Seborrheic KeratosisNCT05353374
Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization
A study testing Sodium Fusidate 2 % Topical Ointment and Petrolatum ointment in people with Seborrheic Keratosis and Acrochordon, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Keratosis, Acrochordon
- What is being tested?
- Sodium Fusidate 2 % Topical Ointment and Petrolatum ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization: A Double-Blind Randomized Controlled Trial
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.
Read the detailed description
All eligible participants were randomized to be applied sodium fusidate ointment (intervention) or white petrolatum (control) on the lesions on their face with 1:1 ratio. 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.
Electrosurgery was carried out using Ellman® Surgitron. Prior to the cauterization, we performed infiltration anesthesia around the lesion with Pehacain® (containing 20 mg of lidocaine and 0.0125 mg/ml epinephrine). The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment or petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. This sheet contained information on how to wash the face or body properly, how to apply the ointment properly, what to avoid after procedure (rubbing the wound excessively, use make up, sweating excessively, and use other topical agents on the wound), and follow-up instructions (on the 3rd, 7th, and 14th day). Each subject was given two or four pots of ointment that should be applied twice daily on the wound.
Wound monitoring, which includes erythema, edema, crusting, re-epithelialization, total wound healing score, pus, and subjective symptoms was performed on the 3rd, 7th, and 14th day. Erythema scores was also monitored immediately after electrosurgery. Monitoring can be done 1 day earlier or later than schedule in some cases since the wound healing phase is expected still the same. Clinical grading of each site was carried out using a 5-point analog scale for erythema, edema, crusting, re-epithelialization, and total wound healing score.
- Conditions
- Seborrheic Keratosis, Acrochordon
- Being tested
- Sodium Fusidate 2 % Topical Ointment, Petrolatum ointment
- Keywords
- wound healing, cauterization, sodium fusidate ointment, petrolatum
- Medical subject headings
- Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fusidate 2 % Topical OintmentDrug
Also called Fucidin ointment
Sodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days.
Petrolatum ointmentDrug
Also called Vaseline album
Petrolatum ointment was applied twice daily on the wound after cauterization for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Petrolatum ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (5)
Erythema
Skin erythema around the wound, assessed with physical examination. Erythema score is as follows: 0 = no erythema, 1 = mild erythema (25%), 2 = moderate erythema (50%), 3 = severe erythema (75%), and 4 = very severe erythema (100%)
Measured: 14 days
Edema
Edema on the wound area, assessed with physical examination. Edema score is as follows: 0 = no edema, 1 = mild edema (25%), 2 = moderate edema (50%), 3 = severe edema (75%), and 4 = very severe edema (100%)
Measured: 14 days
Crusts
Presence of crusts on the surface of the wound, assessed with physical examination. Crusts score is as follows: 0 = none, 1 = a few (1-30%), 2 = moderate (31-60%), 3 = a lot (61-90%), and 4 = generalized (91-100%)
Measured: 14 days
Reepithelization
Improvement of the wound characterized by decreasing size and depth of the wound, assessed with physical examination. Reepithelization score is as follows: 0 = complete (91-100%), 1 = good (61-90%), 2 = moderate (1-30%), and 4 = poor (0% or widening of the wound)
Measured: 14 days
Incidence of infection
Presence of wound infection, established by findings of pain, erythema, edema, and poor reepithelization
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jan 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic KeratosisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Firman Parrol, Universitas Indonesia
- Investigators
- Firman Parrol, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353374
- Sponsor's protocol ID
- 20-11-1406
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05353374
- Acronym / sponsor ID
- 20-11-1406
- Conditions
- Seborrheic Keratosis, Acrochordon
- Keywords
- wound healing, cauterization, sodium fusidate ointment, petrolatum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All eligible participants were randomized to be applied sodium fusidate ointment (intervention) or white petrolatum (control) on the lesions on their face with 1:1 ratio. 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.
Electrosurgery was carried out using Ellman® Surgitron. Prior to the cauterization, we performed infiltration anesthesia around the lesion with Pehacain® (containing 20 mg of lidocaine and 0.0125 mg/ml epinephrine). The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment or petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. This sheet contained information on how to wash the face or body properly, how to apply the ointment properly, what to avoid after procedure (rubbing the wound excessively, use make up, sweating excessively, and use other topical agents on the wound), and follow-up instructions (on the 3rd, 7th, and 14th day). Each subject was given two or four pots of ointment that should be applied twice daily on the wound.
Wound monitoring, which includes erythema, edema, crusting, re-epithelialization, total wound healing score, pus, and subjective symptoms was performed on the 3rd, 7th, and 14th day. Erythema scores was also monitored immediately after electrosurgery. Monitoring can be done 1 day earlier or later than schedule in some cases since the wound healing phase is expected still the same. Clinical grading of each site was carried out using a 5-point analog scale for erythema, edema, crusting, re-epithelialization, and total wound healing score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium fusidate ointment | Experimental | Drug: Sodium Fusidate 2 % Topical OintmentElectrosurgery 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. |
| Petrolatum | Placebo comparator | Drug: Petrolatum ointmentElectrosurgery 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Fusidate 2 % Topical OintmentAlso: Fucidin ointmentSodium fusidate 2% topical ointment was applied twice daily on the wound after cauterization for 14 days. | Drug | Sodium fusidate ointment |
| Petrolatum ointmentAlso: Vaseline albumPetrolatum ointment was applied twice daily on the wound after cauterization for 14 days. | Drug | Petrolatum |
Primary outcome
Wound healing score
Time frame: 14 days
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
5 secondary outcomes
Erythema
Time frame: 14 days
Edema
Time frame: 14 days
Crusts
Time frame: 14 days
Reepithelization
Time frame: 14 days
Incidence of infection
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firman Parrol, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fusidate 2 % Topical Ointment and Petrolatum ointment in people with Seborrheic Keratosis and Acrochordon, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing score (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.