Plantar WartsNCT01330615
Efficacy Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris
A study testing EMLA in people with Plantar Warts, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Aims: The investigators main purpose is to assess the efficacy of analgesia provide by topical lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid nitrogen cryotherapy in adults. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Plantar Warts
- What is being tested?
- EMLA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2010to Dec 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (at least 21 years old) with plantar warts
- They must agree for liquid nitrogen cryotherapy for treatment of the plantar warts
- The patients have to be capable of assessing pain using a visual analogue pain scale (VAS)
Who cannot join
- Patients who had previously used EMLA cream® prior to cryotherapy of warts
- Known allergic sensitivity to EMLA cream® or amide type of local anaesthetics.
- Patients with sensory peripheral neuropathy of both lower limbs.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
University Dermatology Clinic, National University Hospital
Singapore, Singapore, 119074
Chen Wee Aw, MBBS, +6596745647, derrick_AW@nuhs.edu.sg
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris in Adults
Aims:
The investigators main purpose is to assess the efficacy of analgesia provide by topical lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid nitrogen cryotherapy in adults.
Read the detailed description
Methodology:
The study is a single-centre, double-blind, randomized, placebo-controlled, parallel-group trial with one visit. The investigators planned to include at least 64 patients in 4 months. Adult patients (at least 21 years old) diagnosed with plantar warts are potential subjects for the study.
Once a potential subject is identified, the field investigator will assess him/her for eligibility to enter the study. Then, the potential subject will be provided with full and adequate verbal and written information about the nature, purpose, possible risks and benefits of the study. If the subject agrees to enroll into the study, a signed informed consent will be obtained from him/her.
All patients are randomly assigned by computer-generated randomization sequence to receive either eutectic lidocaine/prilocaine cream (EMLA)® 5% or placebo 60 mins prior to application of cryotherapy. The plantar warts are pared with shape blade before applying EMLA®or placebo cream. Based on the randomization, an designated dermatology laboratory technician will apply either the EMLA® cream 5% or placebo cream to the wart lesions. The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray. The lesions are treated with double freeze-thaw cycle. The end point of each freeze is a complete ice-ball covering the lesion with 1-2mm peripheral extension. The study involved only one treatment with either placebo or EMLA® cream 5% followed by cryotherapy as described. No other analgesic other than the EMLA® cream 5% or placebo is allowed at least 2 hours prior to or during cryotherapy.
A 100 mm visual analogue pain scale (VAS) is used to denote pain severity ranging from "no pain" (0 mm) to the "worst possible pain" (100 mm). The patient will choose a distance from the "no pain" anchor closest to the pain experienced during cryotherapy for wart removal. Pain is evaluated in each participant using a self-administered VAS immediately after cryotherapy treatment.
Potential Benefits:
The potential benefits are:
- The patients may experience less pain during application cryotherapy.
- The application of local anesthetic cream may possibly increase the effectiveness of cryotherapy.
Potential Risks:
EMLA cream® is known to be relatively safe with minimal side effects. The commonest side effect would be local irritation to the skin e.g. redness, itchiness which is reversible after removal of the cream. Very rarely (<1000), severe allergic reaction can occur with application of EMLA cream® (AstraZeneca information brochure).
- Conditions
- Plantar Warts
- Being tested
- EMLA, Placebo
- Keywords
- EMLA, plantar warts, cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLADrug
Also called Eutectic lidocaine/prilocaine cream 5%
The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray.
PlaceboDrug
Also called Dummy treatment, dummy cream
The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy with EMLA | Active comparator | EMLA applied before cryotherapy Receives: Drug: EMLA |
| Cryotherapy with placebo analgesia | Placebo comparator | Placebo cream applied instead of EMLA Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Score(VAS)
At the end of the treatment i.e.Pain VAS will be assessed 60 mins after application of the study cream
Measured: At the end of the treatment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartsStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Chen Wee Aw, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330615
- Sponsor's protocol ID
- DSRB-E/09/612
- Status last verified
- Apr 2011
- First submitted
- 13 May 2010
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris in Adults
- ClinicalTrials.gov ID
- NCT01330615
- Acronym / sponsor ID
- DSRB-E/09/612
- Conditions
- Plantar Warts
- Keywords
- EMLA, plantar warts, cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 7 Apr 2011 (estimated)
- 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.
