Efficacy and safety of ultra low dose vs low dose isotretinoin in moderate to severe acne

Efficacy and safety of ultralow dose isotretinoin versus low dose isotretinoin for the management of moderate to severe acne vulgaris: a single blinded randomized controlled trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076193

Enrollment

128

Registered

2024-11-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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 A- Ultra low dose oral isotretinoin : 0.3mg/kg of ultra low dose oral isotretinoin will be given to patients randomised into group A and dose will be decreased or stopped if comp

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 14 years Patients with moderate to severe acne (GAGSscore greater than 19)

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Leucopenia with leucocyte count less than 4000 per microlitre Liver enzymes (ALT/AST) above the upper limit of reference range Moderate to severe cholesterol and triglycerides elevation Deranged renal function test Known case of Hepatitis B or hepatitis C. Concomitant use of other hepatotoxic drugs Any preexisting liver disease Sexually active females of reproductive age group who are not willing to use contraception as required. Patients on any other immunosuppressive, immunomodulatory drugs or on drugs that has significant interaction with isotretinoin Known case of psychiatric disease Known hypersensitivity reaction to isotretinoin. Patients with baseline transaminitis (ALT OR AST greater than 50) Dyslipidemia Patient on any systemic therapy for acne in last 4 weeks Patients with clinical signs of hirsutism

Design outcomes

Primary

Measure	Time frame
to observe Ultra-low dose of isotretinoin is non-inferior to low dose isotretinoin on clearance of acne among the patients with moderate to severe acne vulgaris.Timepoint: at baseline,3rd month,6th month and at the end of 1st year	—

Secondary

Measure	Time frame
To compare the adverse effect profile among the patients with moderate to severe acne treated with ultra low dose and low dose isotretinoin.Timepoint: at baseline,3rd month,6th month and at the end of 1st year	—

Countries

India

Contacts

Public ContactDr Rashmi Kumari

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),Pondicherry

rashmi.sreerag@gmail.com9489692199

Outcome results

None listed

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