Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars: a Split-face

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris; Atrophic Acne Scar
• Intervention / Treatment: Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

Detailed Description

The treatment area was prepared by anesthetizing the acne-scarred region with a 2% lidocaine injection mixed with 1/1000 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 procedure's 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 6.5 ml of PPP and 0.5 ml of platelet-rich plasma (PRP).

Gel Formation: The PPP syringes were placed in a hot water bath (60-100°C) for 1 minute, then in a cold bath (8-0°C) 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Department of Dermatology and Venereology, Faculty of Medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients over 18 years old, with atrophic acne scars on both sides of their faces of any severity.

Exclusion Criteria:

• patients with keloidal tendencies or bleeding disorders.
• Participants with a history of recent isotretinoin use within 3 months
• Patients who underwent any procedure for treatment of acne scars during the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subcision plus Plasma gel; The gel was injected into the scarred areas immediately after subcision.	Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads; Plasma Gel: was injected into the scarred areas immediately after subcision. 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.
Active Comparator: Subcision plus Cog PDO threads; Cog PDO threads were inserted using a blunt-tipped cannula in a "Z pattern" within the scarred areas, filling the pockets created by subcision.	Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads; Plasma Gel: was injected into the scarred areas immediately after subcision. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	The improvement was assessed using the Goodman and Baron scale.	after 3 month of the procedure
Clinical improvement	The improvement was assessed using the ECCA grading scale.	after 3 month of the procedure
Clinical improvement	The improvement was assessed using the physician global assessment.	after 3 month of the procedure
Clinical improvement	The improvement was assessed using the FASQoL questionnaire to assess the effect on patients quality of life.	after 3 month of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients satisfaction.	participant satisfaction score, improvement in scar texture.	3 months from the procedure
Side effects of the procedures.	patients reporting of adverse events.	During 3 months from the procedure

Collaborators and Investigators

• Sponsor: Sameh Sarsik
• Investigators: Principal Investigator: Wael Saudi, MD, Misr University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Acne vulgaris; Polydioxanone; Atrophic acne scars; Threads; Plasma gel
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Atrophy
• Other Study ID Numbers: 36264PR126/3/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No