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

To compare the efficacy of Stromal Vascular Fraction and Platelet Rich Plasma, both combined with non cross linked hyaluronic acid, in improving atrophic acne scars after fractional carbon dioxide laser therapy

A randomized, single blinded, phase 2 clinical trial with a comparison group and split face design on 30 patients. Allocation will be performed using permuted blocks of four

This randomized clinical trial with a split face design will be conducted on patients with atrophic acne scars at Hazrat Fatemeh Educational and Therapeutic Center for Reconstructive and Plastic Surgery. After obtaining informed consent, patients will receive fractional carbon dioxide laser therapy followed by injection of Stromal Vascular Fraction combined with non cross linked hyaluronic acid on one side of the face and Platelet Rich Plasma combined with non cross linked hyaluronic acid on the opposite side. Allocation of interventions will be randomized. The outcome assessor will be blinded to the intervention type on each side of the face.

Inclusion criteria: Patients with atrophic acne scars, candidates for fractional carbon dioxide laser therapy, with informed consent. Exclusion criteria: Diseases affecting wound healing, active skin diseases, medications affecting immunity or skin healing, pregnancy or breastfeeding, allergy to study materials

Intervention group: Injection of Stromal Vascular Fraction combined with non cross linked hyaluronic acid on one side of the face. Comparison group: Injection of Platelet Rich Plasma combined with non cross linked hyaluronic acid on the opposite side of the face

Improvement of atrophic acne scars based on clinical evaluation; patient satisfaction with treatment outcome

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.

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.