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2000
Volume 11, Issue 1
  • ISSN: 2667-3371
  • E-ISSN: 2667-338X

Abstract

Background/Indroduction

Actinic keratosis (AK) is a precancerous skin condition caused by abnormal growth of epidermal keratinocytes. Current treatments, like 5-fluorouracil (5-FU) cream, have limitations. Rosemary extract has shown anticancer and antioxidant properties, enhancing the effects of 5-FU. Nanofibers are a potential drug delivery system due to their unique properties. Thus, this study aimed to investigate the efficacy of 5-FU and rosemary extract-loaded nanofibers in AK treatment.

Methods

Polymeric nanofibers loaded with 5-FU and rosemary extract were created using electrospinning. A randomized controlled double-blinded clinical trial was conducted on AK patients, divided into three groups: Group A (nanofibers with 5% 5-FU and rosemary extract), Group B (nanofibers with 5% 5-FU), and Group C (5% 5-FU cream). Improvement, satisfaction, and side effects were assessed using visual analogue scale (VAS) scores and the modified Investigator Global Improvement Score.

Results and Discussion

Group A exhibited significantly higher global improvement scores compared to Group B ( value<0.001). Group A also had the highest VAS score, indicating greater patient satisfaction. Side effects were lowest in Group A and highest in Group C.

Conclusion

This randomized double-blinded clinical trial suggests that nanofibers loaded with 5-FU and rosemary extract (Group A) are more effective in improving AK lesions compared to nanofibers with 5-FU alone (Group B) and 5-FU cream (Group C). Group A also showed higher patient satisfaction and fewer side effects. The combination of 5-FU and rosemary extract in nanofibers holds promise as an alternative treatment for AK. Further studies are needed to validate these findings and investigate the long-term effects of the treatment.

Clinical Trial Registration Number

IRCT20210118050067N1.

