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Comparison of minocycline extended release tablet versus minocycline tablet in patients with facial pimples

Comparison of the efficacy, safety and cost effectiveness of minocycline hydrochloride extended release versus minocycline in moderate to severe non-nodular facial acne vulgaris: A Randomised , parallel, open label, prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022267
Enrollment
72
Registered
2019-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Tablet Minocycline: 50mg/ 100mg BD for 8 weeks. Minocycline is an oral antibiotic widely used in moderate-to-severe acne. Minocycline has anti-inflammatory properties, activity against

Sponsors

Government Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects with inflammatory, non nodular moderate to severe facial acne vulgaris 2.Subjects between 12-18 years of age, written assent will be taken. 3.Subjects of either gender. 4.Subjects willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with more than 2 nodules or cysts on the face, 2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study. 4 Subjects with known or suspected allergy to one of the investigational products. 5. Subjects with history of liver & kidney disorder. 6. Subjects on anticoagulants, antacids, iron tablets.. 7. Subjects with history of autoimmune disorder.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of Extended release minocycline versus minocycyline in moderate to severe non-nodular facial acne vulgaris. Timepoint: efficacy assessment will be done at 4th week and then at 8th week

Secondary

MeasureTime frame
1. To assess the safety of extended release minocycline and minocycline in moderate to severe non nodular facial acne vulgaris. 2.To assess the cost effectiveness of extended release minocycline and minocycline in moderate to severe non nodular facial acne vulgaris.Timepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Jayesh Mukhi

Government Medical College, Nagpur

gndakhle@rediffmail.com9850539353

Outcome results

None listed

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