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Acne VulgarisNCT06580691

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

A study testing Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads in people with Acne Vulgaris and Atrophic Acne Scar, run by Sameh Sarsik at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acne Vulgaris, Atrophic Acne Scar
What is being tested?
Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to 5 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Department of Dermatology and Venereology, Faculty of Medicine, Tanta University

    Tanta, Gharbia Governorate, 31527

Other trials in Egypt

About this study

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.

Read the 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.

Being tested
Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads
Keywords
Acne vulgaris, Atrophic acne scars, Threads, Polydioxanone, Plasma gel
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threadsProcedure or surgery

    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.

Study groups in NCT06580691
Study groupRoleWhat they receive
Subcision plus Plasma gelActive comparatorThe gel was injected into the scarred areas immediately after subcision.
Receives: Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads
Subcision plus Cog PDO threadsActive comparatorCog PDO threads were inserted using a blunt-tipped cannula in a "Z pattern" within the scarred areas, filling the pockets created by subcision.
Receives: Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical improvement

    The improvement was assessed using the Goodman and Baron scale.

    Measured: after 3 month of the procedure

  2. Clinical improvement

    The improvement was assessed using the ECCA grading scale.

    Measured: after 3 month of the procedure

  3. Clinical improvement

    The improvement was assessed using the physician global assessment.

    Measured: after 3 month of the procedure

  4. Clinical improvement

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

    Measured: after 3 month of the procedure

Secondary outcomes (2)
  1. Patients satisfaction.

    participant satisfaction score, improvement in scar texture.

    Measured: 3 months from the procedure

  2. Side effects of the procedures.

    patients reporting of adverse events.

    Measured: During 3 months from the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2024
  2. Study start1 Jan 2023
  3. Primary completion30 Jun 2023
  4. Study completion5 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
both male and female patients with atrophic acne scars
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06580691
Sponsor's protocol ID
36264PR126/3/23
Status last verified
Aug 2024
First submitted
26 Aug 2024
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads in people with Acne Vulgaris and Atrophic Acne Scar, run by Sameh Sarsik at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement (time frame: after 3 month of the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.

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