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NCT Number: NCT07547956

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

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

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Key information

Conditions

Atrophic Acne Scars

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Dermatology Department

Cairo, Egypt

Location status: Recruiting

Location contact

dermatology department cairo university

CONTACT

[email protected]

0235674835

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

subcision with PDRN vs HA injection

Procedure

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.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. 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).

  8. 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

  9. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
May 18, 2026

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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