Assessing effectiveness of topical gentamicin cream in junctional and dystrophic epidermolysis bullosa

Pilot study to assess the effectiveness of topical gentamicin in a collagen base versus paraffin guaze dressings in promoting wound healing in patients with Junctional and Dystrophic Epidermolysis bullosa

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015422

Enrollment

Registered

2018-08-23

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: null- Epidermolysis bullosa - Junctional and Dystrophic

Interventions

Intervention1: Topical gentamicin in a collagen base: 0.1 % ( w/w) Gentamicin in purified Type-1 collagen twice daily for 12 weeks. Control Intervention1: Paraffin Guaze Dressings: standard paraffin g

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Patients with clinical diagnosis of EB and confirmed by IHC and/or molecular diagnosis 2. Patients will be eligible for recruitment irrespective of gender. 3. Treatment naÃ¯ve patients, which have not taken any treatment in the past six weeks and not on any systemic antibiotics

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients who have received any treatment in the past e.g. patients on topical/systemic antibiotics etc in the last 6 weeks 2. Patients with frank secondary bacterial infection or sepsis 3. Patients with infected wounds 4. Age <2 years

Design outcomes

Primary

Measure	Time frame
Primary Outcome 1. Frequency of healed erosions on right versus left side 2. Number of erosions on right versus left side 3. Number of days required for erosions to heal on right versus left side 4. To compare the clinical improvement in blister healing score with visual analogue score, physician global assessment and time taken to improve 2. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 24 weeksTimepoint: Primary Outcome 1. Frequency of healed erosions on right versus left side 2. Number of erosions on right versus left side 3. Number of days required for erosions to heal on right versus left side 4. To compare the clinical improvement in blister healing score with visual analogue score, physician global assessment and time taken to improve 2. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 24 weeks	—

Measure

Time frame

Primary Outcome 1. Frequency of healed erosions on right versus left side 2. Number of erosions on right versus left side 3. Number of days required for erosions to heal on right versus left side 4. To compare the clinical improvement in blister healing score with visual analogue score, physician global assessment and time taken to improve 2. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 24 weeksTimepoint: Primary Outcome 1. Frequency of healed erosions on right versus left side 2. Number of erosions on right versus left side 3. Number of days required for erosions to heal on right versus left side 4. To compare the clinical improvement in blister healing score with visual analogue score, physician global assessment and time taken to improve 2. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 24 weeks

—

Secondary

Measure	Time frame
Secondary outcomes: 1. To assess the change in expression of proteins using IF positivity before and after treatment in right versus left sideTimepoint: 12 weeks and 24 weeks	—

Countries

India

Contacts

Public ContactDr Rahul Mahajan

PGIMER Chandigarh

drrahulpgi@yahoo.com1722756562

Outcome results

None listed

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