- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547956
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- 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
-
-
-
Cairo, Egypt
- Recruiting
- Cairo University, Dermatology Department
-
Contact:
- dermatology department cairo university
- Phone Number: 0235674835
- Email: info@cu.edu.eg
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Moderate to severe mainly rolling acne scars per validated scale (Goodman & Baron Grade 3-4)
- Scars must be bilaterally distributed, allowing for split-face comparison
- Stable acne (no active nodulocystic lesions, pustules, or recent outbreaks for ≥6 months)
- No scar treatments (e.g., fillers, laser, microneedling) within the past 12 months
- All skin types.
- Both genders above 18 years old
Exclusion Criteria:
- Systemic retinoid treatment within the last 6 months
- Active inflammatory acne
- Lidocaine sensitivity
- Pregnancy and lactation
- Severe systemic illness or malignancy
- Use of anticoagulant or antiplatelet medications (unless cleared) Use of oral isotretinoin within the past 6 month
- Herpes libialis, bacterial infection, other infections such as HBV, HCV or HIV
- Tendency to keloid formation
- 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 |
Intervention / Treatment |
|---|---|
|
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
|
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
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
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.
|
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Change in total atrophic acne scar counts
Time Frame: Baseline, Week 12, and Week 24.
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Absolute change in total atrophic scar counts and Scar Global Assessment (SGA) using a 5-point scale (0 = clear to 4 = severe)
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Baseline, Week 12, and Week 24.
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Success rate based on Scar Global Assessment (SGA)
Time Frame: Week 12 and Week 24.
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Proportion of subjects achieving an SGA score of "clear" or "almost clear" and at least a 2-grade improvement from baseline.
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Week 12 and Week 24.
|
|
Patient Satisfaction Score
Time Frame: Week 12 and Week 24.
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Proportion of patients achieving clinically meaningful improvement in satisfaction, defined as a \ge2-point increase on a 10-point Visual Analog Scale (VAS).
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Week 12 and Week 24.
|
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Absolute values of scar topography
Time Frame: Baseline, Week 12, and Week 24.
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Comparison of absolute values of acne scar area, volume, and maximum depth as assessed by Antera 3D imaging
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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
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)
October 20, 2025
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
July 20, 2026
Study Registration Dates
First Submitted
April 17, 2026
First Submitted That Met QC Criteria
April 17, 2026
First Posted (Actual)
April 23, 2026
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID 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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