Determination of complete response rate of intrlesional immunotherapy with candida antigens in the treatment of Molluscum contagiosum
Design
Clinical trial with no control group, single group, with no blinding , carried out on patient's with Molluscum contagiosum
Settings and conduct
This study is conducted on 40 patients with Molluscum contagiosum referring to the Dermatology Clinic of Ghaem and Imam Reza Hospitals in Mashhad. Monthly immunotherapy continues for a maximum of 6 treatment sessions.The criteria of response to treatment are: full recovery, which means all molecums have disappeared and no response, meaning that all molluscums have remained during the study. The relative response is considered when one or more lesions (but not all the lesions) have recovered.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Acquisition of patient and parents' consent
Exclusion criteria : 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
Intervention groups
Patients with negative prick test are selected and intra dermal injection in the forearm is carried out with 0.1 cc of CANDIN. The appearance or non-appearance and the post-injection reaction rate after 48-72 hours are recorded.The intra lesional injection rate of Candida antigens is determined by the intra dermal reaction size. 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 treatment. Patients are evaluated at the beginning of the study and in each treatment period, and the number and level of molluscums are recorded.
Main outcome variables
Complete response, relative response and no-response to the treatment of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180411039265N2
Registration date:2019-03-02, 1397/12/11
Registration timing:registered_while_recruiting
Last update:2019-03-02, 1397/12/11
Update count:0
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Naghmeh Zabolinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3845
Email address
zabolinejadng@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-15, 1397/05/24
Expected recruitment end date
2019-12-15, 1398/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of complete-response rate of intralesional immunotherapy with Candida antigen for the treatment of molluscum contagiosum
Public title
Investigation of complete-response rate of intralesional immunotherapy with Candida antigen for the treatment of molluscum contagiosum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
acquisition of patient and parents' consent
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.MUMS.fm.REC.1397.106
Health conditions studied
1
Description of health condition studied
Molluscum contagiosum
ICD-10 code
B08.1
ICD-10 code description
Molluscum contagiosum
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.