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Towards Formulation of Highly Acidic Active Ingredients: Development of Clinically Effective Concentrated Trichloroacetic Acid Gel for Wart Management

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Abstract

Common warts are benign skin lesions caused by the human papillomavirus. Although they are usually not harmful, they can cause pain, depending on their location. While many modalities are available for treatment of warts, none is a gold standard, and many are not affordable and/or have suboptimal outcomes. Trichloroacetic acid (TCA) is a chemical tissue-destroying agent used as a highly concentrated solution for wart management. While available and efficient, it is difficult to handle as the solution spreads to tissue surrounding the wart causing pain and burning. Hence, we developed a new polymer-based gel of high TCA content (100% w/v). Gels were formed successfully as hydroxyethyl cellulose (HEC) and chitosan were used to impart viscosity and bioadhesion. Formulae of different concentrations were tested for their physical properties, and the optimal formulation was selected for clinical evaluation. A combination of 3% HEC and 2% chitosan provided optimal viscosity and limited water content and have acceptable stability. The efficacy and safety of the biweekly application of TCA gel were evaluated in 30 patients. The clinical study revealed gel’s efficacy and tolerability; half of the patients showed a complete cure, and 90% showed improvement within 6 weeks. Only 10–12% of the patients reported side effects. In summary, transforming TCA solution into a gel enabled its application and handling in a practical manner by physicians and patients alike, while maintaining its efficacy as a tissue-destroying agent. Moreover, it is economic and easy to apply, rendering it a promising formulation for similar conditions requiring controlled tissue ablation.

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Authors and Affiliations

  1. Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Deraya University, Minya, Egypt

    Abdelrahman M. Helmy

  2. Pharmaceutical Engineering and 3D Printing (PharmE3D) Lab, Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, 78712, USA

    Abdelrahman M. Helmy

  3. Department of Dermatology, Faculty of Medicine, Minia University, Minia, Egypt

    Shimaa Shehata Ahmed & Hossam M. Abdel-Wahab

  4. Department of Clinical Pharmacy, Faculty of Pharmacy, Deraya University, Minia, Egypt

    Ramy M. El Sabaa

  5. Department of Clinical Pharmacy, Faculty of Pharmacy, Menoufia University, Menoufia, Egypt

    Ramy M. El Sabaa

  6. Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt

    Sara A. Abouelmagd

  7. Institute for Drug Development and Innovation Research, Assiut University, Assiut, Egypt

    Sara A. Abouelmagd

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  1. Abdelrahman M. Helmy
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  2. Shimaa Shehata Ahmed
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  4. Hossam M. Abdel-Wahab
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  5. Sara A. Abouelmagd
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Contributions

A.M.H and S.A.A. were responsible for formulation, gel evaluation, and data analysis. S.S.A. and H.M.A. were responsible for protocol development, patient enrollment, clinical data collection, and analysis. R.M.E. contributed to clinical data collection and analysis. First draft of the manuscript was written by S.A.A and H.M.A. All the authors read and approved the final manuscript.

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Correspondence to Hossam M. Abdel-Wahab or Sara A. Abouelmagd.

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Helmy, A.M., Ahmed, S.S., Sabaa, R.M.E. et al. Towards Formulation of Highly Acidic Active Ingredients: Development of Clinically Effective Concentrated Trichloroacetic Acid Gel for Wart Management. AAPS PharmSciTech 24, 160 (2023). https://doi.org/10.1208/s12249-023-02615-7

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