Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split-face treatment arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent 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 | 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) | Baseline, Week 12, and Week 24 (3 months after last injection). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) - Observer Scale | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University, Dermatology Department | Recruiting | Cairo | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 | 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 | 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 | 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) | 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 | 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 | 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 | Comparison of absolute values of the Goodman and Baron Quantitative Score for rolling acne scars. | Baseline, Week 12, and Week 24 |