A STUDY TO SEE WHETHER ADDING MONTELUKAST TO ISOTRETINOIN WORKS BETTER THAN ISOTRETINOIN ALONE FOR TREATING PEOPLE WITH SEVERE ACNE

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097975

Enrollment

160

Registered

2025-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: 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 Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
TO COMPARE THE EFFICACY OF ISOTRETINOIN WITH ADJUNCTIVE MONTELUKAST VERSUS ISOTRETINOIN ALONE IN MODERATE TO SEVERE ACNE VULGARISTimepoint: BASELINE, 4 WEEK, 8 WEEK, 12 WEEK	—

Secondary

Measure	Time frame
TO COMPARE THE SAFETY PROFILES OF ISOTRETINOIN WITH ADJUNCTIVE MONTELUKAST VERSUS ISOTRETINOIN ALONE IN MODERATE TO SEVERE ACNE VULGARISTimepoint: BASELINE, 4 WEEK, 8 WEEK, 12 WEEK	—

Countries

India

Contacts

Public ContactDR CHANDRAVEER SINGH

UP UNIVERSITY OF MEDICAL SCIENCES

sunilchoudhary.theflair@gmail.com9828490444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026