Actinic Keratosis Clinical Trial
Official title:
A Phase IIb Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Topical Bacteriophage T4 Endonuclease V in Renal Allograft Recipients With a History of Non-melanoma Skin Cancer
This randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant. Chemoprevention therapy is the use of certain drugs to try to prevent the development of or recurrence of cancer. T4N5 liposomal lotion may be effective preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant.
PRIMARY OBJECTIVES:
I. Compare the incidence of nonmelanoma skin cancer (NMSC) (average per patient) on the
sun-exposed skin of renal transplant recipients with a history of NMSC treated with T4N5
liposomal lotion vs placebo.
SECONDARY OBJECTIVES:
I. Compare the proportion of these patients who develop NMSC on sun-exposed skin during
treatment and after cessation of treatment with these regimens.
II. Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation
of treatment with these regimens.
III. Compare the incidence of recurrent and de novo actinic keratoses (AKs) in patients
treated with these regimens.
IV. Determine whether either of these regimens induces regression of AKs left untreated on
the sun-exposed skin of these patients.
V. Compare the proportion of these patients who develop melanoma, in both treated and
untreated sites, during and after cessation of treatment with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to study center. Patients are randomized to 1 of 2 arms.
Six months before randomization, lesions suspicious for nonmelanoma skin cancer (NMSC) are
surgically removed and histologically analyzed. All but 10 randomly selected non-suspicious
lesions are removed. Of these 10 lesions, 5 are shave biopsied immediately pre-treatment for
histologic and surrogate endpoint biomarker (SEB) analysis and to determine a baseline
actinic keratosis: wart ratio. Patients also undergo a pre-treatment biopsy of normal
appearing sun-exposed and non-sun-exposed skin (buttocks).
Arm I: Patients apply T4N5 liposomal lotion topically to non-occluded, sun-exposed areas of
the head, neck, face, and upper extremities once daily for 12 months.
Arm II: Patients apply placebo topically to non-occluded, sun-exposed areas of the head,
neck, face, and upper extremities once daily for 12 months.
Treatment in both arms continues in the absence of the development of metastatic cutaneous
squamous cell cancer or melanoma. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 6 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03013647 -
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
|
N/A | |
Completed |
NCT02674048 -
Metvix Daylight PDT in Actinic Keratosis
|
||
Completed |
NCT02421471 -
PMS to Evaluate the Safety and Efficacy of Picato® Gel
|
||
Completed |
NCT02239679 -
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
|
Phase 2 | |
Completed |
NCT01686152 -
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
|
Phase 3 | |
Completed |
NCT01449513 -
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
|
Phase 1 | |
Terminated |
NCT01525329 -
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
|
Phase 3 | |
Completed |
NCT01444989 -
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
|
N/A | |
Terminated |
NCT01203878 -
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
|
Phase 4 | |
Completed |
NCT00989313 -
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study
|
Phase 3 | |
Completed |
NCT00306800 -
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
|
Phase 3 | |
Completed |
NCT00375739 -
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
|
Phase 2 | |
Completed |
NCT03285490 -
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
|
Phase 3 | |
Completed |
NCT03319251 -
Biomarker Database Registry for Photodynamic Therapy
|
||
Completed |
NCT02866695 -
Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
|
Phase 4 | |
Completed |
NCT02952898 -
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
|
Phase 3 | |
Completed |
NCT02984072 -
Menthol for PDT Pain Relief
|
Phase 4 | |
Recruiting |
NCT03684772 -
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
|
Phase 2 | |
Completed |
NCT02878382 -
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
|
N/A | |
Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A |