Efficacy Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris
A Double-Blind, Randomized, Placebo-Controlled Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris in Adults
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
1 active site
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
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedApril 7, 2011
April 1, 2011
10 months
May 13, 2010
April 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At the end of the treatment (day 1)
Study Arms (2)
Cryotherapy with EMLA
ACTIVE COMPARATOREMLA applied before cryotherapy
Cryotherapy with placebo analgesia
PLACEBO COMPARATORPlacebo cream applied instead of EMLA
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Dermatology Clinic, National University Hospital
Singapore, Singapore, 119074, Singapore
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Wee Aw, MBBS
National University Hospital, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 13, 2010
First Posted
April 7, 2011
Study Start
February 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 7, 2011
Record last verified: 2011-04