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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505474708118 Date of Registration: 21/05/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Autologous Cultured Fibroblast Cell Therapy for Treatment of Stria Alba
Official scientific title Autologous Cultured Fibroblast Cell Therapy for Treatment of Stria Alba
Brief summary describing the background and objectives of the trial : To evaluate the efficacy and safety of autologous cultured fibroblast for improvement of stria alba. There is growing evidence showing that human autologous cultured fibroblast transplantation is a safe alternative treatment to prevent and reduce the structural changes in aging skin. Previous data indicates that injections of autologous fibroblasts increase collagen formation, accompanied by a concomitant increase in thickness and density of dermal collagen. Our study will highlight the technique of autologous cultured fibroblast and it is indication for treatment of stria alba and this wasn't done before.
Type of trial Non-Randomised
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 01/05/2021
Actual trial start date 01/05/2021
Anticipated date of last follow up 01/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
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
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Autologous cultured fibroblast injection 3 doses Follow up for 6 months The present study included 15 patients a with stria alba. The study was approved by the Research Ethical Committee, Faculty of Medicine, Ain Shams University and fulfilled all the ethical aspects required in human research. All patients received full information about description of the procedure of treatment, possible side effects, photo documentation and they all provided written consent. the patients were injected intradermally by autologous fibroblast suspension at 2 weeks intervals with total of 3 sessions. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients 20 to 45 years old. No sex predilection. Patients clinically diagnosed having stria alba. Pregnant & lactating females. Patients complaining of striae rubra. Patients with a history of current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect & any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex & recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 45 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 30/04/2021 Research ethics committee ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical assessment and clinical scoring, histopathological examination, antera photo images. For objective assessment of width of strisa, transparent papers were used to copy the width of SA and Adobe Photoshop CS6 image analysis software was used to measure the width at baseline before injection, at 3rd month after injection and 6th month after injectio At 3 and 6 months post intervention
Secondary Outcome Clinical Evaluation of treatment outcome by calculating the percentage of reduction in the width of SA, the results were rated by one of the investigators (AA) as 0%‐ 25% = poor response, 26%‐ 50% = fair response, 51%‐ 75% = good response, and 76%‐ 100% = excellent response were done at baseline (before injection) and at 3rd month after injection: At 3 and 6 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university Abbassia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Norhan khaled Mokattam Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Norhan Khaled Mokattam Cairo Egypt Self sponser
COLLABORATORS
Name Street address City Postal code Country
Ghada fathy Shorouk Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Norhan Khaled norhankhaledderma@gmail.com 01099978172 Mokattam
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of dermatology and venereology Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Ghada Fathy ghadamom@yahoo.com 01006422675 Shorouk
City Postal code Country Position/Affiliation
Cairo Egypt Professor of dermatology and venereology ain shams university
Role Name Email Phone Street address
Public Enquiries Hanan Saleh dr.hanansaleh@hotmail.com 01227293813 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Professor of dermetology and venereology ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data will be available including dictionaries. Individual participant data that underlie the results reported in this article. after deidenti fication (text, tables, figures, and appendices. Immediately following publica-tion. No end date. Data will be available with Anyone who wishes to access for any purpose. I will upload the data and send it to your email after publishing. Study Protocol Just after publishing Fibroblast culture…stria alba
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 13/03/2025 PACTR Admin 01 May 2021
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation to intervention 29/04/2025 PACTR Admin Randomised Non-randomised
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 18/03/2025 Entering each criteria in new line egnant and lactating females. Patients complaining of striae rubra. Patients with a history of or current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect or any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex or recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study. egnant and lactating females. Patients complaining of striae rubra. Patients with a history of or current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect or any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex or recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 09/04/2025 Spelling mistake egnant and lactating females. Patients complaining of striae rubra. Patients with a history of or current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect or any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex or recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study. Pregnant and lactating females. Patients complaining of striae rubra. Patients with a history of or current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect or any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex or recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 17/05/2025 You had comment Pregnant and lactating females. Patients complaining of striae rubra. Patients with a history of or current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect or any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex or recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study. Pregnant & lactating females. Patients complaining of striae rubra. Patients with a history of current malignancy. Patients with delayed wound healing. Patients on systemic steroids in the last 6 months. Patients with bleeding tendency,coagulation defect & any systemic disease. Patients with recurrent skin infections e.g recurrent herpes simplex & recurrent micro abscesses. Patients treated for stria alba with any procedure within 6 months prior to the study.