Professor Dirschka Principal Investigator CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany Dr Waibel Principal Investigator Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173
1. Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment. (Time Frame - 2 months post first treatment): Definition:
Treatment Success: complete clearance of ≥75% Actinic Keratosis lesions treated per subject, i.e., at least 75% of the AK lesions treated are fully cleared (not partially cleared).
Secondary outcome:
1. Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment. (Time Frame - 4 and 6 months post first treatment)
2. Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment (Time Frame - 2, 4 and 6 months post first treatment)
3. Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment (Time Frame - 2, 4 and 6 months post first treatment)
4. OCT Analysis as assessed by an AK Classification System (Time Frame - Baseline and 2, 4 and 6 months post first treatment): AK Lesions classified as Not Present, AK I (Grade I mild), AK II (Grade II, moderate) or AK III (Grade III severe)
5. Proportion of subjects with reoccurrence of any Actinic Keratosis lesions at 6 months, as classified by the blinded site investigator. The subject's AK lesion must be classified as completely resolved at 2 months to be considered a reoccurrence. (Time Frame - 6 months post first treatment)
6. Level of pain during treatment using a severity scale (Time Frame - Treatment 1 (Day 0), Treatment 2 (Day 28)): The subject is asked to rate the worst pain experienced during treatment as None, Mild, Moderate or Severe
7. Level of pain after treatment using a severity scale (Time Frame - Treatment 1 (Day 0), Treatment 2 (Day 28)): The subject is asked to rate the worst pain experienced during the 10 minute period after treatment is completed as None, Mild, Moderate or Severe
8. Duration of pain after treatment using a time period scale (Time Frame - Treatment 1 (Day 0), Treatment 2 (Day 28)): For subjects who experienced pain after treatment, the subject is asked to rate the duration of pain experienced during the 10 minute period after treatment using the following time period scales: a few seconds, up to 1 minute, up to 2 minutes, up to 3 minutes, Still Sore.
9. Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system (Time Frame - 2, 4 and 6 months post first treatment): Photographs of each treated and non-treated AK lesion will be assessed by the independent blinded assessors for cosmetic outcome as "excellent" (slight redness or pigmentation change), "good" (moderate redness or pigmentation change), "fair" (slight-to-moderate scarring, atrophy or induration), or "poor" (extensive scarring, atrophy or induration). Each assessment compares the photos taken at the current visit against the photos taken at the previous visit. The assessments by each independent blinded assessor is recorded separately.
10. Severity and occurrence of Adverse Events (Time Frame - Up to 12 months post first treatment)
11. Evaluation of Patient Reported Outcome (PRO) at baseline and 6 months post first treatment using a rating scale (Time Frame - Baseline and 6 months post first treatment): At Baseline, the subject will be asked to rate how their AK lesions affect their daily activities, lifestyle and mood as: none, mild, moderate and severe.
At 6-months post first treatment, the subject will be asked to rate how their daily activities, lifestyle and mood are now affected, when compared to before study treatment as: significantly better, better, unchanged, worse, significantly worse.
The results at baseline and at 6 months post first treatment will be evaluated.
12. Evaluation of Quality of Life (QoL) questionnaires at baseline and 6 months post first treatment using the Dermatology Life Quality Index (DLQI) questionnaire (Time Frame - Baseline and 6 months post first treatment): The DLQI questionnaire measures how the AK lesions have affected the subject's life over the past week. The score at baseline and at 6 months post first treatment will be evaluated.
13. Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale (Time Frame - 6 months post first treatment): The subject will be asked to rate the AK lesions that were treated compared to before treatment as: significantly better, better, unchanged, worse, significantly worse.
14. Long term follow-up of subjects with reoccurrence at 12 months as classified by the blinded site investigator (Time Frame - 12 months post first treatment)
Experimental: Microwave Treatment (Swift System) 3-4 Watts applied locally for up to a 3 second burst to each AK lesion, repeated 3 times per lesion. Burst is defined as a single delivery of microwave energy. There will be approximately 20 seconds between each repeat dose.
No Intervention: No Treatment No Treatment administered
Swift System: Localized microwave energy applied to the distinct AK lesion. Each subject will receive treatment for a maximum of 2 visits (4-week interval between treatment).
For AK lesions assessed as "Thin" AK (Olsen Grades 1 and 2): Set at 3W and apply locally for up to a 3 second burst and adjust the dose and duration. Repeat on the same AK lesion as is tolerable for the subject (3 repetitions). There will be approximately 20 seconds between each repeat dose.
For AK lesions assessed as "Thick" AK (Olsen Grade 3): Set at 4W and apply locally for up to a 3 second burst and adjust the dose and duration. Repeat on the same AK lesion as is tolerable for the subject (3 repetitions).
As the AK lesions may be larger than 3mm in diameter, the dose administered to one AK lesion may require overlapping applications with the applicator tip. Ensure there is approximately 20 seconds between each repeat dose administered
Quelle: ClinicalTrials.gov
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