Efficacy Of Oral Isotretinoin With Levocetirizine Vs Oral Isotretinoin Monotherapy In Acne Vulgaris: A Randomised Controlled Trial

Efficacy Of Oral Isotretinoin With Levocetirizine Vs Oral Isotretinoin Monotherapy In Acne Vulgaris: A Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098348

Enrollment

Registered

2025-12-03

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: Isotretinoin plus leveocetrizine: Isotretinoin 1 tab once daily after food plus levocetrizine 1 tab once daily bedore food at night for 12 weeks Control Intervention1: Isotretinoin: 1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged more than 18 years with a diagnosis of moderate to severe acne vulgaris 2. Patients available for regular follow-up visits during the study period

Exclusion criteria

Exclusion criteria: 1.Patients with a known allergy or intolerance to isotretinoin. 2.Patients with deranged LFT and Lipid Profile. 3.Patients planning for pregnancy, Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
To determine whether Isotretinoin with levocetirizine is more effective than isotretinoin alone for treating acne vulgaris. Timepoint: 12 weeks	—

Secondary

Measure	Time frame
To assess the impact of combination therapy on a patient s overall quality of lifeTimepoint: 12 weeeks	—

Countries

India

Contacts

Public ContactDr Paridhi vaidh

kalinga institute of medical science

drparidhivaidh@gmail.com9831055448

Outcome results

None listed

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