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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Acne Vulgaris, Atrophic Acne Scar
- 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 group | Role | What they receive |
|---|---|---|
| Subcision plus Plasma gel | Active comparator | The 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 threads | Active comparator | Cog 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.
Clinical improvement
The improvement was assessed using the Goodman and Baron scale.
Measured: after 3 month of the procedure
Clinical improvement
The improvement was assessed using the ECCA grading scale.
Measured: after 3 month of the procedure
Clinical improvement
The improvement was assessed using the physician global assessment.
Measured: 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.
Measured: after 3 month of the procedure
Secondary outcomes (2)
Patients satisfaction.
participant satisfaction score, improvement in scar texture.
Measured: 3 months from the procedure
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.
- First posted30 Aug 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sameh Sarsik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Sarsik, Tanta University
- Investigators
- Wael Saudi, MD, Principal investigator, Misr University for Science and Technology
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars: a Split-face
- ClinicalTrials.gov ID
- NCT06580691
- Acronym / sponsor ID
- 36264PR126/3/23
- Conditions
- Acne Vulgaris, Atrophic Acne Scar
- Keywords
- Acne vulgaris, Atrophic acne scars, Threads, Polydioxanone, Plasma gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sameh SarsikUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- both male and female patients with atrophic acne scars
| Arm | Type | Receives |
|---|---|---|
| Subcision plus Plasma gel | Active comparator | Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threadsThe gel was injected into the scarred areas immediately after subcision. |
| Subcision plus Cog PDO threads | Active comparator | Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threadsCog PDO threads were inserted using a blunt-tipped cannula in a "Z pattern" within the scarred areas, filling the pockets created by subcision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old, with atrophic acne scars on both sides of their faces of any severity.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threadsPlasma 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. | Procedure or surgery | Subcision plus Cog PDO threads, Subcision plus Plasma gel |
Primary outcome
Clinical improvement
Time frame: after 3 month of the procedure
The improvement was assessed using the Goodman and Baron scale.
Clinical improvement
Time frame: after 3 month of the procedure
The improvement was assessed using the ECCA grading scale.
Clinical improvement
Time frame: after 3 month of the procedure
The improvement was assessed using the physician global assessment.
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.
2 secondary outcomes
Patients satisfaction.
Time frame: 3 months from the procedure
Side effects of the procedures.
Time frame: During 3 months from the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Saudi, MD principal investigator
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
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.