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2025-03-05
2025-09-28

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References

  1. JansenM.H.E. KesselsJ.P.H.M. NelemansP.J. KouloubisN. AritsA.H.M.M. van PeltH.P.A. QuaedvliegP.J.F. EssersB.A.B. SteijlenP.M. Kelleners-SmeetsN.W.J. MosterdK. Randomized trial of four treatment approaches for actinic keratosis.N. Engl. J. Med.20193801093594610.1056/NEJMoa181185030855743
     [Google Scholar]
  2. CeilleyR.I. JorizzoJ.L. Current issues in the management of actinic keratosis.J. Am. Acad. Dermatol.2013681Suppl. 1S28S3810.1016/j.jaad.2012.09.05123228304
     [Google Scholar]
  3. MarksR. RennieG. SelwoodT. Malignant transformation of solar keratoses to squamous cell carcinoma.Lancet1988331858979579710.1016/S0140‑6736(88)91658‑32895318
     [Google Scholar]
  4. de OliveiraE.C.V. da MottaV.R.V. PantojaP.C. IlhaC.S.O. MagalhãesR.F. GaladariH. LeonardiG.R. Actinic keratosis – Review for clinical practice.Int. J. Dermatol.201958440040710.1111/ijd.1414730070357
     [Google Scholar]
  5. SegattoM.M. DornellesS.I.T. SilveiraV.B. FrantzG.O. Comparative study of actinic keratosis treatment with 3% diclofenac sodium and 5% 5-fluorouracil.An. Bras. Dermatol.201388573273810.1590/abd1806‑4841.2013208324173178
     [Google Scholar]
  6. AritsA.H.M.M. MosterdK. EssersB.A.B. SpoorenbergE. SommerA. De RooijM.J.M. van PeltH.P.A. QuaedvliegP.J.F. KrekelsG.A.M. van NeerP.A.F.A. RijzewijkJ.J. van GeestA.J. SteijlenP.M. NelemansP.J. Kelleners-SmeetsN.W.J. Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: A single blind, non-inferiority, randomised controlled trial.Lancet Oncol.201314764765410.1016/S1470‑2045(13)70143‑823683751
     [Google Scholar]
  7. LoveW.E. BernhardJ.D. BordeauxJ.S. Topical imiquimod or fluorouracil therapy for basal and squamous cell carcinoma: A systematic review.Arch. Dermatol.2009145121431143810.1001/archdermatol.2009.29120026854
     [Google Scholar]
  8. Gracia-CazañaT. GonzálezS. GilaberteY. Resistance of nonmelanoma skin cancer to nonsurgical treatments. Part I: Topical treatments.Actas Dermosifiliogr.2016107973073910.1016/j.adengl.2016.08.01627436800
     [Google Scholar]
  9. González-VallinasM. MolinaS. VicenteG. de la CuevaA. VargasT. SantoyoS. García-RiscoM.R. FornariT. RegleroG. Ramírez de MolinaA. Antitumor effect of 5-fluorouracil is enhanced by rosemary extract in both drug sensitive and resistant colon cancer cells.Pharmacol. Res.201372616810.1016/j.phrs.2013.03.01023557932
     [Google Scholar]
  10. NaghibiF. MosaddeghM. MotamedS.M. GhorbaniA. Labiatae family in folk medicine in Iran: From ethnobotany to pharmacology.Iran. J. Pharm. Res.2005426379
     [Google Scholar]
  11. RotblattM. Herbal medicine: expanded commission E monographs.American College of Physicians2000
     [Google Scholar]
  12. AndradeJ.M. FaustinoC. GarciaC. LadeirasD. ReisC.P. RijoP. Rosmarinus officinalis L.: An update review of its phytochemistry and biological activity.Future Sci. OA201844FSO28310.4155/fsoa‑2017‑012429682318
     [Google Scholar]
  13. AnantharajuP.G. GowdaP.C. VimalambikeM.G. MadhunapantulaS.V. An overview on the role of dietary phenolics for the treatment of cancers.Nutr. J.20161519910.1186/s12937‑016‑0217‑227903278
     [Google Scholar]
  14. PrakashV. Terpenoids as cytotoxic compounds: A perspective.Pharmacogn. Rev.2018122416617610.4103/phrev.phrev_3_18
     [Google Scholar]
  15. HeunisT.D.J. DicksL.M.T. Nanofibers offer alternative ways to the treatment of skin infections.J. Biomed. Biotechnol.20102010111010.1155/2010/51068220798871
     [Google Scholar]
  16. JamaliR. GhassamiE. DinaniM.S. GhasemiR. MirianM. Fabrication and optimization of electrospun polymeric nanofibers loaded with 5-fluorouracil and rosemary extract.Pharm. Nanotechnol.202210323224610.2174/221173851066622062315355235747975
     [Google Scholar]
  17. DesaiS RentonBJ KothareA Clinical evaluation of the secret RF device for treating neck and facial wrinkles and global improvement of skin quality.2020Available from: https://secretbycutera.eu/wp-content/uploads/2023/03/AP003573-rA-Siperstein-Secret-RF-Whitepaper.pdf
  18. LiuX. XuH. ZhangM. YuD.G. Electrospun medicated nanofibers for wound healing.Membranes2021111077010.3390/membranes1110077034677536
     [Google Scholar]
