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.: PACTR202004808998657 Date of Approval: 21/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fractional carbon dioxide laser versus fractional Microneedle Radiofrequency in the Treatment of Post Burn Scars: a comparative randomized split scar study
Official scientific title Fractional carbon dioxide laser versus fractional Microneedle Radiofrequency in the Treatment of Post Burn Scars: a comparative randomized split scar study
Brief summary describing the background and objectives of the trial Fractional Co2 laser resurfacing produces columns of thermal damage at specific depths (Manstein and Herron, 2004). The thermal effect stimulates a therapeutic wound healing response with heat – shock proteins, myofibroblasts, and an increased collagen III production, and therapy raises a potential for texture remodeling so that the appearance of burn scar will be improved (Luabach and tannous, 2006). Fractional microneedle radiofrequency (FMR) devices deliver energy to the deep dermis through insulated microneedles without destroying the epidermis (Kim et al., 2014). Fractional thermal injury of deep dermal collagen induced a vigorous wound healing process leading to dermal remodeling and the generation of new collagen and elastin (Alexiades-Armenakas et al., 2008). TGFβ1 stimulates growth and collagen secretion and is thought to be intergral to keloid formation (Peltonenet et al., 1991). It induces an increase in fibronectin bio synthesis, a link glycoprotein that binds to integrins and other matrix molecules, forming an early component of granulation tissue more rapidly in keloid fibroblasts, suggesting modification of this regulatory pathway (Ashcroft et al., 1999). Our current study aims at assessing the efficacy of fractional CO2 laser compared to fractional microneedle radiofrequency in the treatment of post burn scars, and the implications of both treatment modalities on TGFβ1 level. By this study, we hope to pave the way for optimum treatment strategies for patients with this disfiguring condition.
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 01/06/2019
Actual trial start date
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Experimental Group Fractional microneedle radiofrequency Four treatment sessions 6 weeks apart 24 weeks In each patient, a large lesion will be outlined and divided into two parts 2-3 cm apart so that one will be randomly assigned to fractional Co2 laser and the other one will receive fractional microneedle radiofrequency. If the lesion size is small two symmetrical lesions will be picked. The parameters of fractional microneedle radiofrequency; 7-8 v, Exposure time: 800 ms. Depth: 3 - 3.5 mm (using non-insulated needles), Frequency: 2 Hz. Topical anasthesia will be applied beforehand All patents will receive 4 treatment sessions 6 weeks apart. Assessment will be done via : a- Clinical evaluation: Clinical assessment will be done by calculating patient and observer scar assessment scale before every session and one month after the last session. b- Photographic documentation: before every session and one month after least session. c- Histopathological and biochemical evaluation.: Pretreatment biopsy: • One 3mm a punch biopsy will be taken per lesions to be treated prior to treatment sessions. Post treatment biopsy : • One 3mm punch biopsy will be taken per lesion one month after the last session. • Biopsies will be fixed in 10%natural buffered formalin, and then embedded in paraffin blocks. Sections will be prepared for routine staining by H & E • Sections will be graded as regards the appearance and pattern of dermal collagen and elastin before and one month after the last session • Ten sections will be prepared for histochemical staining of collagen fibers using masson trichrome stain and elastic fibers using orcein stain and will be evaluated by an image analyzer. • Biochemical evaluation: The tissue level of TGFβ1will be measured by ELISA in biopsies obtained from the scar area: o Before the treatment sessions o One month after the last session 20
