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

Официальное название

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.

Обзор

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

Вмешательства

• Процедура subcision 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.

Первичные конечные точки

• Percent change in atrophic acne scar topography [Срок оценки: Baseline, Week 12, and Week 24 (3 months after last injection).]
• Change in Goodman and Baron Quantitative Score. [Срок оценки: Baseline, Week 12, and Week 24 (3 months after last injection).]

Вторичные конечные точки (9)

• Patient and Observer Scar Assessment Scale (POSAS) - Observer Scale [Срок оценки: Baseline, Week 12, and Week 24 (3 months after last injection).]
• Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale [Срок оценки: Baseline, Week 12, and Week 24 (3 months after last injection)]
• Proportion of patients with clinically significant POSAS improvement [Срок оценки: Week 12 and Week 24]
• Proportion of patients with \ge30% improvement in Goodman and Baron score [Срок оценки: Week 12 and Week 24.]
• Change in total atrophic acne scar counts [Срок оценки: Baseline, Week 12, and Week 24.]
• Success rate based on Scar Global Assessment (SGA) [Срок оценки: Week 12 and Week 24.]
• Patient Satisfaction Score [Срок оценки: Week 12 and Week 24.]
• Absolute values of scar topography [Срок оценки: Baseline, Week 12, and Week 24.]
• Absolute values of Goodman and Baron Quantitative Score [Срок оценки: Baseline, Week 12, and Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University, Dermatology Department — Cairo

Идентификаторы

NCT: NCT07547956 · MS-376-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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