Skip to main content

Advertisement

SpringerLink
Log in

A topical gel of tea tree oil nanoemulsion containing adapalene versus adapalene marketed gel in patients with acne vulgaris: a randomized clinical trial

  • Original Paper
  • Published:
Archives of Dermatological Research Aims and scope Submit manuscript

Abstract

Adapalene is used for treatment of acne vulgaris, a common dermatological disease. Nano-based carriers have been developed to improve solubility and bioavailability of adapalene and other acne treatment drugs. In our previous report, tea tree oil nanoemulsion containing adapalene gel (TTO NE + ADA Gel) showed appropriate physical and biological properties such as stability, viscosity, pH, size, morphology and biocompatibility in an animal model. The present study was designed to assess efficacy and safety of the TTO NE + ADA Gel in comparison with 0.1% adapalene marketed gel (ADA Marketed Gel). A total of 100 patients were randomized to receive TTO NE + ADA Gel or ADA Marketed Gel, once daily at night, for 12 weeks. Analysis for efficacy was conducted by acne lesion count (total, inflammatory and non-inflammatory) and acne severity index at weeks 4, 8 and 12 using generalized estimating equation along with the safety assessments in each measurement for assessing dryness, erythema, burning sensation and irritation. Significantly better reduction in total, inflammatory, and non-inflammatory acne lesions were reported for TTO NE + ADA Gel as compared to the ADA Marketed Gel overall and on each measurement occasion (p value  < 0.001 for all). Mean acne severity index also reduced with TTO NE + ADA Gel significantly in comparison with ADA Marketed Gel (p value  < 0.001). Dryness was the most common adverse effect reported in both groups and it was higher in TTO NE + ADA Gel group. In conclusion, TTO NE + ADA Gel compared to ADA Marketed Gel appears more effective in the treatment of acne vulgaris, with no important change in adverse effects.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Nguyen CM, Koo J, Cordoro KM (2016) Psychodermatologic effects of atopic dermatitis and acne: a review on self-esteem and identity. Pediatr Dermatol 33(2):129–135

    Article  Google Scholar 

  2. Najafi-Taher R, Amani A (2017) Nanoemulsions: colloidal topical delivery systems for antiacne agents. a mini-review. Nanomed Res J 2(1):49–56

    CAS  Google Scholar 

  3. Garg T (2016) Current nanotechnological approaches for an effective delivery of bio-active drug molecules in the treatment of acne. Artificial Cells Nanomed Biotechnol 44(1):98–105

    Article  CAS  Google Scholar 

  4. Ricci F, Masini F, Fossati B, Frascione P, De Waure C, Capizzi R et al (2016) Combination therapy with hydrogen peroxide (4%) salicylic acid (0. 5%) and D-panthenol (4%): efficacy and skyn tolerability in common acne vulgaris during sun exposure period. Euro Rev Med Pharmacol Sci. 20(2):232–6

    CAS  Google Scholar 

  5. Akarsu S, Fetil E, Yücel F, Gül E, Güneş AT (2012) Efficacy of the addition of salicylic acid to clindamycin and benzoyl peroxide combination for acne vulgaris. J Dermatol 39(5):433–8

    Article  CAS  Google Scholar 

  6. Seidler EM, Kimball AB (2010) Meta-analysis comparing efficacy of benzoyl peroxide, clindamycin, benzoyl peroxide with salicylic acid, and combination benzoyl peroxide/clindamycin in acne. J Am Acad Dermatol 63(1):52–62

    Article  CAS  Google Scholar 

  7. Aytekin M, Gursoy RN, Ide S, Soylu EH, Hekimoglu S (2013) Formulation and characterization of liquid crystal systems containing azelaic acid for topical delivery. Drug Dev Ind Pharm 39(2):228–239

    Article  CAS  Google Scholar 

  8. Shah KA, Date AA, Joshi MD, Patravale VB (2007) Solid lipid nanoparticles (SLN) of tretinoin: potential in topical delivery. Int J Pharm 345(1):163–171

