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.: PACTR201812717126560 Date of Approval: 21/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between subcision followed by 35% TCA versus subcision followed by microneedling in the treatment of acne scars: a prospective comparative study.
Official scientific title Comparison between subcision followed by 35% TCA versus subcision followed by microneedling in the treatment of acne scars: a prospective comparative study.
Brief summary describing the background and objectives of the trial Background: Acne scars treatment is difficult and challenging because of the variety in the acne scars morphology and the limited ability of the available treatment options to improve the scars. Multiple treatment modalities are used and each has its unique place in the treatment plan. Subcision is a non operative procedure that aims to break the fibrous strands that tether the scar to the underlying subcutaneous tissue, in which a needle is inserted through a puncture in the skin surface and passed in multiple directions to create a pocket under the scar to release the fibrous attachments.Microneedling, which is also known as percutaneous collagen induction therapy or needle dermabrasion, is a skin resurfacing procedure which involves the use of fine needles that create micro skin wounds. Trichloroacetic acid (TCA) causes protein denaturation named keratocoagulation resulting in white frost. 35% is used for medium depth peeling. Objective: To compare the efficacy and safety of both combined subcision and microneedling versus combined subcision and peeling in the treatment of acne scars.
Type of trial CCT
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: Other
Anticipated trial start date 01/05/2018
Actual trial start date
Anticipated date of last follow up 28/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Subcision followed by 6 sessions of 35 percent TCA peel on half of the face Subcision is done first to release all the scars followed by 6 sessions of TCA peel, one month apart on the cheeks area 6 sessions , one month apart for 6 months Subcision is done using a 2.4 mm keratome knife to release the fibrotic strands of acne scars within the skin, followed by 6 sessions of medium depth peel using 35 percent Trichloro acetic acid, passed on the cheeks until frosting is seen then washed thoroughly by water. Sessions are one month apart. 20 Active-Treatment of Control Group
Experimental Group Subcision followed by 6 sessions of microneedling on half of the face Sbcision of all acne scars is done followed by 6 sessions of microneedling ,one month apart. for 6 months duration Subcision is done followed by 6 sessions of microneedling using Dermapen (12 needles) at 2mm depth. Passage in three opposite directions on the skin, where the target is pinpoint bleeding. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients older than 18 years 2- Bilateral Rolling and Boxcar acne scars 1- Retinoid treatment within the last 6 months 2-Pregnant & lactating females 3- Bleeding tendency 4- Active inflammatory acne 5- Lidocaine sensitivity 6- Tendency of Keloid formation 7- Laser treatment within the last 6 months. 8-Post inflammatory hyper pigmentation 9- Skin types V & VI. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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 25/09/2018 Research Ethical Committee at Dermatology departments Cairo University Hospital Egypt
Ethics Committee Address
Street address City Postal code Country
1 Al-Saraya Street, Manial cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Find the most efficient therapy for rolling and box scars. 6 months
Secondary Outcome See whether the rolling scars or the boxcars would respond better to the different modes of therapy. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr AlAiny hospital 1 Al-Saraya Street, Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sarah Orabi 1 Al-Saraya street, Manial, Cairo Cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dermatology department Kasr ElEiny Hospital Dermatology department Cairo 00202 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marwa El Mesidy 1 Al-Saraya street, Manial, Cairo Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Zayed zayed.amira@gmail.com 00201002581689 1 Al-Saraya Street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Professor of Dermatology Cairo university
Role Name Email Phone Street address
Public Enquiries Sarah Orabi sarahorabi@gmail.com 00201114202054 1 Al-Saraya Street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Dermatology resident Cairo University hospital
Role Name Email Phone Street address
Scientific Enquiries Sarah Orabi sarahorabi@gmail.com 00201114202054 1 Al-Saraya Street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Dermatology resident Cairo University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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