NCT07471854

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
May 2026Dec 2027

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 9, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (3)

  • Patient's satisfaction

    6 months

  • Pain assessment

    6 months

  • Histopathological evaluation

    6 months

Study Arms (2)

nanofat injection and platelet rich fibrin

ACTIVE COMPARATOR

(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.

Procedure: nanofat injecionProcedure: Platelet rich fibrin

nanofat injection and miconeedling

ACTIVE COMPARATOR

(21 patients)- single nanofat injection on both sides of the face, followed by microneedling on one side of face monthly for 3 months.

Procedure: nanofat injecionProcedure: Microneedling

Interventions

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

nanofat injection and miconeedlingnanofat injection and 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 treatment. * one side of face will be treated by intradermal injection of fluid PRF. 0.1 mL of fluid PRF will be injected intradermally into the atrophic scars with 1.5 to 2 cm interval using insulin syringe followed by gentle massaging of the treated area. * The treatment will be started immediately after separation of PRF to avoid clot formation. The patients will receive three treatment sessions with 4 weeks interval

nanofat injection and platelet rich fibrin
MicroneedlingPROCEDURE

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 without pressing. * The patients will receive three treatment sessions with 4 weeks interval

nanofat injection and miconeedling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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: 19674646BACKGROUND
  • 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: 25136208BACKGROUND
  • 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: 36520210BACKGROUND
  • 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: 31788748BACKGROUND
  • 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: 16936550BACKGROUND
  • 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: 17199653BACKGROUND
  • 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: 31327551BACKGROUND
  • 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: 31985622BACKGROUND
  • 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.

    PMID: 19187989BACKGROUND
  • 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.

    PMID: 34357682BACKGROUND
  • 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.

    PMID: 23783059BACKGROUND
  • 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.

    PMID: 31739889BACKGROUND
  • 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.

    PMID: 38303407BACKGROUND
  • 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.

    PMID: 29799567BACKGROUND
  • 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.

    PMID: 19486041BACKGROUND

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • Radwa Mohamed Abdel Moniem Bakr, Associate professor

    STUDY DIRECTOR
  • Howida Omar Mahmoud, Associate professor

    STUDY DIRECTOR
  • Eman Mohamed Kamal Elsayed Youssef, Professor

    unafflilted

    STUDY DIRECTOR

Central Study Contacts

Marilyn Sameh Abd Almalak, Assistant lecturer

CONTACT

Eman Mohamed Kamal Elsayed Youssef, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Nanofat injection
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03