| CTRI Number |
CTRI/2010/091/000445 [Registered on: 10/05/2010] |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in patients with with recurrent cold sores. Clinical trial is to study efficacy, safety and tolerability of Acyclovir + hydrocortisone Cream in comparison toAcyclovir cream (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double blind, Multicentric,
Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Acyclovir 5% w/w + hydrocortisone 1% w/w Cream vs. Acyclovir 5% w/w cream in patients with recurrent cold sores.
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| APL / CT / 09 / 033 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
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| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
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|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejas Shah |
Aadit Hospital |
Farhin Party Plot,,Custom Road, Chala, Vapi,
Gujarat 396191
Valsad
GUJARAT |
09824155909
aadithospital@yahoo.com |
| Dr Deepak Masalekar |
Abhay Skin Care Clinic |
Angooribagh,Mondha Road,
Aurangabad
BIHAR |
09422703149
deepakmaslekar@yahoo.in |
| Dr Suhas Rao |
Shree Venkatesha Hospital and Polyclinic |
A-wing, 1st floor, Bably Apartment,Station Road, Nallasopara (W),
Thane
MAHARASHTRA |
09821881087
drcrholambe@gmail.com |
|
Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Jagruti - Independent Ethics Committee |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400050, |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400050, |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B108||Other human herpesvirus infection, Recurrent cold sores, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Acyclovir 5% w/w + hydrocortisone 1% w/w Cream |
5 times daily at 4 hours interval for maximum period of 7 days or till the disease gets cured |
| Comparator Agent |
Acyclovir 5% w/w cream |
5 times daily at 4 hours interval for maximum period of 7 days or till the disease gets cured |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical diagnosis of Herpes Labialis confirmed by microscopic evaluation.
2. Clinical history of herpes simplex labialis with at least two recurrences during the past 12 months. The most recent previous episode must have healed at least 7 days before screening.
3. Less than 12 hours after prodrome initiation (i.e. local erythema w/o blistering, tingling and or burning sensation, soreness).
4. Written informed consent by patient to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1. Patients < 18 & > 60 years
2. History of hypersensitivity to the study drug or similar class of drug
3. Significant history or presence of gastrointestinal, liver or kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications
4. Pregnant or nursing females
5. No intra-oral lesions or lesions above the nostrils and below the chin
6. No topical steroid use and no systemic antiviral current treatments within 7 days before the study
7. No known allergies to topical cosmetics
8. No use cosmetics on or around the mouth during the treatment period
9. No concomitant use of systemic corticosteroids or other drugs known to induce immune stimulation or immune suppression.
10. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study
11. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
|
|
Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Combination of itching, burning, tingling and a dry feeling at the site of the future cold sore |
Day 0, Day 3, Day 5 and Day 7. |
|
Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Safety and tolerability |
Day 0, Day 3, Day 5 and Day 7. |
| global assessment |
Day 7 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
14/05/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
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This study is s Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Acyclovir 5% w/w + hydrocortisone 1% w/w Cream vs. Acyclovir 5% w/w cream in 100 patients with recurrent cold sores. The date of first enrollment will be 14 May 2010.
The primary outcome measures will be assessed by TZANCK test, Microscopic Examination of viral culture, Combination of itching, burning, tingling and a dry feeling at the site of the future cold sore, Swelling at the site of future cold sore, Lesions near the mouth, on the lips, tongue, gums, and the nose, blisters, Pain, Small, red pimple like bumps and Ulcer-like sores on day 0, 3, 5 and 7. The secondary outcome measures will be Safety and tolerability and global assessment. |