18 and older, any sex, with Actinic Keratoses or Precancerous Skin Lesion. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Resolution of AK Lesions Following Microwave TreatmentPrimary· Baseline, day 8, 15, 28, 42, 60 and 120
The resolution of each treated AK lesion will be determined by clinical assessment. Resolution is predetermined as either partial (resolution of the area covered by the microwave probe, but with a rim or persistent AK) or full (complete resolution of the entire AK) over all time periods. Response will be assessed at visits 3 (day 8), 4 (day 15), 6 (day 28), 8 (day 42), 10 (day 60) and 11 (day 120). Mixed-effects logistic regression models analysed the effect of microwave therapy with random effects for participant and visit (≤ 6 per participant). Each visit will be analysed as a categorical va
Day 8
Group
Value
95% CI
Microwave Energy Treatment
73
Control
2
Day 15
Group
Value
95% CI
Microwave Energy Treatment
73
Control
7
Day 28
Group
Value
95% CI
Microwave Energy Treatment
86
Control
9
Day 42
Group
Value
95% CI
Microwave Energy Treatment
86
Control
9
Day 60
Group
Value
95% CI
Microwave Energy Treatment
81
Control
11
Day 120
Group
Value
95% CI
Microwave Energy Treatment
84
Control
13
Complete Resolution of AKs Following Microwave TreatmentPrimary· Baseline, day 8, 15, 28, 42, 60 and 120
The resolution of each treated AK lesion will be determined by clinical assessment. Resolution is predetermined as either partial (resolution of the area covered by the microwave probe, but with a rim or persistent AK) or full (complete resolution of the entire AK) over all time periods. Treatment will be given at day 1, with a second treatment on day 28 based on a clinical decision. Response will be assessed at visits 3 (day 8), 4 (day 15), 6 (day 28), 8 (day 42), 10 (day 60) and 11 (day 120). Clinical photos will be taken at each hospital visit. Mixed-effects logistic regression models analy
Day 8
Group
Value
95% CI
Microwave Energy Treatment
4
Control
1
Day 15
Group
Value
95% CI
Microwave Energy Treatment
7
Control
1
Day 28
Group
Value
95% CI
Microwave Energy Treatment
20
Control
2
Day 42
Group
Value
95% CI
Microwave Energy Treatment
23
Control
3
Day 60
Group
Value
95% CI
Microwave Energy Treatment
41
Control
5
Day 120
Group
Value
95% CI
Microwave Energy Treatment
39
Control
6
Partial Resolution of AKs Following Microwave TreatmentPrimary· Baseline, day 8, 15, 28, 42, 60 and 120
The resolution of each treated AK lesion will be determined by clinical assessment. Resolution is predetermined as either partial (resolution of the area covered by the microwave probe, but with a rim or persistent AK) or full (complete resolution of the entire AK) over all time periods. Treatment will be given at day 1, with a second treatment on day 28 based on a clinical decision. Response will be assessed at visits 3 (day 8), 4 (day 15), 6 (day 28), 8 (day 42), 10 (day 60) and 11 (day 120). Clinical photos will be taken at each hospital visit. Mixed-effects logistic regression models analy
Day 8
Group
Value
95% CI
Microwave Energy Treatment
69
Control
1
Day 15
Group
Value
95% CI
Microwave Energy Treatment
66
Control
6
Day 28
Group
Value
95% CI
Microwave Energy Treatment
66
Control
7
Day 42
Group
Value
95% CI
Microwave Energy Treatment
63
Control
6
Day 60
Group
Value
95% CI
Microwave Energy Treatment
40
Control
6
Day 120
Group
Value
95% CI
Microwave Energy Treatment
45
Control
7
Level of Pain Experienced During TreatmentSecondary· Treatment 1 (day 1) and treatment 2 (day 28)
To evaluate the safety and tolerability of microwave treatment as a therapy for AK, participants were asked about level of pain during treatment. Participants were asked to rate their pain level during each treatment as i) mild, ii) moderate or iii) severe.
Mild pain during treatment
Group
Value
95% CI
Treatment 1
7
Treatment 2
5
Moderate pain during treatment
Group
Value
95% CI
Treatment 1
32
Treatment 2
27
Severe pain during treatment
Group
Value
95% CI
Treatment 1
54
Treatment 2
19
Duration of Pain Post TreatmentSecondary· Treatment 1 (day 1) and Treatment 2 (day 28)
To evaluate the safety and tolerability of microwave treatment as a therapy for AK, participants were asked about the duration of pain immediately after each treatment. Duration was grouped into 5 pre-determined periods, i) few seconds, ii) up to 5 minutes, iii) up to 10 minutes, iv) up to 20 minutes and v) over 30 minutes. The decision to administer a second treatment was made by the investigator.
Duration: Few seconds
Group
Value
95% CI
Treatment 1
7
Treatment 2
8
Duration: Up to 5 minutes
Group
Value
95% CI
Treatment 1
2
Treatment 2
2
Duration: Up to 10 minutes
Group
Value
95% CI
Treatment 1
1
Treatment 2
0
Duration: Up to 20 minutes
Group
Value
95% CI
Treatment 1
1
Treatment 2
0
Duration: Over 30 minutes
Group
Value
95% CI
Treatment 1
0
Treatment 2
0
Change in Ki67 Staining Determined Immunohistochemically by the Use of Specific Antibodies on Fixed MaterialSecondary· Day 15
To identify the mode of action of microwave treatment on biomarkers of cell proliferation as a therapy for AK. Results are provided on the staining positivity scale of +, ++ and +++. The minimum value is + , meaning the least staining. The maximum value is +++, meaning the most staining identified.
Group
Value
95% CI
Microwave Energy Treatment
9
Microwave Energy Treatment
1
Microwave Energy Treatment
1
Change in Hematoxylin and Eosin StainSecondary· Day 15 OR day 42
To identify the mode of action of microwave treatment on biomarkers of cell survival.
Group
Value
95% CI
Change in Hematoxylin and Eosin Stain
11
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected from the date of consent until the participant's last study visit. For Stage 1, study duration was 1 day. For stage 2, RCT, maximum participant duration on the trial was 35 days washout period (if required) and 120 days trial duration. SAEs were followed up for both stages until 30 days after the participant's last visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06499415 — Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
· Phase 4
· recruiting
NCT06385340 — Investigation of the Effect of Lipikar Baume AP+M
· NA
· recruiting
NCT06321003 — SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
· recruiting
NCT05202860 — Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis
· Phase 2
· active not recruiting
NCT05976061 — High- and Low-risk Actinic Keratosis Referrals to Secondary Care
· active not recruiting
Other University of Dundee trials
Trials by the same sponsor.
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· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Dundee
Last refreshed: 6 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03483935.