aims at comparing the efficacy and safety of fractionated microneedle radiofrequency with Botulinum toxin A injection in primary axillary hyperhidrosis.
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: Devices
Anticipated trial start date 01/08/2018
Actual trial start date
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group fractionated microneedle radiofrequency 1 session every 3 weeks 4 sessions Radiofrequency (RF) has recently emerged as a new therapeutic modality in primary axillary hyperhidrosis . RF energy is conducted electrically to tissue and provides tissue heating, depending on the specific tissue resistance. The combination of RF and fractional microneedle technology creates an effective method with a better safety profile for treating various dermatological ailments. 20
Control Group Botulinum toxin A 50 IU single dose Botulinum toxin A has been proven to be an effective modality in treatment of primary axillary hyperhidrosis in several studies In hyperhidrosis, botulinum toxin type A acts by blocking the release of acetylcholine from overactive cholinergic sudomotor nerve fibres. These innervate eccrine sweat glands, so excessive sweating is reduced. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients older than 18 years. 2. Patients with bilateral PAH grade 3 and 4 hyoerhidrosis disease severity score (HDSS) 1. History of surgery for PAH. 2. History of botulinum toxin therapy within the previous 6 months. 3. History of pacemaker implantation or any other electronic implants. 4. Active infection in the treatment area. 5. Tendency for keloid formation. 6. Pregnancy or breastfeeding. 7. Neuromuscular disease e.g. myasthenia gravis. 8. Known hypersensitivity from Botulinum toxin. 9. Autoimmune disease. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 07/07/2018 Research ethics committee of kasr al aini
Ethics Committee Address
Street address City Postal code Country
Nafezet sheem el shafeey st, kasr al ainy cairo 00202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparative clinical effectiveness at 1, 2, 3 and 6 months, in the form of reduction of sweating in the treated site 6 months
Secondary Outcome 1. Comparative safety of both interventions during the procedure, short-term (0-6 months) and long-term (6-12 months). 2. Long-term comparative clinical effectiveness (6-12 months) 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology department Kasr Al Ainy hospitals 27 Nafezet sheem el Shafaey, Kasr el Ainy street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Reem Osama Eid hadara street, nerko 3rd settlement cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Reem Osama reemosama1989@gmail.com 00201003577387 hadara street, maadi
City Postal code Country Position/Affiliation
cairo Egypt Demonstartor of Dermatology cairo university
Role Name Email Phone Street address
Scientific Enquiries Vanessa Hafez vanessahafez@hotmail.com 00201001688434 mohandeseen
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of dermatology cairo university
Role Name Email Phone Street address
Principal Investigator Iman Shaarawy ahmed.elbadri@yahoo.com 00201007172888 sheikh zayed
City Postal code Country Position/Affiliation
giza Egypt Professor of dermatology cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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