Aims:
The investigators main purpose is to assess the efficacy of analgesia provide by topical lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid nitrogen cryotherapy in adults.
Detailed description
Methodology:
The study is a single-centre, double-blind, randomized, placebo-controlled, parallel-group trial with one visit. The investigators planned to include at least 64 patients in 4 months. Adult patients (at least 21 years old) diagnosed with plantar warts are potential subjects for the study.
Once a potential subject is identified, the field investigator will assess him/her for eligibility to enter the study. Then, the potential subject will be provided with full and adequate verbal and written information about the nature, purpose, possible risks and benefits of the study. If the subject agrees to enroll into the study, a signed informed consent will be obtained from him/her.
All patients are randomly assigned by computer-generated randomization sequence to receive either eutectic lidocaine/prilocaine cream (EMLA)® 5% or placebo 60 mins prior to application of cryotherapy. The plantar warts are pared with shape blade before applying EMLA®or placebo cream. Based on the randomization, an designated dermatology laboratory technician will apply either the EMLA® cream 5% or placebo cream to the wart lesions. The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray. The lesions are treated with double freeze-thaw cycle. The end point of each freeze is a complete ice-ball covering the lesion with 1-2mm peripheral extension. The study involved only one treatment with either placebo or EMLA® cream 5% followed by cryotherapy as described. No other analgesic other than the EMLA® cream 5% or placebo is allowed at least 2 hours prior to or during cryotherapy.
A 100 mm visual analogue pain scale (VAS) is used to denote pain severity ranging from "no pain" (0 mm) to the "worst possible pain" (100 mm). The patient will choose a distance from the "no pain" anchor closest to the pain experienced during cryotherapy for wart removal. Pain is evaluated in each participant using a self-administered VAS immediately after cryotherapy treatment.
Potential Benefits:
The potential benefits are:
- The patients may experience less pain during application cryotherapy.
- The application of local anesthetic cream may possibly increase the effectiveness of cryotherapy.
Potential Risks:
EMLA cream® is known to be relatively safe with minimal side effects. The commonest side effect would be local irritation to the skin e.g. redness, itchiness which is reversible after removal of the cream. Very rarely (<1000), severe allergic reaction can occur with application of EMLA cream® (AstraZeneca information brochure).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy with EMLA | Active comparator | Drug: EMLAEMLA applied before cryotherapy |
| Cryotherapy with placebo analgesia | Placebo comparator | Drug: PlaceboPlacebo cream applied instead of EMLA |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (at least 21 years old) with plantar warts
- They must agree for liquid nitrogen cryotherapy for treatment of the plantar warts
- The patients have to be capable of assessing pain using a visual analogue pain scale (VAS)
Key exclusion criteria (3 listed)
- Patients who had previously used EMLA cream® prior to cryotherapy of warts
- Known allergic sensitivity to EMLA cream® or amide type of local anaesthetics.
- Patients with sensory peripheral neuropathy of both lower limbs.
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 |
|---|---|---|
| EMLAAlso: Eutectic lidocaine/prilocaine cream 5%The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray. | Drug | Cryotherapy with EMLA |
| PlaceboAlso: Dummy treatment, dummy creamThe cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray. | Drug | Cryotherapy with placebo analgesia |
Primary outcome
Pain Visual Analogue Score(VAS)
Time frame: At the end of the treatment (day 1)
At the end of the treatment i.e.Pain VAS will be assessed 60 mins after application of the study cream
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
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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.
Chen Wee Aw, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMLA in people with Plantar Warts, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2011. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Wee Aw, MBBS (+6596745647, derrick_AW@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analogue Score(VAS) (time frame: At the end of the treatment (day 1)). 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 7 Apr 2011.