Comparison of ozenoxacin 2% lotion and clindamycin 1% lotion in truncal acne

Effectiveness , safety and tolerability of ozenoxacin 2% lotion vs clindamycin 1% lotion in mild to moderate truncal acne : an open label randomized controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080133

Enrollment

Registered

2025-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: Ozenoxacin 2% lotion and Adapalene 0.1% gel: Twice daily and once daily respectively, for 12 weeks Route of administration : topical Control Intervention1: CLindamycin 1% lotion and Ada

Eligibility

Inclusion criteria

Inclusion criteria: 1. Untreated male and female patient between 15-35 years with mild to moderate truncal acne vulgaris 2. History of less than 3 months

Exclusion criteria

Exclusion criteria: 1. Severe acne vulgaris with nodulocystic lesions, acne conglobata, acne fulminans 2. Unwilling patient 3. Unrealistic expectations 4. Unreliable patient who could not comply with direction for treatment and/ or unable to understand or give written informed consent 5. Pregnant or lactating women 6. Patients on medication which may give rise to acneiform eruption like glucocorticoids, phenytoin, lithium, isoniazid, high dose vitamin B complex, halogenated compounds, cyclosporine, EGFR inhibitors and BRAF inhibitors etc 7. Immunosuppressed patients or patients on other immunosuppressive medication in addition to those mentioned in point no. 6. 8. History of hypersensitivity to proposed study medication or related drugs in same pharmacological group 9. History of systemic or topical treatment for acne vulgaris within last 1 month 10. Patient on medication with potential for interaction with proposed study medication

Design outcomes

Primary

Measure	Time frame
It shall be defined by reduction in number of both inflammatory and non inflammatory lesions as well as VAS and IGA scoring changes in each follow up visit ( 4 weeks, 8 weeks and 12 weeks) until these scores reach 0 or until 12 weeks whichever is earlier.Timepoint: 0,4,8, 12 weeks	—

Secondary

Measure	Time frame
Reduction in VAS scoreTimepoint: 0,4,8,12;Reduction in IGA scoreTimepoint: 0,4,8,12 weeks	—

Countries

India

Contacts

Public ContactAnupam Das

Department of Dermatology, KPC Medical College and Hospital Kolkata

anupamdasdr@gmail.com9674852138

Outcome results

None listed

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