Trial record 16 of 46 for:    Open Studies | "Warts"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01330615
First received: May 13, 2010
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Plantar Warts
Drug: EMLA
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Pain Visual Analogue Score(VAS) [ Time Frame: At the end of the treatment (day 1) ] [ Designated as safety issue: No ]
    At the end of the treatment i.e.Pain VAS will be assessed 60 mins after application of the study cream


Estimated Enrollment: 64
Study Start Date: February 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cryotherapy with EMLA
EMLA applied before cryotherapy
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%
Placebo Comparator: Cryotherapy with placebo analgesia
Placebo cream applied instead of EMLA
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

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330615

Contacts
Contact: Chen Wee Aw, MBBS +6596745647 derrick_AW@nuhs.edu.sg
Contact: Chee Wei Teoh, MBBS +6593368506 chee_wei_TEOH@nuhs.edu.sg

Locations
Singapore
University Dermatology Clinic, National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Chen Wee Aw, MBBS    +6596745647    derrick_AW@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Chen Wee Aw, MBBS National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Aw Chen Wee, National University Hospital
ClinicalTrials.gov Identifier: NCT01330615     History of Changes
Other Study ID Numbers: DSRB-E/09/612
Study First Received: May 13, 2010
Last Updated: April 6, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
EMLA
plantar warts
cryotherapy

Additional relevant MeSH terms:
Warts
Foot Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Musculoskeletal Diseases
Prilocaine
Lidocaine
EMLA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Combined

ClinicalTrials.gov processed this record on July 22, 2014