NCT05353374

Brief Summary

A double-blind within person randomized controlled trial study was conducted on 90 wounds in 22 subjects. All wounds were randomized to receive either sodium fusidate ointment or petrolatum following cauterization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 23, 2022

Last Update Submit

April 29, 2022

Conditions

Seborrheic KeratosisAcrochordon

Keywords

wound healingcauterizationsodium fusidate ointmentpetrolatum

Outcome Measures

Primary Outcomes (1)

  • Wound healing score

    Wound healing score was calculated based on the erythema, edema, crusts, and reepithelization. Wound healing score is as follows: 0-4 = very good/healed, 5-8 good/healed, 9-12 moderate/not healed, and 13-16 = poor/not healed

    14 days

Secondary Outcomes (5)

  • Erythema

    14 days

  • Edema

    14 days

  • Crusts

    14 days

  • Reepithelization

    14 days

  • Incidence of infection

    14 days

Study Arms (2)

Sodium fusidate ointment

EXPERIMENTAL

Electrosurgery was carried out using Ellman® Surgitron. The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Drug: Sodium Fusidate 2 % Topical Ointment

Petrolatum

PLACEBO COMPARATOR

Electrosurgery was carried out using Ellman® Surgitron. The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Drug: Petrolatum ointment

Interventions

Sodium Fusidate 2 % Topical OintmentDRUG

Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.

Also known as: Fucidin ointment
Sodium fusidate ointment
Petrolatum ointmentDRUG

Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.

Also known as: Vaseline album
Petrolatum

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 20 years
  • clinically diagnosed with seborrheic keratosis or acrochordon
  • having minimum of two lesions and maximum of four lesions with diameter of 4-10 mm on face or neck and minimum distance between lesions of 5 cm
  • providing consent to participate into the study

You may not qualify if:

  • a skin bacterial infection on the other parts of body's skin
  • benign tumor lesions with inflammation or secondary infection
  • history of antibiotics use in the last 2 weeks or long-acting penicillin injections within the past 1 month
  • history of corticosteroids and immunosuppressants use in the past 2 weeks
  • using a pacemaker
  • infected with Coronavirus disease 2019 (Covid-19).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Keratosis, Seborrheic

Interventions

Fusidic AcidOintments

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CholestadienolsCholestadienesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsMembrane LipidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Firman Parrol, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation sequence was generated by a statistician with a computer and it was concealed from the researchers and participants. The ointment was prepared and packaged by a pharmacist. Each pot was numbered in accordance with the allocation sequence.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatology Resident

Study Record Dates

First Submitted

April 23, 2022

First Posted

April 29, 2022

Study Start

January 1, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)