N/A
N=7
Microwave Therapy for Treatment of Precancerous Actinic Keratoses
Actinic Keratoses · Precancerous Skin Lesion
Bottom Line
View on ClinicalTrials.gov: NCT03483935 ↗Enrolled (actual)
7
Serious AEs
5.6%
Results posted
Feb 2021
Primary outcome: Primary: Resolution of AK Lesions Following Microwave Treatment — 73; 2; 73; 7 AK lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microwave treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Dundee
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of AK Lesions Following Microwave Treatment |
73; 2; 73; 7; 86; 9 | — |
| PRIMARY Complete Resolution of AKs Following Microwave Treatment |
4; 1; 7; 1; 20; 2 | — |
| PRIMARY Partial Resolution of AKs Following Microwave Treatment |
69; 1; 66; 6; 66; 7 | — |
| SECONDARY Level of Pain Experienced During Treatment |
7; 5; 32; 27; 54; 19 | — |
| SECONDARY Duration of Pain Post Treatment |
7; 8; 2; 2; 1; 0 | — |
| SECONDARY Change in Ki67 Staining Determined Immunohistochemically by the Use of Specific Antibodies on Fixed Material |
9; 1; 1 | — |
| SECONDARY Change in Hematoxylin and Eosin Stain |
11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female participants
- Age 18 years and over
- Clinical diagnosis of precancerous Actinic Keratosis made by a dermatologist
- Able to perform study assessments
Exclusion Criteria
- Inability to give informed consent
- Implantable Cardioverter-defibrillator (ICD), pacemaker or other implantable device
- Metal implants at site of treatment
- Known allergy or intolerance to microwave therapy
- Unstable co-morbidities (cardiovascular disease, active malignancy, vasculopathy, inflammatory arthritis) which, in the opinion of the Chief Investigator (CI), would make the patient unsuitable to be enrolled in the study.
- Individuals who are immunosuppressed (organ transplant recipients, haematologic malignancies, HIV).
- Individuals will not be enrolled to the study if they are participating in the clinical phase of another interventional trial or have done so within the last 30 days. Individuals who are participating in the follow-up phase of another interventional trial, or who are enrolled in an observational study, will be co-enrolled where the CIs of each study agree that it is appropriate.
Data sourced from ClinicalTrials.gov (NCT03483935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.