| CTRI Number |
CTRI/2024/07/071616 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing efficacy of different topical antibiotics benzoyl peroxide vs clindamycin vs minocycline) in management of grade 2 acne |
|
Scientific Title of Study
|
A prospective comparative randomized open label tri arm study on efficacy and tolerability of topical 2.5 percent benzoyl peroxide gel vs 1 percent clindamycin gel vs 4 percent minocycline gelin patient with acne grade II & III |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsana Naikwadi |
| Designation |
Junior Resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical College Dhule |
| Address |
Department of Dermatology, Venerology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat Bypass, DHULE
.
Dhule
MAHARASHTRA
424001
India |
| Phone |
08788235836 |
| Fax |
|
| Email |
jyotsananaikwadi7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Sajgane |
| Designation |
Associate Professor |
| Affiliation |
Shri Bhausaheb Hire Government Medical College Dhule |
| Address |
Department of Dermatology, Venerology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat Bypass, Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
8879376867 |
| Fax |
|
| Email |
avisajgane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotsana Naikwadi |
| Designation |
Junior Resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical College Dhule |
| Address |
Department of Dermatology, Venerology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat Bypass, Dhule
.
Dhule
MAHARASHTRA
424001
India |
| Phone |
08788235836 |
| Fax |
|
| Email |
jyotsananaikwadi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule-424001 |
|
|
Primary Sponsor
|
| Name |
Jyotsana Naikwadi |
| Address |
Department of Dermatology, Venerology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat Bypass, Dhule |
| 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 Jyotsana Naikwadi |
Shri Bhausaheb Hire Government Medical College |
Department of Dermatology, Venerology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat Bypass, Dhule-424001
Dhule
MAHARASHTRA |
08788235836
jyotsananaikwadi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Bhausaheb Hire Government Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical Benzoyl Peroxide |
Topical Benzoyl Peroxide 2.5 percent gel once daily application over lesion for 12 weeks. |
| Comparator Agent |
Topical Clindamycin |
Topical clindamycin 1 percent gel once daily local application over lesion for 12 weeks. |
| Intervention |
Topical Minocycline |
Topical minocycline 4 percent gel once daily application over lesion for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients diagnosed with acne vulgaris grade II & III |
|
| ExclusionCriteria |
| Details |
Patient unwilling to give consent to be part of trial.
Pregnant, lactating female and patients planning pregnancy during trial period.
Patient with nodulocystic lesion, acne conglobata, acne fulminans, secondary acne, acne excoriata (e.g. chloracne, drug induced acne) or any other acne requiring systemic treatment.
People suffering from photosensitivity disorders.
Patient who has abnormal baseline investigations. Clinically significant hepatic impairement.
History of DRESS syndrome, serum sickness, vasculitis.
History of hypersensitivity to benzoyl peroxide, clindamycin, minocycline. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compar efficacy of therapy with respect to decrease in number of lesions |
Calculation of Global Acne Grading score.
Assessment of clinical photographs by blinded physician by percentage response scale.
Patient satisfaction measured according to 5 point liker scale.
Measured at baseline, 4 week, 8 weeks, 12 weeks and 3 months post treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analyse the safety & tolerability of different antibiotics benzoyl peroxide vs clindamycin vs minocycline with respect to adverse effect related to therapy |
Compared at baseline,during course of therapy at 4 week, 8week, 12week & end of post treatment follow up period I.e.after 3 month. |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
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 3 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acne is common cutaneous, inflammatory disease of pilosebaceous unit which runs chronic course. Acne can be psychologically devastating, causing psychological stress and embarrassment. Various treatment options include topical and oral medications, procedures. This randomized, prospective study aim to compare efficacy and safety of topical antibiotics in treatment of acne. Study will be conducted in tertiary care set up. Patients enrolled will be divided into 3 groups. Group A will receive benzoyl peroxide gel. Group B will recieve clindamycin gel. Group C will receive minocycline gel. |