| CTRI Number |
CTRI/2024/10/075553 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between topical and oral minocycline in acne vulgaris |
|
Scientific Title of Study
|
Comparative efficacy and safety of topical and oral minocycline in acne vulgaris |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Chander |
| Designation |
Post graduate junior resident |
| Affiliation |
Govt Medical College and Hospital Chandigarh |
| Address |
Dermatology department D block fifth floor Government Medical College and Hospital 32 sector Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9530894510 |
| Fax |
|
| Email |
monikachander5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasleen Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Govt Medical College and Hospital Chandigarh |
| Address |
Dermatology department D block fifth floor Government Medical College and Hospital sector 32 Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8360788396 |
| Fax |
|
| Email |
jasleenksandhu21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasleen Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Govt Medical College and Hospital Chandigarh |
| Address |
Dermatology department fifth Floor Block D Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8360788396 |
| Fax |
|
| Email |
jasleenksandhu21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dermatology department fifth floor D block Government Medical College and Hospital sector 32 Chandigarh pincode 160047 India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| 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 Monika Chander |
Government Medical College and Hospital Chandigarh |
Dermatology department fifth floor D block Government Medical College and Hospital sector 32 chandigarh
Chandigarh
CHANDIGARH |
9530894510
monikachander5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
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 |
Oral Minocycline extended release tablets |
In group B Thirty one patients shall receive oral minocycline extended release tablets 45 mg will be given for those weighing less than 50 kg and 65 mg will be given to
those weighing more than 50kg.Those with weight more than 85kg will be given minocycline
100 mg extended release tablet for total duration of six weeks |
| Intervention |
Topical Minocycline Gel 4% |
In Group A Thirty one patients shall receive the topical minocycline gel 4% once daily at bed time for total duration of six weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. All consecutive patients of acne vulgaris GRADE I AND GRADE II with inflammatory lesions with
four weeks of non- treatment.
2. Patients between 18 to 50 years. |
|
| ExclusionCriteria |
| Details |
1. Pregnant females
breastfeeding females
females who are planning to get pregnant.
2. Known hypersensitivity to minocycline.
3. Any severe systemic illness.
4. Patient already on treatment from last four weeks
5. Grade III acne vulgaris |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in the numbers of inflammatory lesions total number of inflammatory lesions
will be counted at baseline and at each visit and reduction in these will be calculated by the
formula number of baseline new inflammatory lesions present number of baseline
inflammatory lesions
2.Adverse events patients will be administered adverse effects check list to assess for safety.
|
Total duration of treatment 6 weeks follow up will be done every 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in non-inflammatory lesions
2. Patient self-assessment patients will assess the improvement in acne on a scale of 0 4
|
Total duration of treatment 6 weeks follow up will be done every 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
25/10/2024 |
| 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 Applicable |
| 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
|
It is an open label
randomized clinical study in which efficacy and safety of topical
minocycline gel 4% will be compared with oral minocycline extended release
tablets over a period of six weeks with follow up at every two weeks. |