Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Anesthetics

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Standard surgical "elliptical" excision including a 3-mm clinically tumour-free margin according to the current local hospital arrangements.

Tumours will be partially debulked under local anaesthesia by removing all tumour tissue until normal dermis remains with a blunt curette. After curettage patients will receive an instruction sheet to apply imiquimod 5% cream once daily, 5 days a week, during 6 weeks, starting one week after the curettage procedure. Patients will be instructed to apply a thin layer to the tumour including 5-10mm of the surrounding skin at least 1 hour before going to bed at night. The lesion will not be covered (unless needed because of weeping or bleeding). Participants will be asked to wash their hands after applying the cream, and to wipe the cream off after 8 hours (in the morning).

Imiquimod 5% cream with prior curettage

Standard surgical excision

Klara Mosterd, MD, PhD

Basal cell carcinoma (BCC) is a slow-growing, locally invasive malignant epidermal skin tumour. It is the most common malignant disease in Caucasians, representing approximately 80% of all cases of skin cancer and is therefore an important health problem. In the Netherlands incidence rates are 165 for men and 157 for women per 100.000 person-years, and these rates are rising with 3-10% every year.

A simplified histological classification of BCCs includes the following three subtypes: nodular, superficial and infiltrative variants, with the nodular variant being the most frequent type. Although a characteristic feature of BCCs is their low risk to metastasize, if untreated they may be locally invasive and may induce considerable functional and cosmetic morbidity.

The gold standard treatment of all histological BCC subtypes is surgical excision (SE), but not all patients are eligible for surgery. In patients with multiple BCCs and older patients, surgery may lead to significant morbidity, and in some cases, it may result in disfiguring scarring. For these reasons and to reduce workload and costs in the healthcare system, there is a growing demand for alternative, non-invasive, treatments. An advantage of non-invasive treatment options is that they can be performed by other healthcare professionals, such as general practitioners and specialized nurses. For treatment of superficial BCCs (sBCC) non-invasive treatments, such as topical imiquimod (IMQ), 5-fluorouracil (5-FU) or photodynamic therapy (PDT) are already commonly used. Our group investigated the efficacy of those three therapies and found that after 3 years, BCCs treated with IMQ had a significant lower risk of recurrence, compared to the other therapies.

A recent study suggests that IMQ, besides being an immune-response modifier, also directly inhibits sonic hedgehog (SHH) signalling, the most important pathway active in BCCs. This targeted effect of IMQ very likely explains the superior therapeutic effect. Treatment of nodular BCC (nBCC) with IMQ has been investigated. Without prior curettage, high efficacy rates were found, although efficacy was still slightly inferior to SE.

The investigators hypothesize that the effectiveness of IMQ following prior curettage will not be inferior to SE and that the benefits will be a higher patient satisfaction and lower healthcare costs. A recently published discreet choice experiment showed that patients preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment.

Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma

Surgical Excision Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma: an Open, Non-inferiority, Randomized Controlled Trial

Baseline characteristics (ie. age, sex, amount of sun-exposure, size and localisation of the target tumour, medical history and concomitant medication) will be recorded.

The primary study endpoint is the proportion of participants tumour-free at 1 year after end of treatment (defined as absence of initial treatment failure or any clinical signs of local recurrence). For SE, routine histological examination of haematoxylin and eosin (H\&E)-stained sections of the lateral and deep margins will be used to assess treatment failure. For curettage \& IMQ 5% cream, initial treatment failure will be clinically assessed at a follow-up visit 3 months after end of treatment. Initial treatment failure or any clinical signs of subsequent local recurrence will be assessed and recorded separately by one investigator. In case there is clinical suspicion of BCC, a 3 mm punch biopsy will be taken for histological verification.

Any clinical signs of subsequent local recurrence will be assessed by one investigator. In case there is clinical suspicion of BCC, a 3 mm punch biopsy will be taken for histological verification.

Data for compliance with the prescribed regimens of IMQ 5% cream will be obtained from a personal diary kept by patients and completed daily during the six week IMQ 5% application period in subjects allocated to treatment with IMQ. Compliance will be calculated as the number of applications actually applied by the patient divided by the total prescribed number of cream applications. Furthermore sachets will be collected and counted by the investigator. This is a separate compliance assessment. The number of returned sachets will be divided by the total prescribed number of sachets. During the phone consultation by the investigator two weeks after start of application, treatment will be evaluated to ensure continuation of treatment.

Cosmetic appearance of lesion site will be assessed independently by the participant and two independent investigators at 1 and 5 year follow-up using a Dutch four point scale and the Patient and Observer Scar Assessment Scale (POSAS).

Patient satisfaction will be assessed by the participant at 1 and 5 year follow-up on the basis of 3 statements. For the extent of agreement a 4-point rating scale is used, ranging from total disagreement to total agreement

The proportion of patients experiencing a moderate or more severe level of pain. In the IMQ 5 % group, this will be measured daily during the application period and 2 weeks after end of treatment. In the SE group, pain during SE procedure will be measured and pain until the removal of the stiches will be measured daily. Furthermore pain will be measured at the time of removal of the stiches. Pain will be assessed using a 10 cm Visual Analogue Scale (VAS) where 0 represents 'no pain' and 10 represents, 'most severe pain imaginable'.

