Neoplasms

Immune System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Mastocytosis

Mastocytosis, Cutaneous

Mastocytoma

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Mast Cell Activation Disorders

Skin Neoplasms

Skin Diseases

Cutaneous Mastocytosis

TF 002

Marcus Maurer, Prof

The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on Darier´s signs and the histological evaluation of mast cell numbers in skin bioptic material.

This is a randomised, double-blind, placebo- and active-controlled study with intra-individual comparison of test areas.

The primary study target is to evaluate the safety and efficacy of TF002 for the treatment of cutaneous mastocytosis or systemic mastocytosis with skin involvment. The treatment period of 14 days was adjusted to the maximum recommended treatment period for the comparator Dermoxinale®.

Since there are no approved therapies for this indication a placebo controlled design was chosen.

There are some reports about transient treatment effects using high potent steroids like clobetasol in mastocytosis. This triggered the decision to use Dermoxinale® as positive control.

To validate the clinical scores used in the study, surrogate markers describing the Darier´s sign (thermography, volumetric test) will be evaluated optionally.

Efficacy and Safety of TF002 in Cutaneous Mastocytosis

JADO Technologies GmbH

Keratosis, Actinic

Keratosis

Precancerous Conditions

Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.

Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK

Ingenol mebutate 0.015 percent or 0.05 percent gel

Sun Choi, B.Sc.

This study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of actinic keratosis.

Each patient is observed for 8 weeks after treatment completion.

Picato® (ingenol mebutate) gel is a new topical therapy for Actinic Keratosis (AK) in adults which was approved by the Korean Ministry of Food and Drug Safety (MFDS) in December 2013. For AK in face or scalp the 0.015 percent gel is approved to be applied once a day for 3 consecutive days, and for AK in trunk or extremities the 0.05 percent gel is approved to be applied once a day for 2 consecutive days.

The re-examination period for Picato® runs from December 2013 to December 2019, during which at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment must be documented in a standard Post Marketing Surveillance (PMS) study.

Each patient is to be observed for 8 weeks following application of ingenol mebutate gel. If a patient is unable to visit the PMS site, the investigator may contact the patient by phone to assess the safety.

PMS to Evaluate the Safety and Efficacy of Picato® Gel

Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel

According to Korean definition and classification, covering serious as well as non-serious Adverse Events, related as well as non-related to ingenol mebutate treatment

Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline

Proportion of patients with no clinically visible AK lesions in treated area

Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline

Percentage change in the total number of AK lesions in treated area compared to baseline

LEO Pharma

Application of AVX001 1% gel to treatment field once daily

Application of AVX001 3% gel to treatment field once daily.

Application of AVX001 vehicle gel to treatment field once daily

Topical gel treatment for once daily application

AVX001

Merete Haedersdal, MD, PhD

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer.

The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

A Single-center, Randomized Double-blind, Vehicle-controlled, Dose-ranging Decentralised Clinical Trial to Evaluate the Safety and Efficacy of Daily Field-directed Topical Applications of AVX001 Silicone-based Gel in Doses of 1% or 3% in Adult Subjects With Multiple Actinic Keratosis Lesions Olsen Grade 1 or 2

Studies&Me

Bispebjerg Hospital

Coegin Pharma AB

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Head and Neck Neoplasms

Quality of Life

All Drugs and Chemicals

Herbal and Botanical

Mitogens

Lemon Balm

Use of Cicaplast balm B5, 2 to 3 applications per day, since the first day of iEGFR treatment initiation for 30 days to avoid or limit appearance of cutaneous toxicities related to iEGFR treatment.

Use of Dexeryl, 2 to 3 applications per day, since de first day of iEGFR treatment initiation for 30 days to avoid or limit appearence of cutaneous toxicities related to iEGFR treatment.

The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers

Cicaplast Balm B5

Dexeryl

Jérôme FAYETTE, Doctor

This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer).

Although having a much better tolerance profile than the "classical" cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia).

The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment.

Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity.

In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity.

There is, however, no validated argument in the literature to guide the choice of clinicians to use either of these topics. Cicaplast balm B5 (antibacterial, repairing damaged skin, moisturizing and relieving feelings of discomfort) would limit the aggravation of skin toxicities and therefore the use of pharmacological measures, including topical corticosteroids class 3 or 4 may long term, weaken the skin barrier even more.

This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

Arm A : Use of Cicaplast balm B5 since de first day of iEGFR initiation treatment for 30 days Arm B : Use of Dexeryl cream since de first day of iEGFR initiation treatment for 30 days

Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)

Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers

Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm

Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm

Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)

Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4

Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity

Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm

Topical observance will be evaluated in each arm by data collection by each patient in a diary

Evaluation of the rate of patients needing to use dermocorticoids.

Centre Leon Berard

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Vulvar Neoplasms

Papillomavirus Infections

Vulvar Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Anti-Infective Agents

Antineoplastic Agents

Artesunate

Artemisinins

Artemisinin

Artenimol

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Antiviral Agents

Anthelmintics

Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks

Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

topical ointment, as a non-surgical treatment

Artesunate ointment

Placebo ointment

Mihaela Plesa

Ahmad Bayat, MD

Edward C. Grendys, MD FACOG, FACS

Donna White

Megan Park

Chad Michener, MD

Mariam AlHilli, MD

Steven Waggonner, MD

Robert DeBernardo, MD

Roberto Vargas, MD

Lindsey Beffa, MD

Johanna Kelley, MD

Daniel Margul, MD

Michelle Kuznicki, MD

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Double-blind, placebo-controlled randomized trial

This study is only for biological females

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)

Number of participants who have complete histologic response following topical artesunate ointment

Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.

Number of participants with documented partial response following topical artesunate

Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window

Number of participants who report artesunate-related serious adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of TF002 in Cutaneous Mastocytosis	NCT00457288	Cutaneous Masto...	TF 002	18 Years -	JADO Technologies GmbH
PMS to Evaluate the Safety and Efficacy of Picato® Gel	NCT02421471	Actinic Keratos...	Ingenol mebutat...	19 Years -	LEO Pharma
Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK	NCT05164393	Actinic Keratos...	AVX001	18 Years -	Coegin Pharma AB
Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)	NCT03421912	Head and Neck S... Colorectal Canc... Non Small Cell ... Epidermal Growt...	Cicaplast Balm ... Dexeryl	18 Years -	Centre Leon Berard
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)	NCT06075264	Vulvar Diseases HPV Infection Vulvar HSIL Pre-Cancerous D... HPV Disease VIN, Usual Type VIN 2 of Usual ... VIN 3 of Usual ... Vin II Vin III VIN Grade 2 VIN Grade 3 High Grade Intr...	Artesunate oint... Placebo ointmen...	18 Years -	Frantz Viral Therapeutics, LLC

Spots Global Cancer Trial Database for topical treatment