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OpenTrials
Completed

NCT Number: NCT06580691

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

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.

Primary outcomes

  1. Clinical improvement

    Time frame: after 3 month of the procedure

    The improvement was assessed using the Goodman and Baron scale.

  2. Clinical improvement

    Time frame: after 3 month of the procedure

    The improvement was assessed using the ECCA grading scale.

  3. Clinical improvement

    Time frame: after 3 month of the procedure

    The improvement was assessed using the physician global assessment.

  4. Clinical improvement

    Time frame: after 3 month of the procedure

    The improvement was assessed using the FASQoL questionnaire to assess the effect on patients quality of life.

Secondary outcomes

  1. Patients satisfaction.

    Time frame: 3 months from the procedure

    participant satisfaction score, improvement in scar texture.

  2. Side effects of the procedures.

    Time frame: During 3 months from the procedure

    patients reporting of adverse events.

Sponsors and collaborators

Lead sponsor

Sameh Sarsik

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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