Data regarding resource use, i.e. outpatient visits, phone consultation, curettage, IMQ cream, SE and potential treatment of side-effects/adverse events will be recorded during the trial. Cost-prices will be derived from the manual for cost research in economic evaluations, the Pharmacotherapeutic Compass and the university hospital Maastricht. If necessary, cost-prices will be calculated based on real resource use. Total treatment costs will be estimated by multiplying volumes of use with the costs per unit. The cost-effectiveness ratio will be expressed as the incremental costs per additional tumour free patient. To quantify the uncertainty surrounding the incremental cost-effectiveness ratio (ICER) bootstrap analysis will be performed. Results of this analysis will be presented in cost-effectiveness planes and acceptability curves.

Adverse events, including local skin reactions, will be collected from all patients up to the 3 months follow-up visit and during phone consultation by the investigator (after two weeks of treatment in the IMQ group and during phone consultation about the histological examination of the excision specimen in the SE group). In case of an extra (phone) consultation of the patients as a result of severe adverse reactions, this will also be recorded. Serious events related to the investigative treatments (SUSAR) will be recorded during the entire follow-up period.

Maastricht University Medical Center

Skin and Connective Tissue Diseases

Keratosis, Actinic

Keratosis

Keratosis, Seborrheic

Skin Diseases

Precancerous Conditions

One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.

One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage.

cryosurgery

the lesion will be anesthetized and destroyed with a curette.

Curettage

Lance D. Wood, M.D.

Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.

The investigators are conducting this study to see which of these two treatments has the best result.

Approximately 24-30 people will take part in this research study at the Hershey Medical Center.

Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?

Follow up evaluation by a blinded physician along with the gathering of patient information via questionnaires will be obtained at the completion of the study.

Milton S. Hershey Medical Center

Symptoms and General Pathology

Recurrence

Clinical or histologic diagnosis of nodular BCC

Clinical or histologic diagnosis of superficial BCC

Curettage without subcutaneous tissue using a 7 mm ring curette and the "fountain-pen technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm.

12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved.

Deep excision

Shave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved.

Shave excision

Curettage with a 7 mm ring curette with the "potato-peeler technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining.

Helmut Breuninger, M.D.

Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision.

This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.

1. First presentation of a patient with clinical or histopathological diagnosis of BCC
2. Study patient number, first and surname, date of birth and gender are listed in a distinct file.
3. Informed consent
4. Whole body screening for skin cancer
5. In- or exclusion of the patient. If the patient is excluded, no more data are obtained.
6. Recording of the following features in an electronic file:

   1. Number of BCCs
   2. Anatomic location

      * Lip
      * Eyelid
      * Ear
      * Nose
      * Other parts of the face
      * Scalp or neck
      * Trunk
      * Arm, hand, or shoulder
      * Leg, foot, or hip
   3. Position

      * Ventral or dorsal. If the tumor is located at the lateral margin of ventral and dorsal, it is considered ventral.
      * Right, left, midline
      * Distinct BCCs are numbered. To ensure future distinction of different tumors, numbering starts with the most up-right-ventral tumor and ends with the most down-left-dorsal one. Numbering continues with BCCs that appear later during the period of recruitment.
   4. Diameter in mm
7. In- or exclusion of the tumor
8. Photographs of the included BCCs
9. Randomization is performed by the Department of Biostatistics (distance to the Department of Dermatology = 1.7 km) with envelopes containing the assigned study arm. The study physician calls one of four staff members of the Department of Biostatistics and asks for randomization. The envelopes are not opened unless the electronic data file is completed by the study physician.
10. Disinfection
11. Local anesthesia
12. Surgery
13. Dressing
14. If histopathology discovers another BCC type than nodular or superficial or even another tumor than BCC, then the tumor is excluded.
15. Follow-up visit 3 and 6 months (+/- 30 days) after the operation. In BCCs that had to be operated in \>1 step, the day of the follow-up visit refers to the initial operation.
16. In case of clinical suspicion of recurrence of BCC a punch biopsy is taken. If the biopsy confirms recurrence, the endpoint is achieved.
17. If BCCs must be added to a patient during the recruitment period, follow-up visits always refer to the latest BCC.
18. If the patient visits our department not within the defined follow-up period, the appointment is not recorded (except confirmation of recurrence).
19. Patients who provide no feedback receive phone calls.
20. If a patient or a private practitioner suspect a recurrence of BCC beyond a defined follow-up period, of course, the patient is invited as early as possible to our department, where a biopsy will be taken.
21. The patient receives a letter containing a list of the BCCs treated within the study. The private practitioner is to be visited with the list after 12, 24, and 36 months (+/- 30 days) referring to the last operation within the recruitment period. The letter contains a questionnaire about scar size and suspicion of recurrence of BCC. The practitioner or the patient return the questionnaire with the answers to our department. If recurrence is suspected we take a biopsy.
22. When follow-up is closed for an individual patient, the reason is recorded:

