Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars

Overview

To compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars.

Detailed description

Inflammatory acne lesions may result in permanent scars . Atrophic, hypertrophic, and keloidal scars are the categories into which acne scars can be generically divided . Atrophic scarring represents about 75% of acne scars and is subdivided into icepick, rolling, and boxcar scars .

Currently, there is no standard treatment for atrophic acne scars. Various treatment approaches have been used to improve the appearance of acne scars, with varying degrees of success \]. Traditional treatment methods include lasers, platelet-rich plasma (PRP), excisions, skin abrasion, chemical peeling, tissue filling, microneedling, thread lifting, and photodynamic therapy, while emerging therapies such as mesenchymal stem cells (MSCs) and their derivatives are also available .

Autologous fat grafting is an alternative modality in managing post acne scarring . In 2013, Tonnard was the first person who described the technique of obtaining nano fat. Its capacity for regeneration is attributable to the adipose tissue-derived stem cells (ADSCs) and stromal vascular fraction (SVF) cells that promote blood vessel formation and the secretion of growth factors that impede fibrosis and inflammation, speed up wound healing, and improve skin texture.

Platelet-rich fibrin (PRF), the second-generation platelet concentrate, was developed for the purpose of removing anticoagulants and for better release of growth factors. A rapid and short centrifugation procedure is needed for separation of blood layers before clotting. A fibrin matrix is formed in the platelet-rich layer entrapping platelets and leukocytes in it. This matrix makes the release of growth factors slow and prolonged comparing with PRP .

Microneedling (MN) therapy has been used as a treatment for various dermatological conditions, including scar tissue . This technique involves repetitive skin puncture using sterile microneedles to disrupt dermal collagen that connects the scar tissue. The needle will penetrate the stratum corneum and generate small holes with minimal damage to the epidermis. This process will provoke the regeneration of growth factors to stimulate collagen and elastin production . To the best of our knowledge, platelet rich fibrin and microneedling have never been tried with nanofat injection in the treatment of atrophic post acne scars and our study is the first to do so.

Interventions

• Procedure nanofat injecion
  potential donor sites for fat graft including the lower abdomen, flanks, hips and thighs. After injection of 2 cm of lidocaine hydrochloride 2% intradermally at site of entry blade will be stabbed to open access for harvesting cannula to access subcutaneous fat. Tumescent anesthesia will be infiltrated in multidirectional plane to numb the whole area and waiting for 20 minutes, then starting to push the harvesting cannula in and out with slight suction pressure created by pulling the plunger of
• Procedure Platelet rich fibrin
  PRF will be produced by single spin centrifugation of 10 ml of venous blood collected in plain glass tube without anticoagulant at 700 rpm for 3 min. The upper layer, yellow to orange colored fluid, will be collected as fluid PRF. Approximately, 1 ml Fluid PRF can be separated from 10 ml blood. * 45 min before the session, local anesthetic cream containing mixture of lidocaine and prilocaine will be applied to one side of the face, then will be sterilized by alcohol before starting the treatmen
• Procedure Microneedling
  Microneedling will be done by Derma electric-pen, and needle cartridge with 12 needles. Needle length will be adjusted at 2.5 mm and speed level 4 (blue color). * 45 min before the session, local anesthetic cream containing mixture of lidocaine and prilocaine will be applied to one side of the face, then will be sterilized by alcohol before starting the treatment. Dermapen will be moved in the four directions, vertically, horizontally, diagonally right and left, over one side of the face withou

Primary outcome measures

• compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars. [Time frame: 6 months]

Secondary outcome measures (3)

• Patient's satisfaction [Time frame: 6 months]
• Pain assessment [Time frame: 6 months]
• Histopathological evaluation [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Patients older than 18 years of both sexes with moderate to severe atrophic facial acne scars on both cheeks

Exclusion criteria

• 1\. Patients' age <18 or >45 years 2. Pregnant and lactating women 3. active inflammatory acne or active infection in the treatment area. 4. treatment of the targeted study sites within 2 months 5. history of chronic diseases (autoimmune diseases, bleeding disorders, taking anticoagulant therapy or aspirin) 6. history of hypertrophic scars or keloid formation tendency. 7. patients with unrealistic expectations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8. PMID 19674646
• Majid I, Imran S. Fractional CO2 Laser Resurfacing as Monotherapy in the Treatment of Atrophic Facial Acne Scars. J Cutan Aesthet Surg. 2014 Apr;7(2):87-92. doi: 10.4103/0974-2077.138326. PMID 25136208
• Diab NAF, Ibrahim AM, Abdallah AM. Fluid Platelet-Rich Fibrin (PRF) Versus Platelet-Rich Plasma (PRP) in the Treatment of Atrophic Acne Scars: A Comparative Study. Arch Dermatol Res. 2023 Jul;315(5):1249-1255. doi: 10.1007/s00403-022-02511-3. Epub 2022 Dec 15. PMID 36520210
• Miron RJ, Chai J, Zhang P, Li Y, Wang Y, Mourao CFAB, Sculean A, Fujioka Kobayashi M, Zhang Y. A novel method for harvesting concentrated platelet-rich fibrin (C-PRF) with a 10-fold increase in platelet and leukocyte yields. Clin Oral Investig. 2020 Aug;24(8):2819-2828. doi: 10.1007/s00784-019-03147-w. Epub 2019 Dec 2. PMID 31788748
• Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7. PMID 16936550
• Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x. PMID 17199653
• Lee KC, Bamford A, Gardiner F, Agovino A, Ter Horst B, Bishop J, Sitch A, Grover L, Logan A, Moiemen NS. Investigating the intra- and inter-rater reliability of a panel of subjective and objective burn scar measurement tools. Burns. 2019 Sep;45(6):1311-1324. doi: 10.1016/j.burns.2019.02.002. Epub 2019 Jul 19. PMID 31327551
• Alster TS, Li MKY. Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. Plast Reconstr Surg. 2020 Feb;145(2):358-364. doi: 10.1097/PRS.0000000000006462. PMID 31985622

Identifiers

NCT: NCT07471854 · Nanofat in post acne scars

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