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

NCT ID: NCT06580691

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-05

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.

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.

Conditions

Acne Vulgaris; Atrophic Acne Scar

Keywords

Acne vulgaris; Atrophic acne scars; Threads; Polydioxanone; Plasma gel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subcision plus Plasma gel

The gel was injected into the scarred areas immediately after subcision.

Group Type: ACTIVE_COMPARATOR

Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sameh Sarsik

OTHER

Sponsor Role: lead

Responsible Party

Sameh Sarsik

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wael Saudi, MD

Role: PRINCIPAL_INVESTIGATOR

Misr University for Science and Technology

Locations

Department of Dermatology and Venereology, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

36264PR126/3/23

Identifier Type: -

Identifier Source: org_study_id