    1. Planned end of follow-up after 48 months.
    2. Patient has moved.
    3. Death (date of death).
    4. Consent withdrawn.
    5. Patient has become meanwhile so ill or high-maintenance that no more follow-up visits can be planned.
    6. Recurrence of all of the patient's BCCs.
23. Statistic evaluation is based on an intention-to-treat-analysis.
24. The trial is designed to prove the equivalence of treatment modalities. A statistic test is used for evaluation, including the Kaplan-Meier-method. When all 4 study arms contain 116 BCCs, a 2-group-test on the equivalence of ratios with a 1-sided significance level of 0.05 will have a power of 80% to disprove the null hypothesis. The null hypothesis is that standard and test method are not equivalent (ratio difference delta T - delta S ≥ 0.15). Then the alternative hypothesis is more probable, meaning that the ratios in both groups are equivalent supposed that the expected ratio difference is 0.07 and the ratio within the standard group is 0.03 (according to an expected recurrence rate of 3% in the surgical excision study arm).

Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

University Hospital Tuebingen

Professor Helmut Breuninger, MD

Facies

Facial Dermatoses

Anti-Arrhythmia Agents

Channel Blockers

Vasoconstrictor Agents

Respiratory System Agents

Lidocaine

Epinephrine

Racepinephrine

Epinephryl borate

Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.

Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.

Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.

One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.

Pulsed dye laser

A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.

A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

Electrodesiccation

A fourth lesion will not be treated and will serve as a control.

No treatment

Daniel Eisen, M.D.

DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of seborrheic keratoses, predominantly on the face.

The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions off) and electrodesiccation (burning the lesions off).

Dermatosis Papulosa Nigra

Efficacy of a 585 nm Pulsed Dye Laser (PDL) for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.

The physician assessed evidence of hypopigmentation.

The physician assessed evidence of hyperpigmentation.

The physician assessed evidence of texture irregularities.

The physician assessed percent clearance of all treated lesions and the control lesion.

University of California, Davis

No serious and/or other (non-serious) adverse events were observed.

10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.

Pulsed Dye Laser

10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.

10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.

No Treatment

10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.

Study Arm

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Percent Clearance of All Lesions

Evidence of Hypopigmentation

Evidence of Hyperpigmentation

Evidence of Scar

Evidence of Texture Irregularities

Overall Study

No curettage

Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present study aimed to evaluate whether daylight-PDT without curettage would reduce treatment effect compared to daylight-PDT with curettage.

Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

Complete lesion response rate, was defined as the number of completely responding lesions divided by the total number of treated lesion in each field. Complete lesion response was defined as complete disappearance of the lesion both by palpation and visually.

Bispebjerg Hospital

Principal investigator, MD, PhD

Imiquimod cream

curettage and cautery

Robert Herd, Consultant Dermatologist

Areti Makrygeorgou, Staff Grade Dr

Lorna MacKintosh, Specialist Registrar

The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.

Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C\&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C\&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C\&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.

A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base

NHS Greater Glasgow and Clyde

Glasgow Western Infirmary

University of Glasgow

imiquimod

Phillip M Williford, MD

To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma	NCT02242929	Nodular Basal C...	Imiquimod 5% cr... Standard surgic...	18 Years - 90 Years	Maastricht University Medical Center
Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma	NCT02242929	Nodular Basal C...	Imiquimod 5% cr... Standard surgic...	18 Years - 90 Years	Maastricht University Medical Center
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?	NCT01159860	Seborrheic Kera...	cryosurgery Curettage	18 Years - 75 Years	Milton S. Hershey Medical Center
Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma	NCT02242929	Nodular Basal C...	Imiquimod 5% cr... Standard surgic...	18 Years - 90 Years	Maastricht University Medical Center
Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas	NCT00515970	Carcinoma, Basa...	Curettage Deep excision Shave excision Curettage	-	University Hospital Tuebingen
Dermatosis Papulosa Nigra	NCT00710203	Facial Dermatos... Seborrheic Kera...	Pulsed dye lase... Curettage Electrodesiccat... No treatment	18 Years -	University of California, Davis
Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas	NCT00515970	Carcinoma, Basa...	Curettage Deep excision Shave excision Curettage	-	University Hospital Tuebingen
Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas	NCT00515970	Carcinoma, Basa...	Curettage Deep excision Shave excision Curettage	-	University Hospital Tuebingen
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage	NCT03697590	Keratosis, Acti...	No curettage Curettage	18 Years -	Bispebjerg Hospital
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage	NCT03697590	Keratosis, Acti...	No curettage Curettage	18 Years -	Bispebjerg Hospital
A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base	NCT00463359	Basal Cell Carc...	Imiquimod cream curettage and c...	49 Years - 89 Years	University of Glasgow
Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage	NCT00314756	Basal Cell Carc...	imiquimod	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for curettage

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

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