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

NCT ID: NCT01330615

Last Updated: 2011-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

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.

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:

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).

Conditions

Plantar Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: TRIPLE

Study Groups

Cryotherapy with EMLA

EMLA applied before cryotherapy

Group Type: ACTIVE_COMPARATOR

EMLA

Intervention Type: DRUG

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.

Cryotherapy with placebo analgesia

Placebo cream applied instead of EMLA

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Eutectic lidocaine/prilocaine cream 5%; Dummy treatment, dummy cream

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

National University Hospital

Principal Investigators

Chen Wee Aw, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

University Dermatology Clinic, National University Hospital

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Chen Wee Aw, MBBS

Role: CONTACT

derrick_AW@nuhs.edu.sg

+6596745647

Chee Wei Teoh, MBBS

Role: CONTACT

chee_wei_TEOH@nuhs.edu.sg

+6593368506

Facility Contacts

Chen Wee Aw, MBBS

Role: primary

derrick_AW@nuhs.edu.sg

+6596745647

Other Identifiers

DSRB-E/09/612

Identifier Type: -

Identifier Source: org_study_id