Keratosis, Actinic Clinical Trial
Official title:
Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis
This is a randomized, controlled, multi-center trial in subjects diagnosed with Actinic Keratosis (AK) where each subject serves as their own control. The trial will be conducted at 2 sites, one in Germany and one in the United States. Approximately 60 subjects will be randomized to ensure 51 subjects complete the study.
The primary objective of this trial is to evaluate the efficacy of the Swift Microwave Treatment on resolution of Actinic Keratosis lesions. The secondary objectives of this trial is to evaluate the efficacy, safety and tolerability of Swift Microwave treatment as a therapy for Actinic Keratosis (AK). Eligible subjects who provide written informed consent and have 10, 12 or 14 distinct Actinic Keratosis lesions located on their scalp or hands will be randomized onto the study. Randomization of AK lesions will be stratified by side. Subjects will be randomized to treatment on half the number of AK lesions mapped located on their scalp or hands. The mapped AK lesions not randomized for treatment will receive no treatment (control). The microwave energy applied by the Swift device will be applied to the randomized AK lesion sites for up to 2 treatments, spaced out by a 4-week interval. Follow-up is 2-months after the first treatment is administered where the AK lesions are assessed for resolution. Further follow-up visits occur at 4-months, 6-months and 12-months after the first treatment was administered where the AK lesions will be assessed for resolution or reoccurence. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03076892 -
Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS
|
N/A | |
Terminated |
NCT03076918 -
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
|
N/A | |
Completed |
NCT05356572 -
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
|
N/A | |
Recruiting |
NCT05387525 -
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
|
Phase 4 | |
Completed |
NCT02594644 -
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
|
N/A | |
Active, not recruiting |
NCT02281682 -
IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis
|
Phase 4 | |
Completed |
NCT01458587 -
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
|
Phase 2 | |
Completed |
NCT05260073 -
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
|
||
Active, not recruiting |
NCT06014697 -
OCT and Invasion in Cutaneous Skin Lesions
|
||
Completed |
NCT05279131 -
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
|
Phase 3 | |
Completed |
NCT05481073 -
UV Sensor in Patients With Actinic Keratosis
|
||
Completed |
NCT03697590 -
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
|
Phase 4 | |
Withdrawn |
NCT02813902 -
A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors
|
Phase 1 | |
Completed |
NCT02628236 -
Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
|
Phase 2 | |
Recruiting |
NCT06135415 -
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
|
Phase 3 | |
Completed |
NCT02644187 -
Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol
|
N/A | |
Completed |
NCT02281136 -
MUSE Study of Levulan Kerastick
|
Phase 2 | |
Completed |
NCT05060237 -
Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp
|
Phase 1 | |
Terminated |
NCT04269395 -
A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study
|
Phase 3 |