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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Cairo University, Dermatology Department
Cairo, Egypt
RECRUITINGPercent change in atrophic acne scar topography
Percent change from baseline in acne scar area, volume, and maximum depth as assessed by Antera 3D image analysis
Time frame: Baseline, Week 12, and Week 24 (3 months after last injection).
Change in Goodman and Baron Quantitative Score.
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)
Time frame: Baseline, Week 12, and Week 24 (3 months after last injection).
Patient and Observer Scar Assessment Scale (POSAS) - Observer Scale
Mean change in POSAS Observer Scale score from baseline.
Time frame: Baseline, Week 12, and Week 24 (3 months after last injection).
Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale
Mean change in POSAS Patient Scale score from baseline.
Time frame: Baseline, Week 12, and Week 24 (3 months after last injection)
Proportion of patients with clinically significant POSAS improvement
Percentage of patients achieving \\ge30% improvement in total POSAS score.
Time frame: Week 12 and Week 24
Proportion of patients with \ge30% improvement in Goodman and Baron score
Percentage of subjects achieving \\ge30% improvement in the Goodman and Baron Quantitative Score.
Time frame: Week 12 and Week 24.
Change in total atrophic acne scar counts
Absolute change in total atrophic scar counts and Scar Global Assessment (SGA) using a 5-point scale (0 = clear to 4 = severe)
Time frame: Baseline, Week 12, and Week 24.
Success rate based on Scar Global Assessment (SGA)
Proportion of subjects achieving an SGA score of "clear" or "almost clear" and at least a 2-grade improvement from baseline.
Time frame: Week 12 and Week 24.
Patient Satisfaction Score
Proportion of patients achieving clinically meaningful improvement in satisfaction, defined as a \\ge2-point increase on a 10-point Visual Analog Scale (VAS).
Time frame: Week 12 and Week 24.
Absolute values of scar topography
Comparison of absolute values of acne scar area, volume, and maximum depth as assessed by Antera 3D imaging
Time frame: Baseline, Week 12, and Week 24.
Absolute values of Goodman and Baron Quantitative Score
Comparison of absolute values of the Goodman and Baron Quantitative Score for rolling acne scars.
Time frame: Baseline, Week 12, and Week 24
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