| CTRI Number |
CTRI/2024/03/064118 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effectiveness and safety of Topical clindamycin vs minocycline vs ozenoxacin in patients of Acne vulgaris |
|
Scientific Title of Study
|
A study of The efficacy and safety profile of topical Clindamycin 1% gel versus topical Minocycline 4% gel versus topical Ozenoxacin 1% cream in the treatment of Acne Vulgaris, a triple arm randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Bansal |
| Designation |
Pg Resident |
| Affiliation |
IMS and Sum Hospital |
| Address |
Department of Dermatology, Ground floor, Ims and Sum Hospital, Kalinganagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7987163597 |
| Fax |
|
| Email |
parulbansal130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaya Kumar Jena |
| Designation |
Professor |
| Affiliation |
Ims and Sum Hospital |
| Address |
Professor room, Department of Dermatology, Ground floor, IMS and SUM Hospital K8, Kalinga nagar, Khorda, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9437909933 |
| Fax |
|
| Email |
ajayajena@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Parul Bansal |
| Designation |
Pg resident |
| Affiliation |
Ims and Sum Hospital |
| Address |
Department of Dermatology, Ground floor, Ims and Sum Hospital, Kalinga nagar, Khordha, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7987163597 |
| Fax |
|
| Email |
parulbansal130@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Ims and Sum hospital, Kalinganagar, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [] |
|
|
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 Parul Bansal |
Ims and Sum Hospital |
Department of Dermatology, Ground floor, Ims and Sum Hospital, Kalinganagar, Khordha, Bhubaneswar, Odisha, 751003
Khordha
ORISSA |
7987163597
parulbansal130@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, IMS and SUM Hospital |
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 |
| Intervention |
Topical Clindamycin gel |
Clindamycin 1% gel local application twice daily for 3 months |
| Comparator Agent |
Topical Minocycline gel |
Minocycline 4% gel local application once daily at night for 3 months |
| Comparator Agent |
Topical ozenoxacin cream |
Ozenoxacin 1% cream local application twice daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Mild papulopustular Acne fairly localized inflamed and non-inflamed lesions, superficial inflammatory lesions being less than 5mm in diameter according to European evidence based S3 acne guidelines |
|
| ExclusionCriteria |
| Details |
Patients with mild comedonal acne
Patients with moderate or severe acne
Patients who have been regularly using anti acne medications since the last 30 days
Patients with acne conglobate, acne fulminans or drug-induced acne
Patients with history of hypersensitivity to clindamycin, minocycline or ozenoxacin
Patients who are unwilling or unable to comply with the study proceedings to give written, informed consent
Pregnant or lactating women
Patients with history of photosensitivity
Hormonal or endocrine or autoimmune abnormality
Topical Steroid Dependent Face
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| number of total lesion count, seperating the inflammatory and non-inflammatory lesions, evaluators global acne severity score, investigators global assessment score, patients assessment score |
every monthly for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| presence of scaling, erythema, burning, itching, stinging |
every monthly for 3 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
23/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The patients meeting the inclusion criteria shall be considered to participate in the study A detailed history including the duration of the disease, associated medical conditions to be taken. The patients are randomized and allocated to the three interventional groups One group will be given topical Clindamycin 1% gel to be applied locally twice daily The second group will be given topical Minocycline 4% gel, to be applied locally once daily The third group will be given topical Ozenoxacin 1% cream, to be applied topically twice daily Follow up is done at 4weeks, 8weeks and 12 weeks To assess the outcome, the no. of total and each type of acne lesions(non inflammatory and inflammatory) are counted, Evaluator’s global acne severity score and Investigator’s global assessment score(IGA) scores are calculated at the initial visit and at each follow up To assess the adverse effects, any reaction or peeling/desquamation, stinging, burning, redness/erythema, and itching/pruritis in lesions are duly noted Clinical images will be taken at the starting of the therapy and in each follow up to look for the improvement
|