EFFICACY OF ELETTROPORATION COMBINED WITH BLEOMYCIN IN THE TREATMENT OF KELOIDS AND HYPERTROPHIC SCARS: A PILOT STUDY - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013455-30-IT

Enrollment

Registered

2009-10-01

Start date

2009-12-15

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KELOIDS AND HYPERTROPHIC SCARS MedDRA version: 9.1 Level: SOC Classification code 10040785

Interventions

Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bleomycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PRESENCE OF AT LEAST ONE KELOID OR HYPERTROPHIC SCAR LASTING FOR AT LEAST SIX MONTH NON RESPODER LESION PREVIOUS STANDARD TREATMENTS WASHOUT FROM STANDARD THERAPY FOR FOUR WEEKS NORMAL HEPATIC AND RENAL FUNCTION Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: CONCOMITANT LOCAL TREATMENT OF KELOIDS PREGNANCY / LACTATION HYPERSENSITIVITY ARRHYTHMIA OR PACE-MAKER

Design outcomes

Primary

Measure	Time frame
Main Objective: DETERMINATION OF EFFICACY OF ELETTROPORATION COMBINED WITH BLEOMYCIN IN THE TREATMENT OF KELOIDS AND HYPERTROPHIC SCARS BY MEAN OF CLINICAL AND INSTRUMENTAL EVALUATION;Secondary Objective: SAFETY AND TOLERABILITY IDENTIFICATION OF STANDARD OPERATIVE PROCEDURES;Primary end point(s): EVALUATION OF RESPONSE BASED ON VARIATION IN LESION DIMENSION	—

Countries

Italy

Outcome results

None listed

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