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CTRI Number  CTRI/2013/12/004240 [Registered on: 24/12/2013] Trial Registered Retrospectively
Last Modified On: 06/12/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect and safety of the drug Acyclovir in patients of Pityriasis rosea (a widespread red and scaly lesion following infection or drug intake) 
Scientific Title of Study   A STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF ACYCLOVIR IN PITYRIASIS ROSEA: AN INVESTIGATOR-BLIND RANDOMISED CLINICAL TRIAL 
Trial Acronym  ESAPR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debabrata Bandyopadhyay 
Designation  Professor and Head 
Affiliation  Medical College, Kolkata 
Address  88 College Street, Kolkata - 73. West Bengal.

Kolkata
WEST BENGAL
700073
India 
Phone    
Fax    
Email  dr_dban@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Nilay Kanti Das 
Designation  Associate Professor 
Affiliation  Medical College, Kolkata 
Address  88 College Street, Kolkata - 73. West Bengal.

Kolkata
WEST BENGAL
700073
India 
Phone  9433394148  
Fax    
Email  drdasnilay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amrita Sil 
Designation  Assistant Professor  
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  AJC Bose Road, Kolkata - 20

Kolkata
WEST BENGAL
700020
India 
Phone  9477737091  
Fax    
Email  drsilamrita@gmail.com  
 
Source of Monetary or Material Support  
Institutional: Medical College, Kolkata 
 
Primary Sponsor  
Name  Institutional Medical College Kolkata 
Address  Medical College, 88, College Street, Kolkata - 73 
Type of Sponsor  Government medical college 
 
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 
Nilay Kanti Das  Medical College  Room no. 403, OPD Building, Department of Dermatology, 88, College Street, Kolkata - 73
Kolkata
WEST BENGAL 
9433394148

drdasnilay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee for Human Research, Medical College, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from Pityriasis rosea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acyclovir, Calamine lotion, Cetirizine   400 mg acyclovir thrice daily for a duration of initial 7 days of the 4 week treatment. Patients will be receiving calamine lotion and Cetirizine 10 mg tablet once daily for all four consecutive weeks.  
Comparator Agent  Calamine lotion, Cetirizine tablets  Patients will be receiving calamine lotion and Cetirizine 10 mg tablet once daily for all four consecutive weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a. All patients presenting with pityriasis rosea.
b. Patients giving informed written consent
 
 
ExclusionCriteria 
Details  a. Patients not willing to participate in the study
b. Pregnant or breast feeding women
c. Any history of sensitivity to acyclovir or erythromycin or cetirizine
d. Renal or hepatic impairment
e. Suspicion of having fungal infection, psoriasis, or eczema.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of symptoms (Symptom score) on a 0-10 scale  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks following randomoization 
 
Secondary Outcome  
Outcome  TimePoints 
1. Spontaneously reported adverse events
2. Adverse events elicited by the clinicians
 
1 week, 2 weeks, 3 weeks, 4 weeks following randomoization 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/07/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Pityriasis Rosea (PR) is an acute inflammatory and self-limiting skin disorder, sometimes with troublesome symptoms. It begins as a solitary thin oval scaly plaque called a herald patch, and is typically asymptomatic.  PR is common among patients visiting dermatologists. The incidence of varies from 0.39 to 4.80 per 100 dermatological patients. There are a number of studies in favour of an infectious etiology for this disorder, and now it is believed that PR is induced by some of the Human Herpes Virus members, mainly HHV7 and HHV6. The association of human herpesvirus 6 (HHV-6) and HHV-7 with pityriasis rosea suggests that systemic drugs directed against HHV may hasten recovery of patients with pityriasis rosea. To date, there are few treatments available for this disorder. Ehsani A. et al. conducted a study at a university in Tehran, Iran to compare the efficacy of high dose acyclovir on the period and signs of pityriasis rosea.  There is no such clinical trial conducted in India, yet and this is why, we intend to conduct this study in a tertiary care institution like ours.

Our objective was to evaluate the effectiveness and safety of acyclovir in the treatment of pityriasis rosea compared to standard treatment protocol with calamine lotion and cetirizine.

The institution-based observer blind randomised comparative clinical trial will be conducted in the Out Patient Department of Dermatology of Medical College and Hospital, Kolkata. All patients presenting with pityriasis rosea (as per inclusion criteria will be recruited in study). The study population will be randomized by computer generated random numbers into two parallel groups group A, B with group A receiving Tablet acyclovir 400mg three times daily along with standard care of calamine lotion and Tablet Cetirizine 10 mg at bed time, group B receiving calamine lotion and Tablet Cetirizine 10 mg once daily. Simple randomised sampling would be done with allocation ratio of 1:1. The recruitment target is of approximately 12 subjects per group. The observer will be a dermatologist unaware of the randomisation allocation of the study drugs who will be assessing the effectiveness and safety parameters at each visit and thus blinded. There will be four weekly follow-ups where the effectiveness and safety parameters will be recorded.

The primary effectiveness parameter are the assessment of symptoms (Symptom score) on a 0-10 scale which includes new lesion appearance, pruritus grade, lesion features like erythema, scaling, number of lesions. Safety parameters will be the spontaneously reported adverse events and those elicited by the clinicians.  

 

 

 

 
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