| 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
|
|
|
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
|
|
|
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. |