    Article  CAS  Google Scholar 

  9. Mandawgade SD, Patravale VB (2008) Development of SLNs from natural lipids: application to topical delivery of tretinoin. Int J Pharm 363(1):132–138

    Article  CAS  Google Scholar 

  10. Liu J, Hu W, Chen H, Ni Q, Xu H, Yang X (2007) Isotretinoin-loaded solid lipid nanoparticles with skin targeting for topical delivery. Int J Pharm 328(2):191–195

    Article  CAS  Google Scholar 

  11. Münster U, NakamuraNachname C, Haberland A, Jores K, Mehnert W, Rummel S et al (2005) RU 58841-myristate–prodrug development for topical treatment of acne and androgenetic alopecia. Die Pharmazie-An Int J Pharmaceut Sci 60(1):8–12

    Google Scholar 

  12. Štecová J, Mehnert W, Blaschke T, Kleuser B, Sivaramakrishnan R, Zouboulis CC et al (2007) Cyproterone acetate loading to lipid nanoparticles for topical acne treatment: particle characterisation and skin uptake. Pharm Res 24(5):991–1000

    Article  Google Scholar 

  13. Layegh P, Mosallaei N, Bagheri D, Jaafari MR, Golmohammadzadeh S (2013) The efficacy of isotretinoin-loaded solid lipid nanoparticles in comparison to Isotrex® on acne treatment. Nanomed J 1(1):38–47

    Google Scholar 

  14. Domínguez-Delgado CL, Rodríguez-Cruz IM, Escobar-Chávez JJ, Calderón-Lojero IO, Quintanar-Guerrero D, Ganem A (2011) Preparation and characterization of triclosan nanoparticles intended to be used for the treatment of acne. Eur J Pharm Biopharm 79(1):102–107

    Article  Google Scholar 

  15. Jean-Thierry Simonnet OS, Sylvie Legret (2002) Nanoemulsion Based On Oxyethylenated Or Non-Oxyethylenated Sorbitan Fatty Esters And Its Uses In The Cosmetics, Dermatological And/Or Ophtalmological Fields Us 6,335,022 B1

  16. Jean-Thierry Simonnet OS, Sylvie legret (2002) Nanoemulsion based on ethyleneoxide and propylene oxide block copolymer and its uses in the cosmetics, dermatological and/or ophtalmological fields. Us 6,464,990 b2

  17. Jean-Thierry Simonnet OS, Sylvie Legret (2004) Nanoemulsion based on sugar fatty esters and on sugar fatty ethers and its uses in the cosmetics, dermatological and/or ophtalmological fields. US 6,689,371 b1

  18. Alain Ribier J-TS, Sylvie Legret (1998) Transparent nanoemulsion less than 100 nm based on fluid non-ionic amphiphilic lipids and use in cosmetic or in dermopharmaceuticals. US 5,753,241

  19. Esmaeili F, Rajabnejhad S, Partoazar AR, Mehr SE, Faridi-Majidi R, Sahebgharani M et al (2016) Anti-inflammatory effects of eugenol nanoemulsion as a topical delivery system. Pharm Dev Technol 21(7):887–893

    Article  CAS  Google Scholar 

  20. Azizi M, Esmaeili F, Partoazar A, Ejtemaei Mehr S, Amani A (2017) Efficacy of nano-and microemulsion-based topical gels in delivery of ibuprofen: an in vivo study. J Microencapsul 34(2):195–202

    Article  CAS  Google Scholar 

  21. Najafi-Taher R, Ghaemi B, Amani A (2018) Delivery of adapalene using a novel topical gel based on tea tree oil nano-emulsion: permeation, antibacterial and safety assessments. Eur J Pharm Sci 120:142–151

    Article  CAS  Google Scholar 

  22. Chandrashekhar B, Anitha M, Ruparelia M, Vaidya P, Aamir R, Shah S et al (2015) Tretinoin nanogel 0.025% versus conventional gel 0.025% in patients with acne vulgaris: a randomized, active controlled, multicentre, parallel group, phase IV clinical trial. J Clin Diagn Res. https://doi.org/10.7860/JCDR/2015/10663.5469

