| CTRI Number |
CTRI/2013/07/003856 [Registered on: 31/07/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/07/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bacteriology of pustular acne and evaluation of the efficacy of systemic azithromycin and minocycline in pustular acne |
|
Scientific Title of Study
|
Bacteriology of pustular acne and evaluation of the efficacy of systemic azithromycin and minocycline in pustular acne |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR REEJA MARIAM GEORGE |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY,FATHER MULLER MEDICAL COLLEGE
HOSPITAL, KANKANADY,
MANGALORE - 575 002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
GREEJA@YAHOO.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMESH BHAT M |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY, FATHER MULLER MEDICAL COLLEGE
HOSPITAL, KANKANADY,
MANGALORE - 575 002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
RAMESHDERMA@YAHOO.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMESH BHAT M |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY, FATHER MULLER MEDICAL COLLEGE
HOSPITAL, KANKANADY,
MANGALORE - 575 002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
RAMESHDERMA@YAHOO.COM |
|
|
Source of Monetary or Material Support
|
| FATHER MULLER MEDICAL
COLLEGE HOSPITAL,
KANKANADY, MANGALORE – 2
|
|
|
Primary Sponsor
|
| Name |
DR REEJA MARIAM GEORGE |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY,FATHER MULLER MEDICAL COLLEGE
HOSPITAL, KANKANADY,
MANGALORE - 575 002
|
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DR REEJA MARIAM GEORGE |
SKIN OPD 35, FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY.
FATHER MULLER MEDICAL
COLLEGE HOSPITAL,
KANKANADY, MANGALORE – 2
Dakshina Kannada
KARNATAKA |
8197104363
GREEJA@YAHOO.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, FATHER MULLER MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ACNE VULGARIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TABLET AZITHROMYCIN |
ORAL 500MG ONCE DAILY FOR THREE DAYS PER WEEK FOR 6 WEEKS |
| Comparator Agent |
TABLET MINOCYCLINE |
ORAL 100MG DAILY FOR 6 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 14 years and of both sexes.
2. Patients having pustular acne vulgaris.
3. Patients willing to undergo treatment and to come for follow up.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 14 years.
2. Patients having other presentations of acne vulgaris.
3. Pregnant women and women who intend to become pregnant during the course of the treatment.
4. Presence of any known renal or hepatic disease.
5. Patients not willing for necessary investigations
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| identify the aerobic and anaerobic bacteria in pustular acne |
4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of oral azithromycin and minocycline in pustular acne |
4 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2011 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study is to identify the various aerobic and anaerobic bacteria in pustular acne and to evaluate the efficacy of oral Azithromycin and Minocycline in pustular acne. Pus samples were taken from 40 patients with pustular acne and were subjected to microbiological and biochemical tests to determine the bacteriology. The patients were randomly allocated one of the two regimens of treatment either azithromycin or minocycline. Repeat samples were taken after 6 weeks to determine the clinical and bacteriological efficacy of the treatment given, |