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Usefulness and safety Of Cryotherapy versus Bleomycin injection in the treatment of localised keloids.

Evaluation of Efficacy, Tolerability and safety Of Cryotherapy versus Intralesional Bleomycin injection in the treatment of localised keloids: An institution based open labelled randomised controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027352
Enrollment
51
Registered
2020-08-24
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: L910- Hypertrophic scar

Interventions

Intervention1: Cryotherapy: Dose: A single freeze and thaw cycle of 30 seconds using open spray technique. Route of administration: Liquid nitrogen based cryotherapy will be applied on keloids topical

Sponsors

Bankura Sammilani Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age more than 18 yrs. to 80 yrs. 2 Previously not treated keloid 3 Localised keloid 4 Informed consent obtained 5 Willing for once monthly treatment with spray cryotherapy or intralesional bleomycin injection.

Exclusion criteria

Exclusion criteria: 1 Keloid in children. 2 Pregnant and lactating women. 3 Infected or ulcerated keloid. 4 Patients suffering from peripheral vascular disease. 5 Raynaudâ??s phenomenon 6 Concomitant immune defect, heart disease, renal failure, malignancy. 7 Neurological or psychiatric disorders. 8 Participation in any clinical trial within the last 3 months

Design outcomes

Primary

MeasureTime frame
To assess effectiveness of Cryotherapy versus Intralesional Bleomycin injection in reducing the thickness of localised keloid.Timepoint: 6 months

Secondary

MeasureTime frame
To assess the effectiveness of these two different methods in decreasing pain and itching associated with keloid.Timepoint: 6 months;To assess the improvement in quality of life with these mentioned methodsTimepoint: 6 months;To assess tolerability and safety of the mentioned methods.Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Somenath Das

Bankura Sammilani Medical College and Hospital

drdasnilay@gmail.com9433394148

Outcome results

None listed

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