| CTRI Number |
CTRI/2024/02/062423 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of safety and effectiveness in between topical Adapalene plus clindamycin and topical Adapalene plus benzoyl peroxide for treatment of inflammatory Acne vulgaris |
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Scientific Title of Study
|
Efficacy and Safety of Topical Adapalene(0.1%W/W) & CLINDAMYCIN(1%W/W) versus Topical Adapalene(0.1%W/W) & Benzoyl peroxide(2.5%W/W) in Inflammatory Acne Vulgaris: A Comparative study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUMIK BISWAS |
| Designation |
1st year post graduate trainee student |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
4th floor Academic building, Department of Pharmacology, NilRatan Sircar Medical College & Hospital, 138 AJC Bose Road, Kolkata-700014
4th floor Academic building, Department of Pharmacology, NilRatan Sircar Medical College & Hospital, 138 AJC Bose Road, Kolkata-700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
8583862721 |
| Fax |
|
| Email |
Sanu45biswas22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARIJIT GHOSH |
| Designation |
Professor |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
4th floor, Academic building, department of Pharmacology, Nilratan Sircar Medical College & Hospital, 138 AJC Bose Road, Kolkata-700014
4th floor, Academic building, department of Pharmacology, Nilratan Sircar Medical College & Hospital, 138 AJC Bose Road, Kolkata-700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9874727137 |
| Fax |
|
| Email |
drarijitghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SOUMIK BISWAS |
| Designation |
1st year post graduate trainee student |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
4th floor Academic building, Department of Pharmacology, NilRatan Sircar Medical College & Hospital, 138 AJC Bose Road, Kolkata-700014
4th floor Academic building, Department of Pharmacology, NilRatan Sircar Medical College & Hospital, 138 AJC Bose Road, KOLKATA-700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
8583862721 |
| Fax |
|
| Email |
Sanu45biswas22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nilratan Sircar Medical College & Hospital
138, AJC Bose Road, KOLKATA-700014 |
|
|
Primary Sponsor
|
| Name |
DR SOUMIK BISWAS |
| Address |
4th floor,Academic building, Department of Pharmacology, Nilratan Sircar Medical College
138 AJC Bose Road
Kolkata-700014 |
| Type of Sponsor |
Other [NA] |
|
|
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 SOUMIK BISWAS |
Nilratan Sircar Medical College |
4thfloor, Academic building, Department of Pharmacology, room no 3,NilRatan Sircar Medical College, 138 AJC Bose Road
KOLKATA 700014
Kolkata
WEST BENGAL |
8583862721
Sanu45biswas22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRSMC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
apparently healthy human volunteers of both sex who had given consent |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adapalene with Benzoyl peroxide |
Fixed dose combination of topical Adapalene(0.1% w/w) and Benzoyl peroxide(2.5%w/w) |
| Comparator Agent |
Adapalene with Clindamycin |
Fixed dose combination of topical Adapalene(0.1%w/w) and Clindamycin(1%w/w) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18 years and below 30 years of age of either sex |
|
| ExclusionCriteria |
| Details |
Patients of 30 years and above of age of either sex |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| changes in Inflammatory lesion count, Investigator global assessment score, Cardiff acne disability index from baseline will be assessed to determine the outcome at 4th, 8th and 12th week |
changes in Inflammatory lesion count, Investigator global assessment score, Cardiff acne disability index from baseline will be assessed to determine the outcome at 4th, 8th and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of inflammatory acne vulgaris & medication adherence score will be assessed at baseline to determine the outcome at 4th, 8th & 12th week |
Severity of inflammatory acne vulgaris & medication adherence score will be assessed at baseline to determine the outcome at 4th, 8th & 12th week |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
16/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acne Vulgaris, chronic inflammatory condition, is characterized by open and closed comedones, erythematous papules and pustules. In current treatment guidelines, topical retinoids like Adapalene are commonly prescribed along with antimicrobial such as Clindamycin. This combination has proven to reduce acne lesions faster, prevent antimicrobial resistance. On the other hand, synergistic effect of Benzoyl peroxide enhances more penetration of Adapalene in the skin, and prevents the growth of Propionibacterium acne when used together. There is no such published study in eastern zone of India. Hence a study has been planned to compare the efficacy and safety of combination of topical Adapalene and Clindamycin gel with combination of topical Adapalene and Benzoyl Peroxide gel for the treatment of inflammatory Acne Vulgaris |