ACTINIC KERATOSES Clinical Trial
Official title:
Photodynamic Therapy With Levulan® Topical Solution And Blue Light +/- Topical Retinoid Pre-Treatment In The Treatment Of Dorsal Hand/Forearm Actinic Keratoses
To determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac 0.1% gel BID for one week, followed by ALA applied to the entire dorsal hand/forearm 60 minutes prior to BLUE light treatment for 16 minutes 40 seconds Treatment 2 will have ALA applied to the entire dorsal hand/forearm and occluded for 60 minutes prior to BLUE light treatment for 16 minutes 40 secondsNote: ALA will be applied to individual dorsal hand/forearm actinic keratoses (AK) lesions followed by broad area application over the entire dorsal hand/forearm surface. The treatment area on the side NOT pre-treated with Tazorac will then be occluded using plastic wrap for 60 minutes. The treatment area of the dorsal hand/forearm is defined as the extensor surface of the hand/forearm between the elbow and the base of the fingers (the fingers are NOT included in the treatment area). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03575780 -
Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis
|
Phase 1 | |
| Completed |
NCT04085367 -
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
|
Phase 3 | |
| Completed |
NCT05937529 -
Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
|
N/A | |
| Completed |
NCT02520700 -
A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses
|
N/A | |
| Terminated |
NCT01538901 -
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
|
Phase 4 | |
| Completed |
NCT01354717 -
Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo
|
Phase 3 | |
| Completed |
NCT00742391 -
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
|
Phase 3 | |
| Completed |
NCT03285477 -
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
|
Phase 3 | |
| Suspended |
NCT03963102 -
Duration of Ameluz Application in Acral Actinic Keratoses Response
|
Phase 4 | |
| Not yet recruiting |
NCT05923060 -
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
|
Phase 2 | |
| Withdrawn |
NCT06026358 -
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands
|
Phase 4 | |
| Completed |
NCT02622594 -
Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times
|
Phase 4 | |
| Completed |
NCT00786994 -
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
|
Phase 2 | |
| Completed |
NCT00774787 -
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
|
Phase 4 | |
| Completed |
NCT00544258 -
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
|
Phase 1 | |
| Completed |
NCT04024579 -
Treatment of Actinic Keratosis With 5% KOH Solution
|
||
| Completed |
NCT04843553 -
Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients
|
Early Phase 1 | |
| Completed |
NCT03315286 -
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
|
N/A | |
| Completed |
NCT03279328 -
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
|
Phase 4 | |
| Completed |
NCT02062853 -
Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
|
N/A |