| CTRI Number |
CTRI/2025/09/094075 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| 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 different dosing schedules of oral isotretinoin for treatment of acne in 45 participants |
|
Scientific Title of Study
|
Comparative therapeutic efficacy of
different dosage regimens of oral
isotretinoin 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 |
Dr Priya Dagar |
| Designation |
Postgraduate- Junior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Dermatology, Venereology and Leprosy
Level 5
D block
Government Medical College and Hospital
Sector 32, Chandigarh
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9915918149 |
| Fax |
|
| Email |
priyadagar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Gurvinder Pal Thami |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Dermatology,
Venereology & Leprosy
Level 5
D block
Government Medical College and Hospital,
Sector-32, Chandigarh.
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121544 |
| Fax |
|
| Email |
thamigp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Dagar |
| Designation |
Postgraduate- Junior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Dermatology, Venereology and Leprosy
Level 5
D block
Government Medical College and Hospital
sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9915918149 |
| Fax |
|
| Email |
priyadagar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital
Sector 32
Chandigarh
India
160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32
Chandigarh
India
160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Priya Dagar |
Government Medical College and Hospital Chandigarh |
Department of Dermatology Venereology and Leprosy
Chandigarh
CHANDIGARH |
9915918149
priyadagar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
Dose of 20 mg on alternate days |
Group B consisting of 15 patients shall receive the dose of 20 mg on alternate days |
| Intervention |
dose of 20mg daily |
All patients will receive oral isotretinoin in the dosage of 0.5mg/kg to a maximum of 20 mg as per allocation to the study groups for a fixed period of 12 weeks.
There will be three groups in the study.
Group A consisting of 15 patients will receive the dose of 20 mg daily |
| Comparator Agent |
The dose of 20 mg daily for a week followed by drug free period of one week |
Group C consisting of 15 patients shall receive the dose of 20 mg daily for a week followed by drug free period of one week (intermittent therapy ) |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients of acne vulgaris (Grade 2 and above) involving the face who have
not received any treatment in the past four weeks. |
|
| ExclusionCriteria |
| Details |
1. Pregnant females / females planning pregnancy within the next 9 months / breastfeedingfemales.
2. Immunosuppressed individuals.
3. Known hypersensitivity to synthetic / natural vitamin A.
4. Any systemic illness lasting more than three weeks.
5. Deranged liver function tests / lipid profile.
6. Reproductive age group females not willing to practice methods of contraception as
advised. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the percentage reduction in total acne lesion count at 12 weeks among the
three treatment groups. |
0,4,8,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the adverse effects associated with each dosage regimen of oral
isotretinoin. |
0,4,8,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the therapeutic efficacy of different dosage regimens of oral
isotretinoin in acne vulgaris. A total of 45 patients who fulfil the inclusion criteria and do not
meet any of the exclusion criteria will be randomly allocated into three groups of 15 patients
each using a random table method and prescribed different regimens of isotretinoin as per
allocation to the study groups. In each group, grading and scoring of acne will be done as per
Indian Acne Alliance guidelines. Patient will undergo liver function test and lipid profile test at
the first visit and at week 8. Patients must follow advised precautions including dual methods of
contraception for female patients of reproductive age group. UPT to be done twice at the start of
treatment and monthly thereafter till one month post completion of therapy in case of sexually
active female patients. Patients will receive treatment for 12 weeks. Follow up will be done at
four weekly intervals for which patients have to come to GMCH, Chandigarh. Assessment
including those of side effects will be done at each visit. Response to the therapy shall be
calculated on the basis of reduction in the total acne lesion count. Photographic records will be
taken for comparison at each visit.
|