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Microwave Therapy for Treatment of Precancerous Actinic Keratoses

NCT03483935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-03-06

Study results available
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Summary

This is a two-stage feasibility study to determine if focussed microwave energy is a suitable treatment for Actinic Keratoses (AK).

The two study stages are as follows:

Stage 1:

To determine the electrical properties of permittivity in AK on the hand and bald scalp for subsequent optimisation of the SWIFT instrument to provide the correct dose of microwave energy to the AK.

Stage 2:

1. Evaluate the efficacy of microwave energy as a treatment for AK
2. Evaluate the long-term resolution of AK following microwave treatment
3. Assess the feasibility and acceptability of using microwave energy as a treatment for AK
4. Identify the potential mode of action of microwave energy in the treatment of AK.

The primary objective is to evaluate the efficacy of microwave therapy versus no treatment on the resolution of AK lesions using visual assessment. The primary outcome measure is full or partial resolution of the AK assessed by skin examination.

Conditions

  • Actinic Keratoses
  • Precancerous Skin Lesion

Interventions

OTHER

Microwave treatment

Microwave energy delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for dermatology applications.

Sponsors & Collaborators

  • Emblation Limited

    collaborator INDUSTRY

  • University of Dundee

    lead OTHER

Principal Investigators

  • Charlotte Proby, MBCHB · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483935 on ClinicalTrials.gov