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CTRI Number  CTRI/2018/08/015198 [Registered on: 06/08/2018] Trial Registered Retrospectively
Last Modified On: 02/08/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of potassium hydroxide and podophyllotoxin in the treatment of molluscum contagiosum  
Scientific Title of Study   An open –label, parallel group, randomized clinical trial to compare the efficacy and safety of 10% KOH and 0.5% Podophyllotoxin for the treatment of Molluscum Contagiosum 
Trial Acronym  KOHPDX 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niharika Ranjan Lal 
Designation  Clinical Tutor 
Affiliation  Department of Dermatology, Medical College, Kolkata 
Address  88, College Street.

Kolkata
WEST BENGAL
700073
India 
Phone  9007229293  
Fax    
Email  dr.niharika11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Niharika Ranjan Lal 
Designation  Clinical Tutor 
Affiliation  Medical College, Kolkata 
Address  88, College Street.

Kolkata
WEST BENGAL
700073
India 
Phone  9007229293  
Fax    
Email  dr.niharika11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niharika Ranjan Lal 
Designation  Clinical Tutor 
Affiliation  Department of Dermatology, Medical College, Kolkata 
Address  88, College Street.

Kolkata
WEST BENGAL
700073
India 
Phone  9007229293  
Fax    
Email  dr.niharika11@gmail.com  
 
Source of Monetary or Material Support  
10% KOH and 0.5% podophyllotoxin were prepared in the Pharmacy. cost was beared by the principal investigator. 
 
Primary Sponsor  
Name  Dr Niharika Ranjan Lal 
Address  88, College Street Medical College, Kolkata Kolkata 700073 
Type of Sponsor  Other [principal investigator self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niharika Ranjan Lal  Medical College, Kolkata  Department of Dermatology, 88, College Street.
Kolkata
WEST BENGAL 		 9007229293

dr.niharika11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Medical College, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Molluscum contagiosum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  KOH solution  10% KOH solution in aquaous base in a 10 ml dark coloured container  
Intervention  podophyllotoxin   0.5% podophyllotoxin paint in a 10 ml dark coloured container  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  patients of all ages and both sexes who are diagnosed with a MC infection (clinical diagnosis).
who have provided written informed consent for participation.
 
 
ExclusionCriteria 
Details  Immunocompromised patient (congenital or acquired).
Patient has received other topical treatment within the last month.
Pregnant and lactating women.
Patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy will be assessed in each of the areas detected in the previous visit. If there are new areas affected, they will be evaluated at the next visit. The primary outcome will be calculated for each of the affected areas, as an indicator variable: (There is a lesion in the area/No lesion in the area) at 6th week from baseline. Each patient will be considered cured if they have no lesions in any of the treated areas.  outcome will be assessed at 2nd, 4th and 6th weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary efficacy variables (secondary endpoints) will be calculated for each location as follows:
Number of lesions.
Extent of area affected.
Mean size of lesions
 		 6 wwek 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/10/2015 
Date of Study Completion (India) 31/10/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/10/2016 
Estimated Duration of Trial   Years="1"
Months="0"
Days="22" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published till date 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Title: An open label, parallel-group, randomized clinical trial to compare the efficacy and safety of 10% KOH and 0.5% podophyllotoxin for the treatment of molluscum contagiosum

Background: Molluscum contagiosum(MC) is a cutaneous viral infection caused by a member of the Poxvirus family, of  the genus Mollusci poxvirus. This benign condition is characterized by the appearance of pearly, umbilicated papules of 2-8 mm size. The lesions are asymptomatic and can affect any part of the body.Treatment of the condition is required for prevention of new lesion development and spread to other individuals through contact.Treatment consists of different destructive methods that includes curettage, electrocoagulation, clamping,and cryotherapy. These methods however are generally painful and difficult to administer in children and requires specialized skills and multiple office visits. Topical therapies (salicylic acid, tretinoin, imiquimod, or potassium hydroxide) may be self-administered with variable success rates. Since 1999,some studies have been published that satisfactorily tested the use of potassium hydroxide (KOH) in different concentrations. [1,2,3], however minor side effects were observed in roughly 30 to 80% of patients. The most common side effect was found to be pigmentary changes [4] which is often unacceptable in pigmented races.Podophyllotoxin, the active ingredient of podophyllin, a crude extract of May apple plant is an approved treatment of genital warts. This drug has been shown in some studies to be highly effective in the treatment of MC with very little side effects.[5,6]The aim of the present study is to compare the effectiveness and safety of 10% KOH and 0.5% podophyllotoxin in a number of  healthy patients with MC. 

Primary objective: to Evaluate the efficacy (disappearance of lesions) of treating MC with twice daily (for 3 days a week) application of 0.5% podophyllotoxin as compared to daily topical applications of 10%KOH.

