| CTRI Number |
CTRI/2018/05/013916 [Registered on: 16/05/2018] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [INTERVENTIONAL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare efficacy and tolerability of Oral Azithromycin versus Oral Doxycycline with topical Clindamycin in subjects with moderate to severe Acne Vulgaris |
|
Scientific Title of Study
|
A prospective, randomised, open label, parallel group, comparative study of efficacy and tolerability of Oral Azithromycin versus Oral Doxycycline with topical Clindamycin in subjects with grade 2 and grade 3 Acne Vulgaris |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr APOORVA |
| Designation |
MBBS ,Post Graduate in M.D Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE,affiliated under RGUHS |
| Address |
Department of Pharmacology
Kempegowda Institute of Medical sciences
Banashankari second stage
Bangalore
KARNATAKA
560070
India |
| Phone |
9902333326 |
| Fax |
|
| Email |
apoorvaprabhu89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K GIRISH |
| Designation |
Professor and Head of the Department |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE affiliated under RGUHS |
| Address |
Department of Pharmacology,
Kempegowda Institute of Medical Sciences,Banashankari second stage
Bangalore
KARNATAKA
560070
India |
| Phone |
9980911060 |
| Fax |
|
| Email |
drgirish_k@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr APOORVA |
| Designation |
MBBS ,Post Graduate M.D Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,BANGALORE affiliated under RGUHS |
| Address |
Department of Pharmacology,
Kempegowda Institute of Medical Sciences,Banashankari second stage
Bangalore
KARNATAKA
560070
India |
| Phone |
9902333326 |
| Fax |
|
| Email |
apoorvaprabhu89@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Apoorva |
| Address |
Department of Pharmacology
Kempegowda Institute of Medical Sciences,Banashankari second stage,Bangalore
|
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Apoorva |
KIMS Hospital |
Out Patient Department,Room no-12
Department of Dermatology,B Block,Ground Floor
Bangalore
KARNATAKA |
9902333326
apoorvaprabhu89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ACNE VULGARIS GRADE 2 AND GRADE 3, (1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab Azithromycin and topical Clindamycin |
Tab Azithromycin 500mg OD 3 times a week for 8 weeks and topical Clindamycin 1% every night for 8 weeks |
| Comparator Agent |
Tab Doxycycline and topical Clindamycin |
Tab Doxycycline 100mg OD daily for 8 weeks and topical Clindamycin 1% every night for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Willingness to give written informed consent and availability for regular followup.
Subjects with Acne Vulgaris of grade 2 and 3 as per the investigators global assessment scale.
Subjects must be willing to refrain from using all other topical Acne medications or antibiotics during the 8 week treatment period. |
|
| ExclusionCriteria |
| Details |
Subjects with severe acne, nodulocystic lesions, acne conglobate, acne fulminans, acne rosacea, secondary(drug induced) acne.ion ingestion.
Subjects with a history of hypersensitivity or allergy to any study medication ingredients.
Subjects who have participated in any investigational drug study within 30 days prior to baseline will be excluded from participation.
Female subjects who are pregnant,lactating or planning to become pregnant during study participation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy and tolerability of oral Azithromycin and oral Doxycycline in subjects with grade 2 and 3 acne vulgaris |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life will be assessed using DLQI score |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/05/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Ronald Mark ; Acne, Rosacea, Similar disorder ;Roxburg’s common skin disease;
17 th edition ;Hodder Arnold ,2003,p149-161
2.Sacchidanand; Savitha A S; Shilpa K editor, Acne vulgaris; Snapshots in Dermatology,1st edition, JAYPEE brothers,2013,page7-11
3.John S. Strauss, MD, Chair et al;Guidelines of care for acnevulgaris management;
JAMACADDERMATOL APRIL 2007; p651-663
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized by comedones, papules, pustules, nodules and often scars.Acne is commonly encountered in adolescents and young adults.Even though acne vulgaris donot cause any mortality but often there is significant physical and psychological morbidity like permanent scarring,poor self image,depression and anxiety as it commonly effects the face,back and chest.Therefore, early and effective treatment of acne lesions is vital to prevent facial scars that lead to cosmetic and psychological impact on the subjects.Inspite of the availability of various therapies,standard guidelines and recommendations, the outcome of these therapies are still unsatisfactory with regard to efficacy,tolerability,safety,adverse effects and bacterial resistance.There are a few studies comparing efficacy and tolerability of pulsed oral azithromycin and doxycycline with topical clindamycin in Indian population and hence the present study is taken. |