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IRCT20180411039265N2 IRCT 2019-03-02 Mashhad University of Medical Sciences Investigation of complete-response rate of intralesional immunotherapy with Candida antigen for the treatment of molluscum contagiosum Investigation of complete-response rate of intralesional immunotherapy with Candida antigen for the treatment of molluscum contagiosum 2018-08-15 anticipated 40 Complete https://irct.ir/trial/37174 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Molluscum contagiosum. Intervention group: Firstly, scratch test (prick test) with Candida antigen is performed on all patients in order to determine the level of type 1 hypersensitivity to Candida. Patients with negative prick test are selected to reduce the risk of anaphylaxis and then intra dermal injection in forearm is carried out with one tenth of a cc (0.1 cc) of one of the Candida antigen derivatives called CANDIN, which is a cellular immune stimulant. The appearance or non-appearance and the post-injection reaction rate after 48-72 hours are recorded. Positive reaction confirmation requires redness and stiffening for at least 5 mm diameter. The intra lesional injection rate of Candida antigens is determined by the intra dermal reaction size and is as follows : injection of 0.3 cc in the case of stiffening (induration) with 5-20 mm diameter, 0.2 cc injection in case of stiffening with 20-40 mm diameter, 0.1 cc injection in case of stiffening with more than 40 mm diameter. In case of a large lesion, it is possible to inject all the required volume inside it. But if there are only small lesions, there is a need for injection in 3 lesions to reach the full volume. Monthly immunotherapy continues until the mucosal lesions completely disappear, or for molluscums with less or no-response, it is repeated up to a maximum of 6 sessions of therapy. Patients are evaluated at the beginning of the study and in each treatment period, and the number and level of molluscums are recorded. During follow-up, response or non-response to treatment and reduction of the number of molluscums in the case of relative response to treatment are recorded.. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Saman Afkhami Ardakani
Imam Reza Hospital, Imam Reza Square, Ebn_e_Sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2020 Afkhamias951@mums.ac.ir Mashhad University of Medical Sciences scientific Naghmeh Zabolinejad
Imam Reza Hospital, Imam Reza Square, Ebn_e_Sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5731 zabolinejadng@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) acquisition of patient and parents' consent no limit no limit Both Pregnant or lactating women Violation of initial safety conditions or iatrogenic decease Infection with HIV1 Increased sensitivity to Candida antigen Reception of any treatment in relation to molluscum during the past month B08.1 Molluscum contagiosum Treatment - Drugs Intervention group: Firstly, scratch test (prick test) with Candida antigen is performed on all patients in order to determine the level of type 1 hypersensitivity to Candida. Patients with negative prick test are selected to reduce the risk of anaphylaxis and then intra dermal injection in forearm is carried out with one tenth of a cc (0.1 cc) of one of the Candida antigen derivatives called CANDIN, which is a cellular immune stimulant. The appearance or non-appearance and the post-injection reaction rate after 48-72 hours are recorded. Positive reaction confirmation requires redness and stiffening for at least 5 mm diameter. The intra lesional injection rate of Candida antigens is determined by the intra dermal reaction size and is as follows : injection of 0.3 cc in the case of stiffening (induration) with 5-20 mm diameter, 0.2 cc injection in case of stiffening with 20-40 mm diameter, 0.1 cc injection in case of stiffening with more than 40 mm diameter. In case of a large lesion, it is possible to inject all the required volume inside it. But if there are only small lesions, there is a need for injection in 3 lesions to reach the full volume. Monthly immunotherapy continues until the mucosal lesions completely disappear, or for molluscums with less or no-response, it is repeated up to a maximum of 6 sessions of therapy. Patients are evaluated at the beginning of the study and in each treatment period, and the number and level of molluscums are recorded. During follow-up, response or non-response to treatment and reduction of the number of molluscums in the case of relative response to treatment are recorded. Complete-response, relative-response or no-response to the treatment of lesions. Timepoint: Monthly immunotherapy continues until the mucosal lesions completely disappear and for molluscums with less or no-response, it continues for a maximum of 6 treatment sessions. Method of measurement: Number and level of molluscums are written down. Mashhad University of Medical Sciences Approved 2018-05-09 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)