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Efficacy Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris

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ClinicalTrials.gov Identifier: NCT01330615
Recruitment Status : Unknown
Verified April 2011 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : April 7, 2011
Last Update Posted : April 7, 2011
Sponsor:
Information provided by:
National University Hospital, Singapore

May 13, 2010
April 7, 2011
April 7, 2011
February 2010
December 2010   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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:

  1. The patients may experience less pain during application cryotherapy.
  2. 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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Plantar Warts
  • Drug: EMLA
    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.
    Other Name: Eutectic lidocaine/prilocaine cream 5%
  • Drug: Placebo
    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.
    Other Name: Dummy treatment, dummy cream
  • Active Comparator: Cryotherapy with EMLA
    EMLA applied before cryotherapy
    Intervention: Drug: EMLA
  • Placebo Comparator: Cryotherapy with placebo analgesia
    Placebo cream applied instead of EMLA
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
64
Same as current
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult patients (at least 21 years old) with plantar warts
  2. They must agree for liquid nitrogen cryotherapy for treatment of the plantar warts
  3. The patients have to be capable of assessing pain using a visual analogue pain scale (VAS)

Exclusion Criteria:

  1. Patients who had previously used EMLA cream® prior to cryotherapy of warts
  2. Known allergic sensitivity to EMLA cream® or amide type of local anaesthetics.
  3. Patients with sensory peripheral neuropathy of both lower limbs.
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01330615
DSRB-E/09/612
No
Not Provided
Not Provided
Aw Chen Wee, National University Hospital
National University Hospital, Singapore
Not Provided
Principal Investigator: Chen Wee Aw, MBBS National University Hospital, Singapore
National University Hospital, Singapore
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP