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Usefulness of Timolol in a condition of vascular overgrowth of tissue

Effectiveness and safety of 0.5% Timolol aqueous solution in treatment of pyogenic granuloma - multicentic, randomized, double-blind, placebo controlled pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018581
Enrollment
40
Registered
2019-04-12
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: L980- Pyogenic granuloma

Interventions

Intervention1: Timolol 0.5% long-acting aqueous solution: Topical application of 2 drops over the lesion twice daily for 6 weeks Control Intervention1: Glycerine solution: Topical application of 2 dro

Sponsors

Indian Association of Dermatologists Venereologists and Leprologists Research grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Clinically diagnosed cases of pyogenic granuloma over skin ii. Age 2 years to 65 years iii. Patients consenting/ assenting to participate in the trial and come for follow â?? up visits iv. Duration of skin lesion not more than 8 weeks

Exclusion criteria

Exclusion criteria: i. Age less than 2 years or more than 65 years ii. Mucosal pyogenic granuloma iii. Pregnant or lactating patients iv. Systemic comorbidities like cardiac problems (sinus bradycardia, 2nd or 3rd degree AV block, overt cardiac failure, cardiogenic shock), bronchial asthma, COPD, persistent hypoglycemia v. Patient on systemic beta-blockers, calcium channel blockers, quinidine, which have a significant interaction with topical timolol. vi. Use of any other treatment modality previously

Design outcomes

Primary

MeasureTime frame
Change in size of the lesion in millimetersTimepoint: 0, 2, 4, 6 weeks

Secondary

MeasureTime frame
Global assessment of improvement based on photographic evaluation â?? into 4 grades Grade 1- 75% improvement, Grade 2 â?? 50-75% improvement, Grade 3- 25-50% improvement and Grade 4 - 25% improvementTimepoint: 0, 2, 4, 6 weeks;Improvement in color will be expressed subjectively in terms of four grades: 1, 2, 3 and 4 where Grade 1 is complete improvement and return to skin color, while Grade 4 is â??no changeâ?? , with the lesion remaining redTimepoint: Baseline at 0 weeks and at 6 weeks;Patientâ??s global assessment regarding the improvement with the treatment (or parentâ??s in the case of patients less than 18 years) will be done on a five point scale â?? Grade 1 â?? Excellent, Grade 2 - Very good, Grade 3 - Good, Grade 4 â?? Poor, 5 - No changeTimepoint: 0, 2, 4, 6 weeks;Physiciansâ??s global assessment regarding the improvement with the treatment will be done on a five point scale â?? Grade 1 â?? Excellent, Grade 2 - Very good, Grade 3 - Good, Grade 4 â?? Poor, 5 - No changeTimepoint: 0, 2, 4, 6 weeks

Countries

India

Contacts

Public ContactAmrita Sil

Bankura Sammilani Medical College

drdasnilay@gmail.com9433394148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026