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Viral Infections
Published in Ayşe Serap Karadağ, Lawrence Charles Parish, Jordan V. Wang, Roxburgh's Common Skin Diseases, 2022
Management: Many nongenital warts in healthy individuals can spontaneously regress. Almost all common warts (~90%) resolve within 5 years. Treatment is initiated based on patient preference. Multiple treatment rounds or methods may be needed for a satisfactory resolution. Genital warts have high recurrence rates likely secondary to surrounding subclinical infection. Treatment modalities include two approaches: destruction and induction of local immune reactions. Destruction methods include topical treatments, cryotherapy, curettage, and light electrocautery, intralesional bleomycin, laser, and surgical removal. Topical treatments, such as salicylic acid preparations, podophyllin, cantharidin, and 5-fluorouracil (5-FU) cream, have shown success for common warts. For genital warts, topical treatments such as podophyllotoxin, imiquimod, sinecatechins, and trichloroacetic (TCA) acid are used. Immunotherapy to induce a local immune reaction in common warts includes topical dinitrochlorobenzene (DNCB), squaric acid, diphencyprone, imiquimod, and intralesional candida, mumps antigen, or bacillus Calmette Guérin (BCG). Imiquimod is Food and Drug Administration (FDA)–approved to treat genital warts.
Efficacy, Quality, Safety and Toxicity of Herbal Medicine
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
In the European Union (EU), HMPs are officially recognised as medicines based on directives set out in 2001 and 2004. On the other hand, in the United States (US), HMPs are still classified as botanical products and are controlled by food legislation due to their chemical complexity. In 2008, the FDA approved its first botanical drug Veregen® (sinecatechins) derived from green tea for application on genital and perianal warts. In 2012, Crofelemer was approved for the symptomatic relief of diarrhoea in HIV/AIDs patients under antiretroviral therapy. Despite the reluctance to register HMPs as official medicine, it is widely recognised today that they can be important alternative sources of medicines for chronic diseases such as cancer and heart conditions. For example Chinese medicine–based PHY906 has passed phase I and II trials for cancer and Dantonic® underwent phase III trial for angina in the United States (Chen et al. 2008; Yen et al. 2008; Fan et al. 2012).
Ethnobotany Post-Genomic Horizons and Multidisciplinary Approaches for Herbal Medicine Exploration: An Overview
Published in T. Pullaiah, K. V. Krishnamurthy, Bir Bahadur, Ethnobotany of India, 2017
Manickam Tamil Selvi, Ankanagari Srinivas
Consistency in high quality, effectiveness of treatment, safety and patient affordability are the major player in the drug development. The principles underlying in translational research is the standard bottom up bench to bed side. Clinical studies should be conducted in parallel. A well-defined methodology for standardized assessment of the quality, efficacy, and safety is must before starting of any basic project (Yang et al., 2014). For topical treatment of external genital and perianal warts Veregen (sinecatechins) is the first FDA approved herbal drug in the year of 2006 and the second is Fulyzaq (crofelemer) for symptomatic relief of noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy in 2012. It shows that herbal drugs can be developed to comply the FDA standards of quality, safety, and efficacy (Lee, 2015).
How can we improve the safe use of herbal medicine and other natural products? A clinical pharmacologist mission
Published in Expert Review of Clinical Pharmacology, 2020
Elena Y. Enioutina, Kathleen M. Job, Lubov V. Krepkova, Michael D. Reed, Catherine M. Sherwin
Botanical drugs are often extracts prepared medicinal plants, algae, and/or macroscopic fungi (Figure 1) [4]. Highly purified or chemically modified NP constituents are not considered to be botanical drugs and are classified as conventional drugs. The pharmacological properties of a botanical drug cannot always be ascribed to a specific constituent. Furthermore, the pharmacological effects of botanical multi-constituent drugs are most likely the result of the combined activity of all constituents present in the extract. Specific recommendations for botanical drug production, safety, and efficacy testing were clarified in a ‘Guidance for Industry: Botanical Drug Products’ initially published by the Center for Drug Evaluation and Research Botanical Review team in 2004 and revised in 2016 [1,5]. The U.S. FDA has received > 800 IND and PINDs in the last 34 years [5]. The marketing of botanical drugs is labor-intensive and expensive [5,20]; therefore, only two botanical drugs have currently fulfilled the directives given in the Guidance for Botanical Drugs (i.e. Veregen® (sinecatechins) ointment and Mytesi® (crofelemer)) [2,5]. Veregen® (sinecatechins) is a water extract of green tea leaves from Camellia sinensis (L.) intended for the cutaneous treatment of external genital and perianal warts in immunocompetent patients aged ≥18 years [21]. The extract consists of eight known catechins (i.e. Epigallocatechin gallate, Epicatechin, Epigallocatechin, Epicatechin gallate, Gallocatechin gallate, Gallocatechin, Catechin gallate, and Catechin) and other constituents such as gallic acid, caffeine, and theobromine. Crofelemer is a botanical drug isolated from the red sap of the Croton lechleri tree intended for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy [22].
Actinic keratosis: where do we stand and where is the future going to take us?
Published in Expert Opinion on Emerging Drugs, 2020
Philipp Cramer, Eggert Stockfleth
Sinecatechins development might face the problem that even though a link between HPV infection and AK has been established, there is currently no data which could give us an idea whether all, most or just a few AK lesions are connected to HPV infection or whether this link is coincidental. Another issue might be that there currently are no studies on whether HPV infection if positive then is linked to the entire field cancerization or is limited to a smaller field or patches. For us to evaluate the full potential of this treatment angle further studies are needed.
Investigational drugs currently in phase II clinical trials for actinic keratosis
Published in Expert Opinion on Investigational Drugs, 2019
Flavia Lozzi, Caterina Lanna, Mauro Mazzeo, Virginia Garofalo, Vincenzo Palumbo, Sara Mazzilli, Laura Diluvio, Alessandro Terrinoni, Luca Bianchi, Elena Campione
The biological activity of sinecatechins most probably involves the activation of cellular immune reactions, blockage of cell cycle, induction of apoptosis and inhibition of HPV gene expression [84,85]. According to recent findings, sinecatechins may also be used to protect against photocarcinogenesis [85]. Current evidence might lead to new therapeutic possibilities and a new promising molecule. Combined and sequential treatments can be considered to improve efficacy and reduce AEs leading to a better patient compliance.