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.: PACTR202508850407266 Date of Registration: 04/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative split face study for the efficacy and safety of micro-needling alone versus micro-needling combined with botulinum toxin-A or autologous stem cells or irradiated amniotic collagen matrix in the treatment of atrophic acne scars
Official scientific title Comparative split face study for the efficacy and safety of micro-needling alone versus micro-needling combined with botulinum toxin-A or autologous stem cells or irradiated amniotic collagen matrix in the treatment of atrophic acne scars
Brief summary describing the background and objectives of the trial Acne is a persistent chronic skin inflammatory condition of the pilosebaceous follicles that affects people all over the world. Post-acne scars are permanent patient-distressing sequel of acne that doesn't fade with time. It even becomes worse with skin aging. Acne scars usually result from the inflammatory acne lesions and their severity correlates with acne severity, duration, and the delay of management. Atrophic types of acne scars are by far the most common. Different treatment modalities have been under trial for treating them, such as chemical peels, laser-assisted resurfacing, dermabrasion, and micro-needling. However, none of them has proven optimal efficacy and many combinations are still under investigation. This study aims to assess and compare the efficacy and safety of micro-needling alone versus micro-needling combined with BTX-A, or combined with Autologous Cell Micro-graft, or combined with irradiated amniotic collagen matrix in the treatment of Atrophic Post-Acne Scars.
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: Other
Anticipated trial start date 01/01/2024
Actual trial start date 01/06/2024
Anticipated date of last follow up 01/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group botulinum toxin a 3 sessions (one session per month) were done for all patients Group I: - Micro-needling alone on the right side of the face. - Micro-needling combined with botulinum toxin-A on the left side of the face 20 Active-Treatment of Control Group
Experimental Group autologous stem cells 3 sessions (one session per month) were done for all patients Micro-needling alone on the right side of the face. - Micro-needling combined with autologous stem cells on the left side of the face 20
Experimental Group irradiated amniotic collagen 3 sessions (one session per month) were done for all patients Micro-needling alone on the right side of the face. - Micro-needling combined with irradiated amniotic collagen matrix on the left side of the face 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
.1-Patients aged 18-50 years presented with atrophic post-acne scars. 2-Patients who will accept to be included in the study, and will sign a written consent. 3-Patients agreed to participate after full explanation of the procedure 1-Patients who have any hypersensitivity reactions to BTX-A or autologous stem cells or amniotic collagen matrix or any material used in the study. 2-Pregnant and lactating women. .3-Patients with active inflammatory acne or active infection in the treatment area. 4-Patients with premalignant or malignant lesions in the treatment area. 5-Patients with photosensitive dermatoses. 6-Patients with a history of chronic diseases (liver or kidney diseases). 7-Patients with coagulation defects and blood diseases Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 21/11/2023 research ethics faculty of medicine
Ethics Committee Address
Street address City Postal code Country
el bahr street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluation the efficacy and safety of micro-needling alone versus micro-needling combined with BTX-A, or combined with Autologous Cell Micro-graft, or combined with irradiated amniotic collagen matrix in the treatment of Atrophic Post-Acne Scars. 3month post intervention
Secondary Outcome evaluation effect in degree of patient satisfaction 3month post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology and Venereology Department in Tanta University Hospitals el bahr street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
marwa magdy elbaher street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta universty el baher street tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
soha abdulla el baher tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator marwa agiza marwa.agiza89@gmail.com +201553176762 elbaher
City Postal code Country Position/Affiliation
tanta Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries soha hawwam soha_abdullah80@yahoo.com +201091199874 el baher
City Postal code Country Position/Affiliation
tanta Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries marwa magdy marwa.agiza89@gmail.com +20155376762 elbaher
City Postal code Country Position/Affiliation
tanta Egypt doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available All individual participant data collected during trial after deidentification will be shared Data will be with anyone who wishes acess to the data Type of analysis to achieve approved proposal Study Protocol Immediately following publication no end date micro-needling alone versus micro-needling combined with botulinum toxin-A or autologous stem cells or irradiated amniotic collagen matrix in the treatment of atrophic acne scars
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/08/2025 PACTR Admin 01 Jun 2024
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 01/08/2025 Numerical criteria .Patients aged 18-50 years presented with atrophic post-acne scars. • Patients who will accept to be included in the study, and will sign a written consent. • Patients agreed to participate after full explanation of the procedure .1-Patients aged 18-50 years presented with atrophic post-acne scars. 2-Patients who will accept to be included in the study, and will sign a written consent. 3-Patients agreed to participate after full explanation of the procedure
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 01/08/2025 Numerical criteria Patients who have any hypersensitivity reactions to BTX-A or autologous stem cells or amniotic collagen matrix or any material used in the study. .Pregnant and lactating women. .Patients with active inflammatory acne or active infection in the treatment area. Patients with premalignant or malignant lesions in the treatment area. • Patients with photosensitive dermatoses. • Patients with a history of chronic diseases (liver or kidney diseases). • Patients with coagulation defects and blood diseases 1-Patients who have any hypersensitivity reactions to BTX-A or autologous stem cells or amniotic collagen matrix or any material used in the study. 2-Pregnant and lactating women. .3-Patients with active inflammatory acne or active infection in the treatment area. 4-Patients with premalignant or malignant lesions in the treatment area. 5-Patients with photosensitive dermatoses. 6-Patients with a history of chronic diseases (liver or kidney diseases). 7-Patients with coagulation defects and blood diseases
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/08/2025 Age group minimum 18years until maximum age group 50 Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/08/2025 To make time point clear Primary Outcome, evaluation the efficacy and safety of micro-needling alone versus micro-needling combined with BTX-A, or combined with Autologous Cell Micro-graft, or combined with irradiated amniotic collagen matrix in the treatment of Atrophic Post-Acne Scars. , 3month Primary Outcome, evaluation the efficacy and safety of micro-needling alone versus micro-needling combined with BTX-A, or combined with Autologous Cell Micro-graft, or combined with irradiated amniotic collagen matrix in the treatment of Atrophic Post-Acne Scars. , 3month post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/08/2025 Make time point clear Secondary Outcome, evaluation effect in degree of patient satisfaction , 3month Secondary Outcome, evaluation effect in degree of patient satisfaction , 3month post intervention