    Article  PubMed  PubMed Central  Google Scholar 

  23. Enshaieh S, Jooya A, Siadat AH, Iraji F (2007) The efficacy of 5% topical tea tree oil gel in mild to moderate acne vulgaris: a randomized, double-blind placebo-controlled study. Indian J Dermatol Venereol Leprol 73(1):22

    Article  Google Scholar 

  24. Irby CE, Yentzer BA, Feldman SR (2008) A review of adapalene in the treatment of acne vulgaris. J Adolesc Health 43(5):421–424

    Article  Google Scholar 

  25. Hammer K (2015) Treatment of acne with tea tree oil (melaleuca) products: a review of efficacy, tolerability and potential modes of action. Int J Antimicrob Agents 45(2):106–110

    Article  CAS  Google Scholar 

  26. Raza K, Singh B, Singla S, Wadhwa S, Garg B, Chhibber S et al (2013) Nanocolloidal carriers of isotretinoin: antimicrobial activity against Propionibacterium acnes and dermatokinetic modeling. Mol Pharm 10(5):1958–1963

    Article  CAS  Google Scholar 

  27. Thiboutot D, Pariser DM, Egan N, Flores J, Herndon JH Jr, Kanof NB et al (2006) Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial. J Am Acad Dermatol. 54(2):242–50

    Article  Google Scholar 

  28. Thielitz A, Lux A, Wiede A, Kropf S, Papakonstantinou E, Gollnick H (2015) A randomized investigator blind parallel group study to assess efficacy and safety of azelaic acid 15% gel vs adapalene 0.1% gel in the treatment and maintenance treatment of female adult acne. J Euro Acad Dermatol Venereol. 29(4):789–96

    Article  CAS  Google Scholar 

  29. Prasad S, Mukhopadhyay A, Kubavat A, Kelkar A, Modi A, Swarnkar B et al (2012) Efficacy and safety of a nano-emulsion gel formulation of adapalene 0 1% and clindamycin 0.1% combination in acne vulgaris: a randomized, open label, active-controlled, multicentric, phase IV clinical trial. Indian J Dermatol Venereol Leprol 78(4):459

    Article  Google Scholar 

  30. Freyre EA, Rebaza RM, Sami DA, Lozada CP (1998) The prevalence of facial acne in Peruvian adolescents and its relation to their ethnicity. J Adolesc Health 22(6):480–484

    Article  CAS  Google Scholar 

Download references

Acknowledgments

This project was supported by Tehran University of Medical Sciences (TUMS), grant No. 94-01-87-28505.

Author information

Authors and Affiliations

  1. Department of Medical Nanotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran

    Roqya Najafi-Taher & Amir Amani

  2. Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran

    Aarefeh Jafarzadeh kohneloo

  3. Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran

    Aarefeh Jafarzadeh kohneloo

  4. Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Vahid Eslami Farsani, Neda Mehdizade Rayeni & Amirhooshang Ehsani

  5. Department of Pharmaceutics and Nanotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Hamid Reza Moghimi

  6. Natural Products and Medicinal Plants Research Center, North Khorasan University of Medical Sciences, Bojnurd, Iran

    Amir Amani

Authors
  1. Roqya Najafi-Taher
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Aarefeh Jafarzadeh kohneloo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Vahid Eslami Farsani
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Neda Mehdizade Rayeni
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hamid Reza Moghimi
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Amirhooshang Ehsani
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Amir Amani
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Amirhooshang Ehsani or Amir Amani.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Najafi-Taher, R., Jafarzadeh kohneloo, A., Eslami Farsani, V. et al. A topical gel of tea tree oil nanoemulsion containing adapalene versus adapalene marketed gel in patients with acne vulgaris: a randomized clinical trial. Arch Dermatol Res 314, 673–679 (2022). https://doi.org/10.1007/s00403-021-02267-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00403-021-02267-2

Keywords

Search

Navigation