Atrophic Acne Scars
Conditions
Keywords
subcision, PDRN, Hyakuronic acid, atrophic acne scars
Brief summary
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
Interventions
PROCEDUREsubcision 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.
Sponsors
Cairo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in atrophic acne scar topography | 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 |
| Change in Goodman and Baron Quantitative Score. | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) - Observer Scale | Baseline, Week 12, and Week 24 (3 months after last injection). | Mean change in POSAS Observer Scale score from baseline. |
| Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale | Baseline, Week 12, and Week 24 (3 months after last injection) | Mean change in POSAS Patient Scale score from baseline. |
| Proportion of patients with clinically significant POSAS improvement | Week 12 and Week 24 | Percentage of patients achieving \\ge30% improvement in total POSAS score. |
| Proportion of patients with \ge30% improvement in Goodman and Baron score | Week 12 and Week 24. | Percentage of subjects achieving \\ge30% improvement in the Goodman and Baron Quantitative Score. |
| Change in total atrophic acne scar counts | 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) |
| Success rate based on Scar Global Assessment (SGA) | 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. |
| Patient Satisfaction Score | 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). |
| Absolute values of scar topography | Baseline, Week 12, and Week 24. | Comparison of absolute values of acne scar area, volume, and maximum depth as assessed by Antera 3D imaging |
| Absolute values of Goodman and Baron Quantitative Score | Baseline, Week 12, and Week 24 | Comparison of absolute values of the Goodman and Baron Quantitative Score for rolling acne scars. |
Countries
Egypt
Outcome results
None listed