Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

2.3% of SM in Solanum undatum plant extract

Vehicle gel

SR-T100 with 2.3% of SM

This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).

Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis

A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)

The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) .

The proportion of patients achieving ≥ 75% total clinically assessed AK lesion counts out of all target lesions in the treatment area (in total of 25cm2 area) at the post-EOT visit (8 weeks after EOT visit).

G&E Herbal Biotechnology Co., LTD

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.

Exanthema

0.0025% PEP005 Topical Gel (Day 1,2 application)

PEP005

0.01% PEP005 Topical Gel (Day 1,2 application)

0.05% PEP005 Topical Gel (Day 1,2 application)

0.0025% PEP005 Topical Gel (Day 1,8 application)

0.01% PEP005 Topical Gel (Day 1,8 application)

0.05% PEP005 Topical Gel (Day 1,8 application)

Greg Siller

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

Peplin

Janelle Katsamas

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

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Anti-Infective Agents

Fluorouracil

Aminolevulinic Acid

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).

5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.

20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.

5-ALA plus Blu-Light

Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.

5-FU, Imiquimod or treatment with cryotherapy

Maria Tsoukas, MD

The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).

Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)

University of Chicago

Photodynamic Therapy

Cryosurgery

Rolf-Marcus Szeimies, Professor MD

The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.

Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). In Europe, cryosurgery is the method primarily used and will therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be necessary to validate the test system. While the comparison of PD P 506 A-PDT and cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a double-blind manner.

PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK

Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis

photonamic GmbH & Co. KG

Sunscreening Agents

Protective Agents

Radiation-Protective Agents

Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.

Eryfotona AK-NMSC® cream

Sunscreen SPF 50+

Dr. Giuseppe Argenziano,, MD, PhD

The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.

Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis

A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.

Comparison between treatment groups at the end of the treatment period

Comparison between treatment groups at the end of the treatment period Validation of a new RCM score

Comparison between treatment groups over time and at the end of the treatment period

ISDIN

Axel Hauschild, Professor MD

The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.

Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). A direct comparison versus placebo which is necessary for the exact quantification of the effect of PD P 506 A has not yet been performed and is subject of this study protocol.

Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK

PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy of Mild to Moderate Actinic Keratosis

Symptoms and General Pathology

Recurrence

Imiquimod 5% cream

This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis	NCT01516515	Actinic Keratos...	Vehicle gel SR-T100 with 2....	18 Years -	G&E Herbal Biotechnology Co., LTD
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.
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses	NCT00107965	Actinic Keratos...	PEP005 PEP005 PEP005 PEP005 PEP005 PEP005 PEP005 PEP005	18 Years -	Peplin
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.
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses	NCT00814528	Actinic Keratos...	5-ALA plus Blu-... 5-FU, Imiquimod...	18 Years - 95 Years	University of Chicago
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses	NCT00814528	Actinic Keratos...	5-ALA plus Blu-... 5-FU, Imiquimod...	18 Years - 95 Years	University of Chicago
PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK	NCT00308867	Actinic Keratos...	Photodynamic Th... Cryosurgery	18 Years -	photonamic GmbH & Co. KG
PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK	NCT00308867	Actinic Keratos...	Photodynamic Th... Cryosurgery	18 Years -	photonamic GmbH & Co. KG
Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis	NCT01656226	Actinic Keratos...	Eryfotona AK-NM... Sunscreen SPF 5...	18 Years -	ISDIN
Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK	NCT00308854	Actinic Keratos...	Photodynamic Th...	18 Years -	photonamic GmbH & Co. KG
1-Year Follow up to the 1473-IMIQ Study	NCT00114023	Keratosis	Imiquimod 5% cr...	18 Years -	Graceway Pharmaceuticals, LLC

Spots Global Cancer Trial Database for ak

Every month we try and update this database with for ak 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 ak

Every month we try and update this database with for ak 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 ak 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.