Control Group Fractional carbon dioxide laser four treatment sessions 6 weeks apart . 24 weeks • In each patient, a large lesion will be outlined and divided into two parts 2-3 cm apart so that one will be randomly assigned to fractional Co2 laser and the other one will receive fractional microneedle radiofrequency. If the lesion size was small two symmetrical lesions were picked. Topical anasthesia will be applied beforehand • The parameters of fractional Co2 laser that will be used in the treatment 20 watt, 800-1000 μs dwell time, according to height 2 to 3 stacks, 500 μm spacing • All patents will receive four treatment sessions 6 weeks apart . Assessment will be done via : a- Clinical evaluation: Clinical assessment will be done by calculating patient and observer scar assessment scale before every session and one month after the last session. b- Photographic documentation: before every session and one month after least session. c- Histopathological and biochemical evaluation.: Pretreatment biopsy: • One 3mm a punch biopsy will be taken per lesions to be treated prior to treatment sessions. Post treatment biopsy : • One 3mm punch biopsy will be taken per lesion one month after the last session. • Biopsies will be fixed in 10%natural buffered formalin, and then embedded in paraffin blocks. Sections will be prepared for routine staining by H & E • Sections will be graded as regards the appearance and pattern of dermal collagen and elastin before and one month after the last session • Ten sections will be prepared for histochemical staining of collagen fibers using masson trichrome stain and elastic fibers using orcein stain and will be evaluated by an image analyzer. • Biochemical evaluation: The tissue level of TGFβ1will be measured by ELISA in biopsies obtained from the scar area: o Before the treatment sessions o One month after the last session 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients with post burn hypertrophic scars more than one year. • Participants should be more than 16 years old. • Both males and females • Patents with two separate lesions, each of them about 2 to 3 cm OR a single large sized lesion equal to or more than 10 cm. • Patients with unrealistic expectations. • Patients with active skin, infections e.g herpes or autoimmune disease. • Non compliant patient. • Patients who had received any form of treatment during the last eight weeks prior to treatment (such as intralesional steroid injection) or a laser procedure during the last six months. • Recent use of isotretinoin within six months prior to the procedures. • Patient with known allergy to lidocaine. • Pregnancy, Lactation. • Patients with previous history of adverse outcome related to laser. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 17 Year(s) 80 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 Dermatology Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- To assess the improvement in the selected treated burn scars by fractional Co2laser and fractional microneedle radiofrequency. 2- To assess the improvement in the density and arrangement of collagen fibers and elastic fibershistopathologically. 3- To assess the tissue level of TGFβ1before and after both treatment modalities. 28 weeks
Secondary Outcome To compare the fractional Co2laser versus fractional microneedle radiofrequency in the treatment of post burn scars clinically, histopathologically and biochemically. 28 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasr AlAiny Kasr AlAiny 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 Faculty of Medicine Cairo University Kasr AlAiny Kasr AlAiny street Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma El Zahraa Shawky Hamouda Ali Kasr AlAiny street Cairo 11562 Egypt
Aya Magdi Alorbani Kasr AlAiny street Cairo 11562 Egypt
Shereen Osama Mohamed Tawfic Kasr AlAiny street Cairo 11562 Egypt
Akmal Saad Sayed Kasr AlAiny street Cairo 11562 Egypt
Olfat Gamil Shaker Kasr AlAiny street Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shereen Tawfic shereemosamat@yahoo.com +201220085050 Kasr Alainy street
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Professor of Dermatology Cairo University Faculty of Medicine
Role Name Email Phone Street address
Principal Investigator Akmal Saad akmsaad@yahoo.com +201001648953 kasr alainy street
City Postal code Country Position/Affiliation
cairo 11562 Egypt Professor of dermatology Cairo university Faculty of medicine Kasr Alainy
Role Name Email Phone Street address
Scientific Enquiries Aya AlOrbani ayamagdi87@hotmail.com +201149554577 kasr alainy street
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Lecturer of Dermatology Cairo university faculty of medicine kasrvalainy
Role Name Email Phone Street address
Public Enquiries Fatma El Zahraa Hamouda drfatmashawky80@gmail.com +201028450742 kasr alainy street
City Postal code Country Position/Affiliation
cairo 11562 Egypt Specialist of dermatology in Gharb Aswan Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification ( text , tables, figures, appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of data has been approved by an independent review committee identified for this purpose. For individual participant data meta analysis
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