Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580691
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars a Split-face
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars a Split-face
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Both male and female patients with atrophic acne scars
All patients underwent one session of subcision before receiving
A cog PDO threads on one side of the face one session B plasma gel on the other side one session Primary outcomes clinical improvements reported by physicians Secondary out come satisfaction levels of patients
All patients underwent one session of subcision before receiving
A cog PDO threads on one side of the face one session B plasma gel on the other side one session Primary outcomes clinical improvements reported by physicians Secondary out come satisfaction levels of patients
Detailed Description:
The treatment area was prepared by anesthetizing the acne-scarred region with a 2 lidocaine injection mixed with 11000 adrenaline administered at each entry point after sterilizing the area with povidone-iodine solution Subcision was performed using an 18-G cannula needle inserted parallel to the skin surface The skin was stretched while the needle was maneuvered along the scar margins on both sides of the face creating a tunnel and releasing the scars from their bases The procedures endpoint was marked by a partial to complete loss of resistance in the treated area
After subcision patients underwent the following treatments
Plasma Gel Therapy One half of the face was assigned to the plasma gel therapy group Plasma gel was prepared in two steps
Platelet Poor Plasma PPP Preparation Ten milliliters of venous blood were drawn from each patient and collected in sterile anticoagulant-equipped vacuum tubes The blood was centrifuged at 72 g for 15 minutes at room temperature then the plasma layer was centrifuged again for 5 minutes at 1006 g to yield 65 ml of PPP and 05 ml of platelet-rich plasma PRP
Gel Formation The PPP syringes were placed in a hot water bath 60-100C for 1 minute then in a cold bath 8-0C for 1 minute to turn the plasma into a viscous gel The gel was injected into the scarred areas immediately after subcision
Thread Treatment The other side of the face received PDO thread treatment Cog PDO threads were inserted using a blunt-tipped cannula in a Z pattern within the scarred areas filling the pockets created by subcision
Randomization Subcision was performed on both sides of the face followed by either plasma gel injection or thread insertion Patients were randomly assigned to either modality based on their patient number
Assessment and Follow-up
Assessments included standardized clinical photography objective scar severity scoring and patient-reported outcomes
Clinical examination assessed the types and severity of acne scars using validated scales such as the Acne Scar Assessment Scale ASAS Goodman and Baron scale ECCA grading scale and Investigator Global Assessment IGA using a 5-point scale for improvement
Patient satisfaction was measured using a 5-point scale from not satisfied to very satisfied The Facial Acne Scar Quality of Life FASQol tool was used to assess the impact on patients quality of life
Photos were taken using a Samsung Galaxy S10 Plus smartphone with a 12 MP telephoto lens
Participants were followed up at 4 8 and 12 weeks post-treatment
Outcome Measures
The primary outcome measure was the change in scar severity scores from baseline to follow-up visits
Secondary outcome measures included participant satisfaction scores improvement in scar texture and adverse events Comparisons between treatment modalities were also made
After subcision patients underwent the following treatments
Plasma Gel Therapy One half of the face was assigned to the plasma gel therapy group Plasma gel was prepared in two steps
Platelet Poor Plasma PPP Preparation Ten milliliters of venous blood were drawn from each patient and collected in sterile anticoagulant-equipped vacuum tubes The blood was centrifuged at 72 g for 15 minutes at room temperature then the plasma layer was centrifuged again for 5 minutes at 1006 g to yield 65 ml of PPP and 05 ml of platelet-rich plasma PRP
Gel Formation The PPP syringes were placed in a hot water bath 60-100C for 1 minute then in a cold bath 8-0C for 1 minute to turn the plasma into a viscous gel The gel was injected into the scarred areas immediately after subcision
Thread Treatment The other side of the face received PDO thread treatment Cog PDO threads were inserted using a blunt-tipped cannula in a Z pattern within the scarred areas filling the pockets created by subcision
Randomization Subcision was performed on both sides of the face followed by either plasma gel injection or thread insertion Patients were randomly assigned to either modality based on their patient number
Assessment and Follow-up
Assessments included standardized clinical photography objective scar severity scoring and patient-reported outcomes
Clinical examination assessed the types and severity of acne scars using validated scales such as the Acne Scar Assessment Scale ASAS Goodman and Baron scale ECCA grading scale and Investigator Global Assessment IGA using a 5-point scale for improvement
Patient satisfaction was measured using a 5-point scale from not satisfied to very satisfied The Facial Acne Scar Quality of Life FASQol tool was used to assess the impact on patients quality of life
Photos were taken using a Samsung Galaxy S10 Plus smartphone with a 12 MP telephoto lens
Participants were followed up at 4 8 and 12 weeks post-treatment
Outcome Measures
The primary outcome measure was the change in scar severity scores from baseline to follow-up visits
Secondary outcome measures included participant satisfaction scores improvement in scar texture and adverse events Comparisons between treatment modalities were also made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None