Microwave Therapy for Treatment of Precancerous Actinic Keratoses (MTAK)
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|ClinicalTrials.gov Identifier: NCT03483935|
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 1, 2019
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:
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.
- Evaluate the efficacy of microwave energy as a treatment for AK
- Evaluate the long-term resolution of AK following microwave treatment
- Assess the feasibility and acceptability of using microwave energy as a treatment for AK
- 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 greater than 25% full or partial resolution of the AK assessed by skin examination.
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratoses Precancerous Skin Lesion||Other: Microwave treatment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised, internally controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Microwave Therapy for Treatment of Precancerous Actinic Keratoses|
|Actual Study Start Date :||March 7, 2018|
|Actual Primary Completion Date :||February 28, 2019|
|Actual Study Completion Date :||February 28, 2019|
Experimental: Microwave energy treatment
The microwave treatment will be delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for this indication, will be used to deliver the microwave treatment. A measured dose, determined from data acquired from Stage 1 of this study, will be used per AK.
Other: Microwave treatment
Microwave energy delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for dermatology applications.
No Intervention: Control
No treatment will be given.
- Change in AK resolution following microwave treatment [ Time Frame: Baseline, day 8, 15, 28, 42, 60 and 120 ]Clinical examination of affected skin
- Number of participants with treatment related adverse events [ Time Frame: Baseline, day 8, 15, 28, 42, 60 and 120 ]To evaluate the safety and tolerability of microwave treatment as a therapy for AK. Participants will be asked about level and duration of pain during and immediately after treatment. Participants will be asked about the presence of tingling or numbness, itching, red of flaky skin or ulceration.
- Change in Ki67 staining determined immunohistochemically by the use of specific antibodies on fixed material [ Time Frame: Day 15 OR day 42 ]To identify the mode of action of microwave treatment on biomarkers of cell proliferation as a therapy for AK
- Change in Hematoxylin and eosin stain [ Time Frame: Day 15 OR day 42 ]To identify the mode of action of microwave treatment on biomarkers of cell survival
- Change in apoptotic cells determined using the ApopTag peroxidase detection kit [ Time Frame: Day 15 OR day 42 ]To identify the mode of action of microwave treatment on biomarkers of stress response
- Change in gene activity determined by ApopTag Peroxidase [ Time Frame: Day 15 OR day 42 ]To identify the mode of action of microwave treatment on gene activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483935
|Dundee, United Kingdom, DD1 9SY|
|Principal Investigator:||Charlotte Proby, MBCHB||University of Dundee|