Before you decide , you can talk to anyone you feel comfortable with about the research. There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have ques tions later, you can ask me, the st udy doctor or the staff. Importance of the research Intralesional i mmunotherapy is a newly emerged but more comfortable, efficacious and cost effective method of treatment of warts. Purpose of the research 1. To determine the efficacy of IL MMR vaccine in t he treatment of Wart 2. To determine the efficacy of IL Vitamin D in the treatment of wart 3. To compare the efficacy of IL MMR vaccine and IL Vitamin D Participant selection : We are inviting all the patient s attending dermatology OPD diagnosed as Warts. 37 Volu ntary Participation Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change. If you choose not to participate in this research project, you will be offered the treatment that is routinely offered in this hospital for treatment of your condition. Procedures and Protocol A preset proforma will be filled up for every patient which includes p ersonal data, past history, medical history, drug history, clinical data like site, size, number, distribution . A thorough clinical examination of the patients will be recorded . The session of injection will be done at 3 week ly intervals for a maxi mum of 5 sessions or until complete resolution of warts, whichever is earlier and thereafter monitoring will be done monthly for 3 months. Photograph of the lesions will be taken b efore the first treatment session, in every treatment session and 3 months after last session . In patients of group B who need 3 or more sessions, s erum vitamin D level will be measured after 20 days of 3rd dose and 1 month after the last dose to ensure safe monitoring . Direct or indirect benefits to participant, community or oth ers Compared to other destructive modalities, immunotherapy is more effective and comfortable for the patient as it obviates the need for individual treatment of each wart. In addition it has a lower rate of recurrence, avoids adverse effects such as scarr ing, is more cost -effective in multiple warts and decreases the time a physicia n has to spend on each patient. Further it can be easily made available in 38 periphery, hence the impact that it is going have becomes multifold especially in context of Nepal. Foreseeable Risks, discomfort or inconvenience to patient Side effects include pain during injection , flu-like symptoms, pruritus, burning sensation , edema , mild eryt hema, hyperpigmentation. Cost and source of investigations, drugs, and surgery Patient mus t bear the cost of drugs. However, the cost of measuring serum vitamin D level and injecting procedure will be free of charge and we investigator ourselves will be liable for this. If any adverse effects occur then the consultation charge will be free but patient must bear the drug charges if needed. Insurance coverage will be provided as per Social Health Insurance scheme of Nepal government. Confidentiality The information that we collect from this research project will be kept confidential. Information about you that will be collected during the research will be put away and no -one but the researchers will be able to see it. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information up with a lock and key. It will not be shared with or given to anyone except those working in the Department of Dermatology. Sharing the Results The knowledge that we get from doing this research will be published in a thesis paper and later may be published in a scientific research journal. 39 Right to Refuse or Withdraw You do not have to take part in this research if you do not wish to do so and refusing to participate will not affect your treatment at this clinic in any way. Y ou will still have all the benefits that you would otherwise have at this clinic. You may stop participating in the research at any time that you wish without losing any of your rights as a patient here. Your treatment at this clinic w ill not be affected i n any way. Whom to Contact If you have any questions you may ask me now or later, even after the study has started. If you wish to ask questions later, you may contact: Dr. Bibisha Baaniya BPKIHS, Dharan Email Address: cul.bibisha@gmail.com Phone no: 9841744777 40 Department of Dermatology and venereology BPKIHS, Dharan, Nepal Informed consent Name of the Candidate: Age: Gender: Address: Telephone no. Email: The content of the information sheet dated………… ………………that was provided have been read carefully by me/explained in detail to me, in a language that I comprehend, and I have fully understood the contents.