Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Placebo Gel

LAS41005

LAS106521

Estrella Garcia, MD, MBA

The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

To investigate as primary objective:

* Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;

To investigate as secondary objective:

* Superiority to LAS106521
* Improvement of treated lesions (lesion response)
* Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
* Patient's assessment of tolerability and efficacy and patient's compliance

Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II

Almirall, S.A.

LAS41007 o.d.

LAS41007 b.i.d.

Christoph Willers, MD, MBA

The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.

Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis

Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II

All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum.

Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².

LAS41007

LASW1510

vehicle of LAS41007

Dr. Estrella Estrella Garcia, PhD

The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).

Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis

superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion

improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy

Carcinoma

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

AIV001

To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma

An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma

Number of participants cleared of basal cell carcinoma within study duration

AiViva BioPharma, Inc.

Patients who completed Xoft eBx treatment at least five years from the last treatment.

The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source

Xoft eBx

Stephen Doggett, MD

The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.

This is a retrospective-prospective study design. The study is post-market, on-label observational study for the treatment of NMSC. Patients who completed treatment at least five years from the last treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up.

The study will include:

Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.

Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

A Post-market Multi-Center Retrospective-Prospective Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx

Absence of local recurrence at ≥ 5-year follow-up by physician assessment at treatment site(s).

Occurrence of long-term skin toxicities by physician assessment.

Xoft, Inc.

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Tretinoin

Keratolytic Agents

Tretinoin 0.1% cream or placebo

Patients receive placebo for same amount of time

Placebo

Martin A. Weinstock, MD

One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system. Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell and/or basal cell carcinoma were enrolled at six participating centers over a four-year period and were randomly assigned to either 0.1% tretinoin cream or placebo. They were followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences.

Primary Hypothesis: To determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer (NMSC) among high risk individuals (at least 2 NMSC?S in last 5 years).

Secondary Hypothesis: Secondary objectives are: (a) to determine the long-term effect of topical tretinoin on the prevalence of premalignant actinic keratoses, and (b) to distinguish subpopulations in which topical tretinoin is particularly effective or ineffective, compared to the overall study population.

Intervention: Apply Tretinoin 0.1% cream or placebo cream to face and ears twice a day.

Primary Outcomes: New NMSC lesions on the face and ears. Number of actinic keratoses on the face and ears.

Study Abstract: One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system.

Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 1200 patients with a recent history of squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over a four-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo. They will be followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences.

Weinstock, M.A., Bingham, S.F., Cole, G.W., Eilers, D., Naylor, M.F., Kalivas, J., Taylor, J.R., Gladstone, H.B., Piacquadio, D.J., and DiGiovanna, J.J. Reliability of Counting Actinic Keratoses Before and After Brief Consensus Discussion. Arch Dermatol 137:1055-1058, 2001

Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer

CSP #402 - VA Topical Tretinoin Chemoprevention Trial

Ortho Dermatologics

US Department of Veterans Affairs

Weinstock, Martin - Study Chair

Anti-Inflammatory Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Fluorouracil

Tin Fluorides

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses

Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses

Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but 5-FU will be stopped.

5-fluorouracil

Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but vehicle control cream will be stopped.

Placebo, vehicle control

The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer will be compared to the usual cost of treating skin cancer. Participants are being asked to be a part of this study because the participants have been treated for two or more skin cancers within the past five (5) years. At least one of these cancers occurred on the face or ears. Having had two or more skins cancers in the past 5 years makes it likely that participants will develop additional skin cancers in the future.

Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams, or gels that contain sunscreens can help protect the skin from premature aging and damage that may lead to skin cancer.

The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers and spots that might become skin cancer. However, 5-FU skin cream has never been studied to see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be used in this study.

In this study, one half of the patients will use the 5-FU cream and the other half will use a skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active drug in it.

Approximately twelve VA medical centers will work together in this study. About one thousand (1000) patients will be in this study. The study is sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program.

Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin, both of which are keratinocyte carcinomas (KCs), account for a half of all cancers in the United States, and over 100,000 diagnoses per year in the VA. The standard treatment for these KCs is excision of the lesion, and they cost the US health care system some $2.5 billion annually and about $100 million annually in the VA. There is no proven means to prevent KCs (except perhaps for a modest benefit of intensive daily sunscreen use). An effective prevention strategy would dramatically change the way high-risk patients are managed and could substantially reduce the costs of care. The investigators' preliminary analysis indicates that the savings will be $116 per high-risk patient and will account for a total national savings of over $11 million. These findings imply that the study would pay for itself by the end of 4 years. The investigators hypothesize that topical 5-fluorouracil (5-FU) chemoprevention will prevent skin cancer surgeries and will be cost-saving. To test this the investigators propose a randomized controlled trial of 5-FU compared to a vehicle control to the face and ears in a high-risk population.

In the study, 1000 Veterans at high-risk of skin cancer defined as at least 2 KCs in the prior 5 years, at least one of which was on the face or ears, will be randomized to 5-FU or a vehicle control cream, and followed for 2 to 4 years. The primary endpoint will be surgery for any KC on the face and ears. The investigators will also assess the cost of care, quality of life, the side effects associated with treatment, and the prevalence and number of actinic keratoses, a skin cancer precursor and itself a cause of morbidity and cost. By targeting patients at high-risk, the study focuses on high-cost patients for whom this treatment could both improve outcomes (cancers and quality of life) and reduce costs.

CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial

Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.

VA Office of Research and Development

Adverse events collected were those related to the study intervention. Data on adverse events were collected spontaneously through patient reports, actively elicited at each clinic visit through open ended questionings and examination, and gathered at the time of telephone contact during the therapy period. All serious adverse events were collected, including those considered related and unrelated to the study interventions.Subjects were monitored for SAE at each study visit and telephone call.

Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses

5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but 5-FU will be stopped.

Arm 1: 5-fluorouracil

Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses

Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but vehicle control cream will be stopped.

Arm 2: Placebo

Arm 2: Placebo, Vehicle Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Martin Weinstock MD, PhD

Group assigned to blinded 5-fluorouracil (5-FU) cream applied to face and ears twice daily for maximum of 56 doses

5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but 5-FU will be stopped.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis	NCT00987246	Actinic Keratos...	Placebo Gel LAS41005 LAS106521	18 Years - 85 Years	Almirall, S.A.
Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis	NCT00991861	Actinic Keratos...	LAS41007 o.d. LAS41007 b.i.d. LAS106521	18 Years -	Almirall, S.A.
Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis	NCT01265602	Actinic Keratos...	LAS41007 LASW1510 vehicle of LAS4...	18 Years -	Almirall, S.A.
Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma	NCT04470726	Superficial Bas... Nodular Basal C...	AIV001	18 Years - 80 Years	AiViva BioPharma, Inc.
Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx	NCT05257486	Non-melanoma Sk...	Xoft eBx	40 Years -	Xoft, Inc.
Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma	NCT04470726	Superficial Bas... Nodular Basal C...	AIV001	18 Years - 80 Years	AiViva BioPharma, Inc.
Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer	NCT00007631	Carcinoma, Basa... Carcinoma, Squa... Skin Neoplasms	Tretinoin 0.1% ... Placebo	-	VA Office of Research and Development
CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial	NCT00847912	Carcinoma, Basa... Carcinoma, Squa... Skin Neoplasms Skin Diseases Neoplasms, Basa... Neoplasms, Squa... Carcinoma	5-fluorouracil Placebo, vehicl...	-	VA Office of Research and Development
Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx	NCT05257486	Non-melanoma Sk...	Xoft eBx	40 Years -	Xoft, Inc.

Spots Global Cancer Trial Database for nmsc

Every month we try and update this database with for nmsc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nmsc

Every month we try and update this database with for nmsc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nmsc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.