  19. OpanasopitP. Sila-onW. RojanarataT. NgawhirunpatT. Fabrication and properties of capsicum extract-loaded PVA and CA nanofiber patches.Pharm. Dev. Technol.20131851140114710.3109/10837450.2012.72700423033938
     [Google Scholar]
  20. Abu-Al-BasalM.A. Healing potential of Rosmarinus officinalis L. on full-thickness excision cutaneous wounds in alloxan-induced-diabetic BALB/c mice.J. Ethnopharmacol.2010131244345010.1016/j.jep.2010.07.00720633625
     [Google Scholar]
  21. de MacedoL.M. SantosÉ.M. MilitãoL. TundisiL.L. AtaideJ.A. SoutoE.B. MazzolaP.G. Rosemary (Rosmarinus officinalis L., syn Salvia rosmarinus Spenn.) and its topical applications: A review.Plants20209565110.3390/plants905065132455585
     [Google Scholar]
  22. NejatiH. FarahpourM.R. NagadehiM.N. Topical Rosemary officinalis essential oil improves wound healing against disseminated Candida albicans infection in rat model.Comp. Clin. Pathol.20152461377138310.1007/s00580‑015‑2086‑z
     [Google Scholar]
  23. Pérez-SánchezA. Barrajón-CatalánE. CaturlaN. CastilloJ. Benavente-GarcíaO. AlcarazM. MicolV. Protective effects of citrus and rosemary extracts on UV-induced damage in skin cell model and human volunteers.J. Photochem. Photobiol. B2014136121810.1016/j.jphotobiol.2014.04.00724815058
     [Google Scholar]
  24. WengL. XieJ. Smart electrospun nanofibers for controlled drug release: Recent advances and new perspectives.Curr. Pharm. Des.201521151944195910.2174/138161282166615030215195925732665
     [Google Scholar]
  25. LovenK. SteinL. FurstK. LevyS. Evaluation of the efficacy and tolerability of 0.5% fluorouracil cream and 5% fluorouracil cream applied to each side of the face in patients with actinic keratosis.Clin. Ther.2002246990100010.1016/S0149‑2918(02)80012‑112117087
     [Google Scholar]
  26. LevyS. FurstK. ChernW. A pharmacokinetic evaluation of 0.5% and 5% fluorouracil topical cream in patients with actinic keratosis.Clin. Ther.200123690892010.1016/S0149‑2918(01)80078‑311440290
     [Google Scholar]
  27. GolestannejadZ. KhozeimehF. MehrasaM. MirzaeeiS. SarfarazD. A novel drug delivery system using acyclovir nanofiber patch for topical treatment of recurrent herpes labialis: A randomized clinical trial.Clin. Exp. Dent. Res.20228118419010.1002/cre2.51234865318
     [Google Scholar]
  28. MeamarR. CheginiS. VarshosazJ. AminorroayaA. AminiM. SiavoshM. Alleviating neuropathy of diabetic foot ulcer by co-delivery of venlafaxine and matrix metalloproteinase drug-loaded cellulose nanofiber sheets: Production, in vitro characterization and clinical trial.Pharmacol. Rep.202173380681910.1007/s43440‑021‑00220‑833826133
     [Google Scholar]
  29. AkbariJ. SaeediM. FarzinD. Morteza-SemnaniK. EsmailiZ. Transdermal absorption enhancing effect of the essential oil of Rosmarinus officinalis on percutaneous absorption of Na diclofenac from topical gel.Pharm. Biol.201553101442144710.3109/13880209.2014.98485525853969
     [Google Scholar]
  30. AmerS.S. MamdouhW. NasrM. ElShaerA. PolycarpouE. Abdel-AzizR.T.A. SammourO.A. Quercetin loaded cosm-nutraceutical electrospun composite nanofibers for acne alleviation: Preparation, characterization and experimental clinical appraisal.Int. J. Pharm.202261212130910.1016/j.ijpharm.2021.12130934801653
     [Google Scholar]
  31. BaydarH. ÖzkanG. ErbaşS. AltındalD. Yield, chemical composition and antioxidant properties of extracts and essential oils of sage and rosemary depending on seasonal variationsI International Medicinal and Aromatic Plants Conference on Culinary HerbsAntalya, Turkey,
     [Google Scholar]
/content/journals/adctra/10.2174/0126673371349369250217053128
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Efficacy of Nanofiber Mats Loaded with 5-Fluorouracil and Rosemary
Appl. Drug Resea., Clin. Trials and Regu. Affa. 11, E26673371349369 (2025); https://doi.org/10.2174/0126673371349369250217053128
/content/journals/adctra/10.2174/0126673371349369250217053128
/content/journals/adctra/10.2174/0126673371349369250217053128
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  • Article Type:     Research Article
Keyword(s): 5-fluorouracil; Actinic keratosis; biopsy; double-blind randomized controlled trial; nanofibers; rosemary extract

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