Today, we will be looking into the latest research and clinical trials focused on actinic keratosis in adults.
The following list has been carefully curated by evaluating the ongoing phase 3 trials for actinic keratosis, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 3 years.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of actinic keratosis clinical trials!
Quick View Table of Actinic Keratosis Clinical Trials
Phase 3 Actinic Keratosis Clinical Trials:
Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
- Sponsor: Biofrontera Bioscience GmbH
- The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
- Interventions: COMBINATION_PRODUCT: BF-200 ALA and red light LED lamp; COMBINATION_PRODUCT: Vehicle and red light LED lamp
- Primary Outcomes Measures:
- Overall subject complete response rate
- Percentage of subjects with all AK target lesions clinically cleared after last PDT
- 12 weeks after the last PDT (Visit 4 or Visit 6)
Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis
- Sponsor: Encube Ethicals Pvt. Ltd.
- Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites.
- Interventions: DRUG: Test Product (A): Fluorouracil Cream, 5% topical cream|DRUG: Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 US; DRUG: Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India
- Primary Outcomes Measures:
- Therapeutic equivalence with Reference product, Therapeutic equivalence will be evaluated for the primary endpoint at Visit 4 in the PP population. If the 90% confidence interval on the absolute difference between the proportion of subjects who are considered a complete cure in the Test and the Reference product groups (pT – pR) is contained within \[-20%, +20%\], then therapeutic equivalence of the Test product to the Reference product will be considered to have been demonstrated, 6 weeks
- Superiority to Placebo, The superiority of the Test and Reference products against the Placebo product will be evaluated for the primary endpoint at Visit 4 in the modified Intent-to-Treat (mITT) population using the last observation carried forward (LOCF). If the proportion of subjects who are considered a complete cure in the Test and the Reference product groups is numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test, stratified by clinical site), then the superiority of the Test and Reference products over Placebo will be concluded, 6 weeks
- Primary Efficacy Endpoint, The primary efficacy endpoint is the proportion of subjects in each treatment group with treatment success, defined as 100% clearance of all AK lesions (baseline or target AK lesions and any new AK lesions) within the designated treatment area (i.e., complete cure), assessed at study Week 6 (Day 43 ± 4, which is 4 weeks after completion of 2 weeks of treatment), 6 weeks.
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
- Sponsor: Galderma R&D
- A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
- Interventions: DRUG: MAL 16.8% cream; DRUG: MAL Vehicle Cream
- Primary Outcomes Measures:
- Percentage of Participants with Complete Response at Week 12, Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT)., Week 12.
Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
- Sponsor: The Cleveland Clinic
- This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.
- Interventions: PROCEDURE: Aminolevulinic acid based photodynamic therapy
- Primary Outcomes Measures:
- AK clearance, the primary endpoint is treatment efficacy (AK lesion clearance at 3 months). The specific aim of this study is to establish proof-of-principle for the concept that a long delivery period of blue light from the Blu-U device, using the standard fluence rate but starting only 15 min after the application of Levulan and lasting 1 hour (fluence of 360 J/cm2), can provide a clearance rate of AK lesions comparable to a standard regimen of Blu-U light (fluence of 10 J/cm2) beginning 1 hr after LevulanTM application., at 3 months post-treatment.
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
- Sponsor: Galderma R&D
- The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scalp..
- Interventions: COMBINATION_PRODUCT: Metvix-PDT; COMBINATION_PRODUCT: Vehicle-PDT
- Primary Outcomes Measures:
- Participant Complete Response Rate (CRR), Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator., At Week 13.
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
- Sponsor: The Cleveland Clinic
- This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat and prevent recurrence of AKs. The target population comprises patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for possible influences of immunosuppression.
- Interventions:DRUG: 5-Fluorouracil
- Primary Outcomes Measures:
- “Accumulation of Porphyrin (PpIX), The primary endpoint of this study will be the accumulation of PpIX at 3 h after MAL application (measured noninvasively, in each treated region).
- (Region refers to the half-face or half-scalp area treated with PDT monotherapy, or the contralateral area treated with the 5-FU/PDT combination regimen)., Day 7 of the study”
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
- Sponsor: Galderma R&D
- The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.
- Interventions: DRUG: MAL Cream; DRUG: Vehicle cream
- Primary Outcomes Measures:
- Number of Participants with Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54, Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to \[\>=\] 1) cleared treated AK lesions. Number of participants with recurrence of any (\>=1) cleared treated AK lesions at Week 54 was reported., At Week 54
Potential Guideline That May Be Affected Includes:
- Care for the Management of Actinic Keratosis
- American Academy of Dermatology (AAD)
- Publication: March 31, 2021
There you have it – a list of phase 3 clinical trials for actinic keratosis as of November 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.
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