Neoplasms

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Immune System Diseases

Pilonidal Sinus

Granuloma

Paranasal Sinus Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Cysts

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anesthetics

Ornidazole

Anti-Bacterial Agents

Ampicillin

Antibiotics, Antitubercular

Sulbactam

Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.

Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.

Conservative treatment described as follow:

Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.

postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.

Surgery

this treatment will include conservative procedures under local anesthesia for patient comfort.

conservative

Mehmet KAPLAN, MD

The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the disease. The investigators hypothesise that surgical treatment of UPS will be better than conservative management in terms of recurrence rate, healing time, patient comfort and satisfaction, and cost effectiveness.

Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of diagnosis, etiology, and the best treatment options.

UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and development of a sinus lined with granulation tissue. Most of the patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a careful examination, in which hairs can be seen deep in the umbilicus and usually protrude from a small sinus.

Regarding the optimal treatment of the disease, a complete consensus has not yet been achieved. Some publications are recommended conservative treatment, while surgical treatment is recommended in others.

A more meaningful comparison of the two modalities is that of a randomized controlled trial. We, therefore, present our data of prospective randomized controlled clinical trial comparing conservative versus surgical treatment of UPS.

This was a multicenter, prospective balanced randomization, double blind, active-controlled, parallel-group, superiority study conducted in Turkey, under the direction of a principal investigator (MK). Eligible patients with UPS were randomized for either conservative treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.

Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial

from initial treatment to the complete healing, all kind of cost will be calculated.

Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.

Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy.

the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.

Well-being and satisfaction scales comprised linear metric scales known as "visual analogue scales," with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).

Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Medical Park Gaziantep Hospital

Principal investigator

Conservative treatment described as follow:

Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.

Conservative

Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.

Approximation of the subcutaneous tissue with a single purse-string absorbable suture.

Total

Age, Continuous

Gender

Turkey

Region of Enrollment

Dr. Mehmet Kaplan

Conservative treatment described as follow:

Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.

postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.

conservative: this treatment will include conservative procedures under local anesthesia for patient comfort.

Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed

Cure Rate

Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.

Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.

Surgery: modified umbilectomy

Healing Time

Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.

Visual Analogue Scale for Patient Satisfaction (VAS-PS)

Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.

Costs

Overall Study

Skin and Connective Tissue Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

Imiquimod

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications

Vehicle to nanomedicinal cream (NMC) Twice daily applications

Vehicle to liquid crystal cream (LCC) Twice daily applications

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

Investigational Treatment

Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Active comparator

Novartis Pharmaceuticals

This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.

Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients

A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic Keratosis

Number of participants with at least one AE/SAE in the category up to 20 weeks

Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined

Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined

Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined

Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined

LFX453 0.1% NMC

LFX453 0.15% LCC

Vehicle to NMC

Vehicle to LCC

Aldara

Sex: Female, Male

Study Director

Adverse Events (AEs)

Serious Adverse Events (SAEs)

The safety analysis set included all patients that received any study drug. For Safety \& Tolerability only the 2 vehicles have separate analysis.

Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks

Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications

Combined Vehicle

Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.

Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

Week 8

Week 16

Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined

Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined

Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Papilloma

Sexually Transmitted Diseases

Virus Diseases

Warts

Condylomata Acuminata

Communicable Diseases

Papillomavirus Infections

DNA Virus Infections

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Aldara 5% cream 3 applications per week for a maximum of 16 weeks

The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%.

During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of Topical LFX453 Formulations in Patients With External Genital Warts (EGWs)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Number of participants achieving complete clearance of genital warts at Week 14

Number of participants with at least one AE/SAE in the category up to 30 weeks

Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16

Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.

Complete Clearance of Disease at Week 14

Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks

Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease	NCT01662765	Pilonidal Sinus Sinus; Dermal, ... Umbilical Granu...	Surgery conservative	-	Medical Park Gaziantep Hospital
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease	NCT01662765	Pilonidal Sinus Sinus; Dermal, ... Umbilical Granu...	Surgery conservative	-	Medical Park Gaziantep Hospital
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients	NCT02404389	Actinic Keratos...	Investigational... Active comparat...	18 Years - 75 Years	Novartis
Efficacy and Tolerability of Topical LFX453 for External Genital Warts	NCT02482428	External Genita...	Investigational... Aldara	18 Years - 60 Years	Novartis
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients	NCT02404389	Actinic Keratos...	Investigational... Active comparat...	18 Years - 75 Years	Novartis

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