- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471854
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marilyn Sameh Abd Almalak, Assistant lecturer
- Phone Number: +201226310521
- Email: marilyn.sameh@aun.edu.eg
Study Contact Backup
- Name: Eman Mohamed Kamal Elsayed Youssef, Professor
- Phone Number: +201005369338
- Email: emankyoussef@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: nanofat injection and platelet rich fibrin
(21 patients) single nanofat injection on both sides of the face, followed by platelet rich fibrin injection on one side of face monthly for 3 months.
|
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 20 ml luer-lock syringe, finally subcutaneous fat started to be expelled in the syringe The aspirated fat will be centrifuged at 3000 rpm for 3 min to concentrate fat particles Then the lipoaspirate will be mechanically emulsified using 2.4, 1.4, and 1.2 mm Luer-to-Luer Tulip connectors via 30 mechanical passes between two syringes through each connector, respectively A filtration process will be performed using a special filter containing a mesh with ultra-fine holes to remove debris
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.
|
|
Active Comparator: nanofat injection and miconeedling
(21 patients)- single nanofat injection on both sides of the face, followed by microneedling on one side of face monthly for 3 months.
|
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 20 ml luer-lock syringe, finally subcutaneous fat started to be expelled in the syringe The aspirated fat will be centrifuged at 3000 rpm for 3 min to concentrate fat particles Then the lipoaspirate will be mechanically emulsified using 2.4, 1.4, and 1.2 mm Luer-to-Luer Tulip connectors via 30 mechanical passes between two syringes through each connector, respectively A filtration process will be performed using a special filter containing a mesh with ultra-fine holes to remove debris
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Comaprison among different treatment modalities will be done by 1-Goodman and Baron qualitative score : Goodman and Baron qualitative Scale for each side of the face will be performed for all groups by counting and grading scars at the baseline and 3 months after the last session, then comparing its values before the start of treatment and 3 months after the last session Grade 1 (Macular): Erythematous, hyperpigmented, or hypopigmented flat marks. Grade 2 (Mild): Mild atrophic or hypertrophic scars, usually concealable with makeup or hair. Grade 3 (Moderate): Obvious, noticeable scars that are not easily hidden, sometimes showing "ice-pick" characteristics. Grade 4 (Severe): Marked, deep, or severe scarring, or widespread, severe scarring. Is nanofat injection alone effective in treamtment of post acne scars or when combined with either platelt rich fibrin or microneedling is better? |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's satisfaction
Time Frame: 6 months
|
Patients will be asked at their last follow-up visit to rate their improvement and aesthetic appearance of scars on each side of the face using the quartile scale (slight improvement <25%, moderate improvement 25%-49%, significant improvement 50%-74%, and marked improvement ≥75%)
|
6 months
|
|
Pain assessment
Time Frame: 6 months
|
All patients will be asked to rate their pain on a scale of 0 to 10. 0 means no pain and 10 means the worst pain.
Pain will be evaluated using a numerical 0 to 10 scale (0 = no pain, 1-4 = mild pain, 5-7 = moderate pain, and 8-10 = severe pain
|
6 months
|
|
Histopathological evaluation
Time Frame: 6 months
|
A 2 mm punch biopsies will be obtained from representative atrophic scars on each facial side at baseline (before treatment) and at the end of 6 months. All biopsies will be taken from scar tissue only. Biopsy sites will be standardized by selecting scars of comparable clinical type and severity on both cheeks. Specimens will include epidermis and extend to the mid-dermis.Tissues will be fixed in 10% neutral buffered formalin, routinely processed, and embedded in paraffin. Serial sections (4-5 μm) will be prepared. The following stains will be performed:
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Radwa Mohamed Abdel Moniem Bakr, Associate professor
- Study Director: Howida Omar Mahmoud, Associate professor
- Study Director: Eman Mohamed Kamal Elsayed Youssef, Professor, unafflilted
Publications and helpful links
General Publications
- Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- 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.
- Fabbrocini G, Fardella N, Monfrecola A, Proietti I, Innocenzi D. Acne scarring treatment using skin needling. Clin Exp Dermatol. 2009 Dec;34(8):874-9. doi: 10.1111/j.1365-2230.2009.03291.x. Epub 2009 May 22.
- 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.
- Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rageh MA, El-Khalawany M, Ibrahim SMA. Autologous nanofat injection in treatment of scars: A clinico-histopathological study. J Cosmet Dermatol. 2021 Oct;20(10):3198-3204. doi: 10.1111/jocd.14363. Epub 2021 Aug 6.
- Klinger M, Klinger F, Caviggioli F, Maione L, Catania B, Veronesi A, Giannasi S, Bandi V, Giaccone M, Siliprandi M, Barbera F, Battistini A, Lisa A, Vinci V. Fat Grafting for Treatment of Facial Scars. Clin Plast Surg. 2020 Jan;47(1):131-138. doi: 10.1016/j.cps.2019.09.002. Epub 2019 Oct 21.
- Miao L, Ma Y, Liu Z, Ruan H, Yuan B. Modern techniques in addressing facial acne scars: A thorough analysis. Skin Res Technol. 2024 Feb;30(2):e13573. doi: 10.1111/srt.13573.
- Kravvas G, Al-Niaimi F. A systematic review of treatments for acne scarring. Part 1: Non-energy-based techniques. Scars Burn Heal. 2017 Mar 30;3:2059513117695312. doi: 10.1177/2059513117695312. eCollection 2017 Jan-Dec.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nanofat in post acne scars
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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