| CTRI Number |
CTRI/2025/11/097975 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY TO SEE WHETHER ADDING MONTELUKAST TO ISOTRETINOIN WORKS BETTER THAN ISOTRETINOIN ALONE FOR TREATING PEOPLE WITH SEVERE ACNE |
|
Scientific Title of Study
|
A randomized, open label, prospective study to compare efficacy and safety of oral isotretinoin with adjunctive montelukast versus isotretinoin alone in patients with moderate to severe grade acne |
| 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 CHANDRAVEER SINGH |
| Designation |
PROFESSOR |
| Affiliation |
UP UNIVERSITY OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF PHARMACOLOGY UP UNIVERSITY OF MEDICAL SCIENCES
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9927791470 |
| Fax |
|
| Email |
CVSINGH.SINGH@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIL CHOUDHARY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
UP UNIVERSITY OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF PHARMACOLOGY UP UNIVERSITY OF MEDICAL SCIENCES ETAWAH UTTAR PRADESH INDIA 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9828490444 |
| Fax |
|
| Email |
sunilchoudhary.theflair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHANDRAVEER SINGH |
| Designation |
PROFESSOR |
| Affiliation |
UP UNIVERSITY OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF PHARMACOLOGY UP UNIVERSITY OF MEDICAL SCIENCES
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9927791470 |
| Fax |
|
| Email |
CVSINGH.SINGH@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| UP UNIVERSITY OF MEDICAL SCIENCES UTTAR PRADESH INDIA 206130 |
|
|
Primary Sponsor
|
| Name |
UP UNIVERSITY OF MEDICAL SCIENCES |
| Address |
SAIFAI ETAWAH UTTAR PRADESH INDIA 206130 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SUNIL CHOUDHARY |
ROOM NO 17 DEPARTMENT OF DERMATOLOGY UPUMS HOSPITAL |
UP UNIVERSITY OF MEDICAL SCIENCES SAIFAI ETAWAH UTTAR PRADESH
Etawah
UTTAR PRADESH |
09828490444
sunilchoudhary.theflair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
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 |
GROUP 1 - ORAL ISOTRETINOIN WITH ORAL MONTELUKAST |
GROUP 1 WHICH IS TRAIL GROUP WILL RECEIVE ORAL MONTELUKAST ALONG WITH STANDARD TREATMENT FOR MODERATE TO SEVERE GRADE ACNE |
| Comparator Agent |
GROUP 2 ORAL ISOTRETINOIN ALONE |
GROUP 2 WHICH IS CONTROL GROUP WILL RECEIVE ONLY STANDARD TREATMENT OF ORAL ISOTRETINON |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH MODERATE TO SEVERE GRADE ACNE VISITING OPD FOR TREATMENT, ALSO WHO HAD NOT TAKEN ANY OTHER SYSTEMIC TREATMENT OR TOPICAL TREATMENT IN PAST 4 WEEKS |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH SYSTEMIC DISEASES, KIDNEY OR LIVER DYSFUNCTION, NEWLY MARRIED FEMALES, PREGNANCY OR LACTATING FEMALES, WHHO WERE RELUCTANT TO COME FOR REGULAR FOLLOW UP, POSITIVE HISTORY OF ALLERGY TO THESE DRUGS, SMOKERS AND ALCOHOLICS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFICACY OF ISOTRETINOIN WITH ADJUNCTIVE MONTELUKAST VERSUS ISOTRETINOIN ALONE IN MODERATE TO SEVERE ACNE VULGARIS |
BASELINE, 4 WEEK, 8 WEEK, 12 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE SAFETY PROFILES OF ISOTRETINOIN WITH ADJUNCTIVE MONTELUKAST VERSUS ISOTRETINOIN ALONE IN MODERATE TO SEVERE ACNE VULGARIS |
BASELINE, 4 WEEK, 8 WEEK, 12 WEEK |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
05/12/2025 |
| 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 will be conducted in the Department of Pharmacology in collaboration with Department of Dermatology, Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. The study will be completed in 12 weeks. Consent will be taken from each patient for baseline patient information, including a colour photo of the lesion area, during the initial visit. There will be a physician assessment on initial visit that includes grading of lesions based on two scales (Total Lesion Count and Global Acne Grade Scale) and blood test (CBC, LFT), random blood sugar. Then, using the odd even technique, they will be randomly allocated to either group, A or B for a duration of 12 weeks.
Group A will receive isotretinoin 0.5 mg/kg/day along with montelukast 10 mg once daily. Group B will receive isotretinoin 0.5 mg/kg/day alone. When the patient steps out the house, it will also be advised that they use lipid-free sunscreen with an SPF above 30. The patient will be checked on every four weeks. The patient will be monitored to see whether the symptoms may return after ceasing medication after the 12-week mark, which will include a review of the Isotretinoin vs Isotretinoin with Montelukast treatment groups. |