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 31/03/2025 To tick all included age group Adult: 19 Year-44 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 18/03/2025 You asked for clarification Primary Outcome, Clinical assessment and clinical scoring, histopathological examination, antera photo images. For objective assessment of width of strisa, transparent papers were used to copy the width of SA and Adobe Photoshop CS6 image analysis software was used to measure the width at baseline before injection, at 3rd month after injection and 6th month after injectio, At 3 and 6 months Primary Outcome, Clinical assessment and clinical scoring, histopathological examination, antera photo images. For objective assessment of width of strisa, transparent papers were used to copy the width of SA and Adobe Photoshop CS6 image analysis software was used to measure the width at baseline before injection, at 3rd month after injection and 6th month after injectio, At 3 and 6 months post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/03/2025 You asked for clarification Secondary Outcome, Clinical Evaluation of treatment outcome by calculating the percentage of reduction in the width of SA, the results were rated by one of the investigators (AA) as 0%‐ 25% = poor response, 26%‐ 50% = fair response, 51%‐ 75% = good response, and 76%‐ 100% = excellent response were done at baseline (before injection) and at 3rd month after injection: , At 3 and 6 months Secondary Outcome, Clinical Evaluation of treatment outcome by calculating the percentage of reduction in the width of SA, the results were rated by one of the investigators (AA) as 0%‐ 25% = poor response, 26%‐ 50% = fair response, 51%‐ 75% = good response, and 76%‐ 100% = excellent response were done at baseline (before injection) and at 3rd month after injection: , At 3 and 6 months post intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/03/2025 The mail was incorrect TRUE, Research ethics committee ain shams university, Abbassia, Cairo, 202, Egypt, , 30 Apr 2021, 20226857539, alaazorkany5@gmail.com, 33512_30640_4737.pdf TRUE, Research ethics committee ain shams university, Abbassia, Cairo, 202, Egypt, , 30 Apr 2021, 20226857539, REC-FMASU@med.asu.edu.eg, 33512_30640_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 19/03/2025 I wasn’t understanding IPD Before autologous fibroblast injection (baseline), the width of stria ranged from 4-17.4 mm (mean 8.18 ± 3.85), after treatment at 3rd month, stria width ranged from 2.9 – 14.8 (mean 7.17 ± 3.26) and at the 6th month ranged from 2.9 – 14.8 (mean 7.16 ± 3.27).Comparison of width of stria before versus after injection showed non significant difference (p value 0.062).On contrast, the histopathological examination by H&E, Masson Trichome and Orcein stain a showed significant improvement in the form of increased epidermal thickness, better collagen arrangement and thickness and increased elastic fibers contents. Through mail norhankhaledderma@gmail.com
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/04/2025 Wasn’t understanding Through mail norhankhaledderma@gmail.com All individual participant data collected during the trial after deidentification
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/04/2025 Wasn’t understanding All individual participant data collected during the trial after deidentification All individual participant data collected during the trial after deidentification .
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 13/04/2025 You asked for summarized results All individual participant data collected during the trial after deidentification . All individual participant data collected during the trial after deidentification . Results: Before autologous fibroblast injection (baseline), the width of stria ranged from 4-17.4 mm (mean 8.18 ± 3.85), after treatment at 3rd month, stria width ranged from 2.9 – 14.8 (mean 7.17 ± 3.26) and at the 6th month ranged from 2.9 – 14.8 (mean 7.16 ± 3.27).Comparison of width of stria before versus after injection showed non significant difference (p value 0.062).On contrast, the histopathological examination by H&E, Masson Trichome and Orcein stain a showed significant improvement in the form of increased epidermal thickness, better collagen arrangement and thickness and increased elastic fibers contents.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 17/05/2025 Wasnot understanding . All individual participant data collected during the trial after deidentification . Results: Before autologous fibroblast injection (baseline), the width of stria ranged from 4-17.4 mm (mean 8.18 ± 3.85), after treatment at 3rd month, stria width ranged from 2.9 – 14.8 (mean 7.17 ± 3.26) and at the 6th month ranged from 2.9 – 14.8 (mean 7.16 ± 3.27).Comparison of width of stria before versus after injection showed non significant difference (p value 0.062).On contrast, the histopathological examination by H&E, Masson Trichome and Orcein stain a showed significant improvement in the form of increased epidermal thickness, better collagen arrangement and thickness and increased elastic fibers contents. Individual participants data will be available including dictionaries. Individual participant data that underlie the results reported in this article. after deidenti fication (text, tables, figures, and appendices. Immediately following publica-tion. No end date. Data will be available with Anyone who wishes to access for any purpose. I will upload the data and send it to your email after publishing.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 19/03/2025 I wasn’t understanding IPD By the end of the year After publishing
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 17/05/2025 Wasnot understanding . After publishing Just after publishing
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 13/04/2025 No change here Fibroblast culture…stria alba Fibroblast culture…stria alba
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 17/04/2025 You asked for demographic data and i sent too the first step outline in results about the width of stria https://iscanner.com/sharing/472be8b9
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 17/05/2025 . https://iscanner.com/sharing/472be8b9