Subcision With Injection of Poly Deoxyribonucleotide Versus Subcision With Injection of Non-cross Linked Hyaluronic Acid in Rolling Acne Scars Treatment.

May 14, 2026 updated by: Islam Abdelkareem Ismail Abujarbou, Cairo University

Subcision With Injection of Poly Deoxyribonucleotide Versus Subcision With Injection of Non-cross Linked Hyaluronic Acid in Rolling Acne Scars Treatment : A Split Face Randomized Controlled Clinical Trial.

The aim of this study is to evaluate and compare the efficacy and safety of two different injectable agents combined with subcision for treating rolling acne scars. In this split-face clinical trial, each participant will receive subcision on both sides of the face. One side will then be treated with an injection of Polydeoxyribonucleotide (PDRN), while the other side will receive an injection of non-cross linked Hyaluronic acid (HA). The clinical outcomes and improvement in scar appearance will be assessed and compared between both treatments

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University, Dermatology Department
        • Contact:
          • dermatology department cairo university
          • Phone Number: 0235674835
          • Email: info@cu.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Moderate to severe mainly rolling acne scars per validated scale (Goodman & Baron Grade 3-4)
  2. Scars must be bilaterally distributed, allowing for split-face comparison
  3. Stable acne (no active nodulocystic lesions, pustules, or recent outbreaks for ≥6 months)
  4. No scar treatments (e.g., fillers, laser, microneedling) within the past 12 months
  5. All skin types.
  6. Both genders above 18 years old

Exclusion Criteria:

  1. Systemic retinoid treatment within the last 6 months
  2. Active inflammatory acne
  3. Lidocaine sensitivity
  4. Pregnancy and lactation
  5. Severe systemic illness or malignancy
  6. Use of anticoagulant or antiplatelet medications (unless cleared) Use of oral isotretinoin within the past 6 month
  7. Herpes libialis, bacterial infection, other infections such as HBV, HCV or HIV
  8. Tendency to keloid formation
  9. Allergy to fish and salmon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: split-face treatment arm
Each participant will receive two different treatments: one side of the face will be treated with subcision followed by injection of polydeoxyribonucleotide, while the contralateral side will be treated wit subcision followed by injection of non-cross linked hyaluronic acid
Procedure: subcision with PDRN vs HA injection
Each participant will receive two different treatments on each side of the face. One side will be treated with subcision followed by PDRN injection, while the other side will be treated with subcision followed by non-cross linked Hyaluronic Acid injection. Clinical assessment and 3D image analysis will be used for evaluation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent change in atrophic acne scar topography
Time Frame: Baseline, Week 12, and Week 24 (3 months after last injection).
Percent change from baseline in acne scar area, volume, and maximum depth as assessed by Antera 3D image analysis
Baseline, Week 12, and Week 24 (3 months after last injection).
Change in Goodman and Baron Quantitative Score.
Time Frame: Baseline, Week 12, and Week 24 (3 months after last injection).
Mean change in the Goodman and Baron Quantitative Score for rolling acne scars. The score categorizes severity as: Mild (1 to 6), Moderate (7 to 15), and Severe (16 or above)
Baseline, Week 12, and Week 24 (3 months after last injection).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale (POSAS) - Observer Scale
Time Frame: Baseline, Week 12, and Week 24 (3 months after last injection).
Mean change in POSAS Observer Scale score from baseline.
Baseline, Week 12, and Week 24 (3 months after last injection).
Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale
Time Frame: Baseline, Week 12, and Week 24 (3 months after last injection)
Mean change in POSAS Patient Scale score from baseline.
Baseline, Week 12, and Week 24 (3 months after last injection)
Proportion of patients with clinically significant POSAS improvement
Time Frame: Week 12 and Week 24
Percentage of patients achieving \ge30% improvement in total POSAS score.
Week 12 and Week 24
Proportion of patients with \ge30% improvement in Goodman and Baron score
Time Frame: Week 12 and Week 24.
Percentage of subjects achieving \ge30% improvement in the Goodman and Baron Quantitative Score.
Week 12 and Week 24.
Change in total atrophic acne scar counts
Time Frame: Baseline, Week 12, and Week 24.
Absolute change in total atrophic scar counts and Scar Global Assessment (SGA) using a 5-point scale (0 = clear to 4 = severe)
Baseline, Week 12, and Week 24.
Success rate based on Scar Global Assessment (SGA)
Time Frame: Week 12 and Week 24.
Proportion of subjects achieving an SGA score of "clear" or "almost clear" and at least a 2-grade improvement from baseline.
Week 12 and Week 24.
Patient Satisfaction Score
Time Frame: Week 12 and Week 24.
Proportion of patients achieving clinically meaningful improvement in satisfaction, defined as a \ge2-point increase on a 10-point Visual Analog Scale (VAS).
Week 12 and Week 24.
Absolute values of scar topography
Time Frame: Baseline, Week 12, and Week 24.
Comparison of absolute values of acne scar area, volume, and maximum depth as assessed by Antera 3D imaging
Baseline, Week 12, and Week 24.
Absolute values of Goodman and Baron Quantitative Score
Time Frame: Baseline, Week 12, and Week 24
Comparison of absolute values of the Goodman and Baron Quantitative Score for rolling acne scars.
Baseline, Week 12, and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-376-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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