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IRCT20260802070498N1 IRCT 2026-08-26 Iran University of Medical Sciences The Efficacy of Stromal Vascular Fraction (SVF) combined with Non-Cross-Linked Hyaluronic Acid on Atrophic Acne scars undergoing Fractional CO₂ Laser therapy Evaluation and comparison of the Efficacy of Stromal Vascular Fraction (SVF) Combined with Non-Cross-Linked Hyaluronic Acid Versus Platelet-Rich Plasma (PRP) combined with Non-Cross-Linked Hyaluronic Acid in the treatment of patients with atrophic acne scars undergoing fractional CO₂ Laser therapy 2026-09-11 anticipated 12 Complete https://irct.ir/trial/92190 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming the eligibility criteria and obtaining written informed consent, each patient will be randomly assigned to receive a combination of Stromal Vascular Fraction (SVF) and nanocross-linked Hyaluronic Acid (Luxiva) on one half of the face, while the contralateral half will receive a combination of Platelet-Rich Plasma (PRP) and nanocross-linked Hyaluronic Acid (Luxiva). The right or left side of the face will be randomly allocated to each intervention. Simple randomization will be used for allocation. The individual patient will be considered the unit of randomization. Stratified randomization will not be performed. One appropriate method for implementing the allocation process is the use of Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE). The allocation sequence will be prepared in advance, and each allocation will be placed in an opaque, sequentially numbered, and securely sealed envelope. The envelopes will be opened sequentially after the patient has met all eligibility criteria and provided informed consent, thereby ensuring appropriate allocation concealment, Blinding description: Participants will be blinded to the intervention allocated to each side of the face. Outcome assessment will be performed by an independent assessor who is blinded to the allocation of the interventions. Due to the nature of the procedures, the treating physician cannot be blinded because of the preparation and administration of SVF and PRP. The treating physician will not be involved in outcome assessment or data analysis. Data collection and outcome assessment will be performed by blinded personnel to minimize the risk of bias. 2 Atrophic acne scars. Intervention 1: Intervention group: Following fractional Carbon Dioxide (CO₂) laser treatment, one half of the patient’s face will receive an injection of Stromal Vascular Fraction (SVF) combined with nanocross-linked Hyaluronic Acid (Luxiva; manufactured by Atra Zist Aray). The SVF will be obtained from the patient’s autologous adipose tissue and, following preparation, will be combined with nanocross-linked Hyaluronic Acid and injected into the areas of atrophic acne scars.The consumable materials required for the intervention will be provided by Iran University of Medical Sciences. Intervention 2: Control group: On the opposite side of the face, following fractional carbon dioxide laser therapy, Platelet Rich Plasma combined with non cross linked hyaluronic acid will be injected. Platelet Rich Plasma will be prepared from the patient's autologous blood and, after processing, will be injected with non cross linked hyaluronic acid into areas with atrophic acne scars. This group will serve as the comparison group for evaluating the efficacy of Stromal Vascular Fraction. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fahime Sarjamei
Hazrat Fatemeh (S) Super Specialty Plastic and Reconstructive Surgery Teaching Hospital No. 21 Street, beside Shafaq Park, Seyed Jamaleddin Asadabadi Street (Yousef Abad), Tehran, Iran.
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 Drfahimesarjamei@gmail.com Iran University of Medical Sciences scientific Fahime Sarjamei
Hazrat Fatemeh (S) Super Specialty Plastic and Reconstructive Surgery Teaching Hospital No. 21 Street, beside Shafaq Park, Seyed Jamaleddin Asadabadi Street (Yousef Abad)
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 Drfahimesarjamei@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 45 years Presence of atrophic facial acne scars Mild to severe atrophic acne scars requiring fractional CO₂ laser therapy Willingness and ability to participate in the study and complete the follow-up period Provision of written informed consent No history of invasive acne scar treatments within the previous 6 months Eligibility to undergo fractional CO₂ laser therapy and the study interventions 18 years 45 years Both Active systemic or autoimmune diseases History of keloid or hypertrophic scars Use of anticoagulant drugs or systemic retinoids within the past six months Pregnancy or breastfeeding Active infection at the treatment site History of hypersensitivity to any of the materials used in SVF, PRP, and luxiva Treatment - Drugs Treatment - Drugs Intervention group: Following fractional Carbon Dioxide (CO₂) laser treatment, one half of the patient’s face will receive an injection of Stromal Vascular Fraction (SVF) combined with nanocross-linked Hyaluronic Acid (Luxiva; manufactured by Atra Zist Aray). The SVF will be obtained from the patient’s autologous adipose tissue and, following preparation, will be combined with nanocross-linked Hyaluronic Acid and injected into the areas of atrophic acne scars.The consumable materials required for the intervention will be provided by Iran University of Medical Sciences. Control group: On the opposite side of the face, following fractional carbon dioxide laser therapy, Platelet Rich Plasma combined with non cross linked hyaluronic acid will be injected. Platelet Rich Plasma will be prepared from the patient's autologous blood and, after processing, will be injected with non cross linked hyaluronic acid into areas with atrophic acne scars. This group will serve as the comparison group for evaluating the efficacy of Stromal Vascular Fraction Severity score of atrophic acne scars. Timepoint: Assessment of atrophic acne scar severity at baseline (before intervention), 3 months after treatment and 6 months after treatment. Method of measurement: Acne Scar Grading Scale assessed by a trained clinical evaluator blinded to the intervention type on each side of the face. Percentage of improvement in atrophic acne scars. Timepoint: Assessment of percentage of improvement in atrophic acne scars at baseline (before intervention), 3 months after treatment and 6 months after treatment. Method of measurement: Percentage of improvement in atrophic acne scars will be determined by comparison of standardized clinical photographs before and after treatment by a trained clinical evaluator blinded to the intervention type on each side of the face. Patient satisfaction with treatment outcome. Timepoint: Assessment of patient satisfaction with treatment outcome 6 months after intervention. Method of measurement: Patient satisfaction with treatment outcome will be assessed using a patient satisfaction questionnaire completed by the patient. Treatment related adverse events. Timepoint: From the time of intervention until 6 months after treatmentنحوه اندازه‌گیری. Method of measurement: Based on clinical examination and recording of adverse events reported by the patient. Iran University of Medical Sciences Approved 2026-06-22 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Adjacent to Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)