Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

(group A): thirty patients will be treated by application of carbon dioxide laser.

(group B): thirty patients will be treated by cryotherapy application.

Carbon dioxide laser

Cryotherapy

Nagwa Essa, PD

Hanan Ahmed, MD

Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.

A range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved.

These include:

* Common wart (Verruca vulgaris).
* Flat wart (Verruca plana).
* Filiform or digitate wart.
* Genital wart (venereal wart, Condyloma acuminatum, Verruca acuminata).
* Mosaic wart.
* Periungual wart.
* Plantar wart (verruca, Verruca plantaris). Despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. Viral warts often disappear without treatment. In case of pain, discomfort and long duration they can be treated . Treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery.

Common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. Published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. Mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. Frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. Vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. Haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. Hairpin vessels were usually seen in non-wart lesions.

In this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.

Carbon Dioxide Laser and Cryotherapy in Treatment of Warts

Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart

Assiut University

Principal Investigator

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

Papilloma

Respiratory Tract Infections

Disease Attributes

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Recurrent Respiratory Papillomatosis

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Anti-Inflammatory Agents

Analgesics

Gastrointestinal Agents

Micronutrients

Hematinics

Other Dietary Supplements

Vitamins

Bevacizumab

Methotrexate

Acyclovir

Celecoxib

Isotretinoin

Interferons

Tretinoin

Interferon-alpha

Interferon-alfa-1b

Artemisinins

Artemisinin

Cimetidine

Cidofovir

Indole-3-carbinol

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Antacids

Anti-Ulcer Agents

Histamine

Histamine H2 Antagonists

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Cytochrome P-450 Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Protective Agents

Indole

Folinic Acid

Folate

Vitamin B9

Microdebrider

Cold-steel surgery (forceps)

Removal of lesions via carbon dioxide laser

Potassium titanyl phosphate (KTP) laser

Pulsed dye laser

Removal of lesions via radiofrequency ablation

Radiofrequency ablation

Removal of lesions via monopolar suction diathermy

Monopolar suction diathermy

Removal of lesions via plasma coagulation

Plasma coagulation

Other

Adjuvant therapies

Andrew Sims

Adam Donne

Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment.

Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.

Primary aim:

The overall goal is to improve the care of patients with Recurrent Respiratory Papillomatosis (RRP) - and the investigators aim to do this by determining the most effective and safe RRP treatments currently being used in patients in National Health Service (NHS) hospitals within the United Kingdom (UK) (information which is currently lacking).

By determining the most effective treatments of RRP, the investigators will be able to increase the time interval between surgical interventions to maintain symptomatic control, reduce overall number of RRP interventions, severity and spread of papillomas in the airway, hospital visits, medications and ultimately improve quality of life in those suffering from RRP. By also capturing peri- and post-procedural details the investigators will be able to determine the relative safety of treatments and identify those which slow the progression of disease.

From the data collected the investigators intend to identify patient subgroups (based on patient characteristics such as age, gender, human papillomavirus (HPV) type, location of papillomas, RRP severity and spread, comorbidities) who respond better to specific treatments, and also identify patient risk factors which contribute to the complication outcomes (such as tracheostomy).

Secondary aims:

* build an evidence base of the different RRP treatments used across the UK which will help to formulate hypotheses for future research in RRP and improve quality of life for RRP patients;
* inform National Institute for Health and Care Excellence (NICE) interventional procedure guidance on radiofrequency cold ablation (IPG434,2012), which is currently under special arrangements due to lack of safety and efficacy evidence;
* identify common symptoms or signs associated with RRP disease profile, to aid future diagnosis of RRP;
* determine the geographical spread of RRP patients across the UK, to inform effective use of future NHS resources and inform the Department of Health strategy in its quadrivalent HPV vaccination programme (protecting against four types of HPV including types 6 and 11 commonly associated with RRP) currently offered to 12-13 year old girls within the NHS childhood vaccination programme;
* inform future development of national clinical guidance on management of RRP to ensure that everyone receives the best care based on best available current knowledge;
* determine impact of COVID on RRP patients including changes to RRP management, RRP symptoms.

Objectives:

The investigators will make use of an existing secure online database platform (the Airway Intervention Registry, AIR - developed and hosted by The Newcastle upon Tyne Hospitals NHS Foundation Trust, NUTH) and its associated infrastructure and develop it to capture additional observational outcomes from standard clinical practice and quality of life questionnaires from RRP patients. All RRP patients (any age) receiving treatment in any UK NHS hospital will be eligible for inclusion. Data collection will be open for 53 months with no minimum follow-up required for patients. Due to its recurrent nature (requiring regular hospital visits to maintain an open airway), following this patient population will allow the investigators to determine both the short- and long-term relative safety and efficacy of RRP treatments used in the UK. Consent will be required (from patients/parent/guardian) before data are entered into the online database.

Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)

Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis

Patients will be informed that all data collected will be used for research purposes, no patient identifiable information will be shared with external parties for commercial purposes, patient identifiable information will only be accessible by clinicians at their treating organisation, pseudonymised data will be accessed by study analysts, and that only anonymised high-level aggregate data will be shared with other centres to update participating centres of study progress and data completeness issues. Patients will also be informed that any external researchers requesting data from the registry will be required to submit a formal application form and evidence of appropriate ethical approvals in place for review by the Steering Group. If approval is given, only anonymised data will be shared for the purposes of external research studies.

Time between surgical interventions to maintain symptomatic control

Measured via Derkay severity score (higher score corresponding with higher severity; clinical score range 0-11, anatomical score range 0-75, summed total score range 0-86)

Inpatient, Accident \& emergency, Outpatient

Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)

Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)

Planned discharge location (decided pre-operation)

Actual discharge location (occurring post-operation)

Unexpected hospital, Accident \& emergency (A\&E), General Practitioner (GP) attendances due to RRP symptoms.

Test results, antibody results, symptoms, changes to management,

Alder Hey Children's NHS Foundation Trust

National Institute for Health Research, United Kingdom

Newcastle-upon-Tyne Hospitals NHS Trust

Carcinoma

Skin Neoplasms

Carcinoma, Basal Cell

Bowen's Disease

Neoplasms, Basal Cell

Carcinoma, Squamous Cell

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Vasoconstrictor Agents

Respiratory System Agents

Lidocaine

Anesthetics

Epinephrine

Anesthetics, Local

Aminolevulinic Acid

Racepinephrine

Epinephryl borate

Methyl 5-aminolevulinate

Sodium Channel Blockers

Diuretics, Potassium Sparing

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Photosensitizing Agents

The treatment starts with a full ablative CO2 laser pretreatment under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with a LED lamp. This treatment is repeated after 14 days.

The treatment starts with a fractional ablative CO2 laser ablation under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with LED lamp. This treatment is repeated after 14 days.

ablation to the level of de dermal papilla

full ablative CO2 laser

180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)

fractional ablative CO2 laser

LED lamp

lidocaine hydrochloride 2% with epinephrine

Barbara Boone, MD PhD

Photodynamic therapy (PDT) is a well established treatment option for superficial non melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD). However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of this photosensitizer. This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Superficial Basal Cell Carcinoma (sBCC) and Bowen Disease (BD) are malignant skin tumors localised in the superficial epidermis. These tumors are highly prevalent in the caucasian population. Diagnosis of sBCC and BD is often delayed because the clinical manifestation may be discrete and lesions are sometimes wrongly diagnosed and treated as eczema. Once the diagnosis is established, the lesions may cover an extensive area, making surgical excision more difficult. At that moment, the physician can make use of less invasive techniques such as photodynamic therapy (PDT). Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of the photosensitizer methyl aminolevulinate (MAL). This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. Ablation of the upper epiderm of the cancer results in an deeper penetration of MAL. Fractional ablation is known to result in better wound healing compared to full ablative CO2 laser ablation, because only small skin columns are ablated instead of the entire epidermal layer. Patients with non operable sBCC or BD lesions covering an area of at least 5 cm2 or with the presence of two small separated lesions, will be investigated. Lesions greater than 5 cm2 are divided in two. After randomization, the half of the lesions will be pretreated with the full ablative CO2 laser, while the other half with the fractional ablative CO2 laser. Afterwards, the entire surface is treated with MAL-PDT. Such as in our current clinical practice, this treatment modality is repeated after a two week interval. Thus, every subject undergoes both treatment modalities, making within-patient comparison possible. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial

A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer

A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.

The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.

The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.

The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.

The aesthetic result is scored by a blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).

The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).

The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).

Patients are asked for their preferred therapy. Following options exist: (1) full ablative CO2 laser + PDT, (2) fractional ablative CO2 laser + PDT, (3) no preference

University Hospital, Ghent

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbon Dioxide Laser and Cryotherapy in Treatment of Warts	NCT03166137	Common Warts	Carbon dioxide ... Cryotherapy	-	Assiut University
Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)	NCT03465280	Recurrent Respi... Human Papilloma...	Microdebrider Cold-steel surg... Carbon dioxide ... Potassium titan... Pulsed dye lase... Radiofrequency ... Monopolar sucti... Plasma coagulat... Other Adjuvant therap...	-	Newcastle-upon-Tyne Hospitals NHS Trust
Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial	NCT03012009	Bowen's Disease Superficial Bas...	full ablative C... fractional abla... MAL LED lamp lidocaine hydro...	18 Years -	University Hospital, Ghent
Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)	NCT03465280	Recurrent Respi... Human Papilloma...	Microdebrider Cold-steel surg... Carbon dioxide ... Potassium titan... Pulsed dye lase... Radiofrequency ... Monopolar sucti... Plasma coagulat... Other Adjuvant therap...	-	Newcastle-upon-Tyne Hospitals NHS Trust

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