Secondary objectives: (a)To evaluate reduction in  the number, and size of MC lesions in affected areas.(b) To evaluate the time elapsed between treatment application and cure (disappearance of the lesions). (c)To evaluate tolerance to the treatment

Methodology: The study will be an open-label, parallel group, non-inferiority clinical trial with random treatment allocation. Patients will be randomized into two parallel treatment arms. Treatment will consist of self-application of topical 10% KOH once daily or 0.5% podophyllotoxin twice daily for three consecutive days per week.

 

A total of four appointments are planned, one baseline and three follow-up visits at 2nd, 4th, and 6th weeks. Screening will be done during the baseline visit to verify that all patients fulfill the inclusion and exclusion criteria, and have signed a  written consent form, in addition to recording socio-demographic variables and a detailed clinical history. All valid/evaluable patients will be randomly assigned to either of the treatment groups.  The efficacy of and tolerance   to the treatment, as well as the appearance of new lesions, concomitant treatments and adverse effects will be evaluated in the follow-up visits. A photograph of the affected area will be taken in each visit. Data will be recorded in a pre-tested structured schedule and the findings will be analyzed at the conclusion of the study.Inclusion Criteria:   

 Inclusion criteria: patients of all ages and both sexes who are diagnosed with a MC infection (clinical diagnosis) and who/ whose parents or guardians have provided written informed consent for participation were included in the study. 

  Exclusion criteria:  Immunocompromised patient (congenital or acquired), patient who  has received other topical treatment within the last month , pregnant and lactating women and patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visit

Study site: OPD of dermatology department of Medical College Hospitals, Kolkata

Study duration: one year  (October 2015 to September 2016) 

Sample size calculation:

The calculation of the sample size takes as its primary outcome treatment efficacy the rate of complete elimination of MC at the final follow-up visit. We based our calculation on the results of the previous studies , that reported 92% efficacy for podophyllotoxin and on an average  86% efficacy for KOH. With and non-inferiority margin of 20%, to be able to detect these differences with a chi-squared test of two independent samples with a power of 80% at the 5 % significance level  a total sample size of 38 was calculated . With an estimated loss to follow-up rate of 10%, a total of 42 patients (21 in each group) will be required for our study.

 

Statistical methods

The valid or evaluable patient group is defined as those patients that fulfill all the inclusion criteria, none of the exclusion criteria, who/whose parents have provided consent for their participation and who have been assigned a treatment. The safety sample is defined as the group of valid patients who have received treatment in the study at least once, whether or not its effectiveness has been assessed.

 The intention to treat (ITT) sample is defined as the group of valid patients who have received treatment at least once and who have been assessed for its effectiveness atleast once. The per protocol (PP) sample is defined as the group of patients that make up the ITT   sample, have been assessed for efficacy and have not violated the protocol in any of the following ways: Greater than 10% missed treatments and/or Loss to follow-up by missing a scheduled visit.

 Descriptive analysis of all the variables collected will be done, expressing quantitative variables as means, medians, minimums, maximums and standard deviations (SD), and categorical variables as frequencies and percentages.

 Independent sample t-test will be used for quantitative variables (extent, number of lesions, etc.) and the chi-squared test will be used for categorical variables (cure).

In the case that the t-test cannot be used because a quantitative parameter does not fulfill the application criteria (non-normality/heteroscedasticity) the data will be transformed (logarithmic) from the original para-meter, or a non-parametric analog test (Man-Whitney) will be used.

 The time from treatment to cure will be calculated as the difference between the date of first treatment and the disappearance of lesions or the end of the study (treatment initiation). Survival tables and the Kaplan-Meier statistic will be calculated to compare cure times between the different treatment groups. In the case that associations are found between efficacy variables and baseline conditions, a Cox proportional risk model will be adjusted.Data analysis will be by ITT, per protocol and by safety sample.In all cases a p-value below 0.05 will be considered significant.Data will be analyzed using the statistical package Medcalc version 15.8

Primary and secondary endpoints/outcome measures

Efficacy will be assessed in each of the areas detected in the previous visit. If there are new areas affected, they will be evaluated at the next visit. The primary outcome will be calculated for  each of the affected areas, as an indicator variable: (There is a lesion in the area/No lesion in the area) at 6th week from baseline. Each patient will be considered cured if they have no lesions in any of the treated areas.

Secondary efficacy variables (secondary endpoints) will be calculated for each location by number of lesions,  extent of area affected and mean size of lesions.  

Efficacy of method: Ordinal scale with five categories.

Worsening (net increase in number of lesions or growth of existing ones)

No changes (no modifications to the lesion).

 Slight improvement (disappearance of upto 50% of lesions).

 Moderate improvement (disappearance of more than 50%  of lesions).

 Cure (complete disappearance of lesions)(primary end point).

 

We concluded that 10% KOH was more effective than 0.5% podophyllotoxin in the treatment of molluscum contagiosum,it is inexpensive and efficient, albeit with a few minor adverse effects like residual pigmentation and mild scarring in few.

 

 

 

 


 
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