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

Anti-Infective Agents

Dermatologic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Salicylic Acid

Salicylates

Clotrimazole

Miconazole

Antifungal Agents

Keratolytic Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients in this Group were subjected to Cryotherapy Alone with liquid nitrogen and received maximum of four treatments given two to three weeks apart

Patients in this Group were subjected to cryotherapy plus salicylic acid for a maximum of eight weeks

Patients in Group A were subjected to Cryotherapy Alone with liquid nitrogen and received maximum of four treatments given two to three weeks apart .

The liquid nitrogen was applied with a spray or a probe

Cryotherapy Alone

Patients in Group B were subjected to cryotherapy plus with 50% salicylic acid to be properly applied for a maximum of eight weeks The liquid nitrogen was applied with a spray or a probe

Cryotherapy plus Salicylic Acid

Verrucae plantaris (plantar warts) are a frequent cutaneous lesion of the plantar portion of the foot caused by the human papillomavirus (HPV) (HPV).Although HPV is ubiquitous in our environment, cellular and humoral immune responses typically prevent it from spreading or eliminate it.

Warts can be painful and can lead to other difficulties, but there are some populations that are at a higher risk of getting HPV because they encounter the virus more frequently.

In addition to infecting other people, HPV can also spread to other locations in the area. While reducing exposure to risk factors can help prevent plantar wart infection, HPV's widespread nature makes it difficult for such efforts to be effective.

It has been shown in research that plantar warts can spread from person to person through just physical contact with the sores. Warts are more common in people with HPV because the virus disrupts the epithelial barrier. There are over a hundred different forms of the HPV virus, so even though some warts go away on their own after a few years, others may need medical attention.

Warts, according to a number of studies, are extremely common (affecting around 10% of the population) all over the world. More cases of HPV infection have been observed among people under the age of 30, compared to those beyond the age of 30. The estimated prevalence in the United States is between 10% and 20%. However, people with compromised immune systems and those who work with meat are disproportionately at risk.

The cancerous transformation of warts is quite rare. Even while verrucous carcinoma, a malignant form of wart development, is possible, it seldom spreads and only causes localised tissue loss.

Plantar warts are treated in a manner that takes into account the patient's symptoms, personal preferences, and financial situation. Even though there are several therapy options, none of them are particularly effective, and relapses are common after any treatment. As a result, the most accessible and least distressing treatment option should be prioritised.

Since salicylic acid can be used by the patient at home and does not require a doctor's prescription, it is often regarded a first-line therapy for the common wart. It can be as high as 70% effective in curing the disease. Other effective therapies for plantar warts include cryotherapy, retinoic acid, podophyllin, topical 5-fluorouracil, interferon, and imiquimod.

Salicylic acid, in conjunction with cryotherapy, has shown therapeutic efficacy in patients with only foot warts, according to a single prior study. Patients who were given cryotherapy in this trial had a 58% success rate at recovery, whereas those given salicylic acid had a 41% success rate. Hover, there is no discernible statistical difference.

The purpose of this study was to compare the effectiveness of cryotherapy alone against cryotherapy plus salicylic acid dressing for planter warts, keeping in mind the prevalence of treatment for plantar warts and the lack of a well-established, practically applicable, and reliably preventative method in our local population.

Comparative Study Between Treatment With Cryotherapy Alone Versus Cryotherapy Plus Salicylic Acid Dressing for Planter Warts

effectiveness assesed by %clinical improvement=(present % tissue distruction + baseline % tissue destruction)100

Combined Military Hospital Abbottabad

principal investigator

Condylomata Acuminata

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Cryotherapy and then Sinecatechins 15% Ointment 1 week later.

Cryotherapy will be standardized in all subjects and for all treated lesions: EGW lesions will be treated with 2 sprays, 5 seconds each, with a 5 second interval. All subjects will be treated with the same cryo-spray regimen.

Following cryotherapy, half of the subjects will be randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy (Week 1).

Sinecatechins 15% Ointment

Cryotherapy will be standardized in all subjects and for all treated lesions.

Cryotherapy alone

Gary Goldenberg, MD

External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.

A total of 42 subjects received standardized cryotherapy to all lesions, using two cycles of five seconds each, separated by a five second interval rest (Week 0/Baseline). One week following cryotherapy, subjects were randomized 1:1 to either additional treatment with sinecatechins 15% ointment twice daily or no additional treatment. Those subjects randomized to additional treatment received sinecatechins 15% ointment BID for up to sixteen weeks, or until complete clearance of all EGW, whichever occurred first. Additionally, subjects were advised to maintain safe sexual practices and have all recent sexual partners examined for EGW. Subjects were followed every 8 weeks for a total of 16 weeks (Table 1). EGW lesion counts were conducted at all study visits by the same qualified blinded evaluator. Additionally, at each visit local skin reactions, change in concomitant medications, and adverse events were assessed. Any subjects who received sinecatechins 15% ointment and discontinued prematurely were asked to return for an End of Study Visit. Females of childbearing potential underwent a urine pregnant test at all visits during study treatment period. Subjects that met complete responder criteria as above, were additionally followed and assessed at Visit5/Week 41 and Visit 6/Week 65 to assess for wart recurrence.

Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment

An Investigator-Initiated Study to Assess the Safety and Efficacy of Sinecatechins 15% Ointment When Used in Conjunction With Cryotherapy in the Treatment of External Genital Warts

Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.

To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 24 week post-treatment period.

To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 48 week post-treatment period.

To evaluate the safety of cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone as a regimen for EGW by evaluating for local skin reactions and adverse events.

Number of participants with local skin reactions.

Partial clearance is described as at least 50% reduction from baseline

Mean change in number of lesions after 1 weeks, 9 weeks and 17 weeks post treatment as compared to baseline

Mean change in number of lesions as compared to baseline at Week 1, Week 9 and Week 17 for the intent-to-treat population

Fougera Pharmaceuticals Inc.

Icahn School of Medicine at Mount Sinai

Assistant Professor

There were no serious adverse events related to the study medication reported during the study. All subjects experienced mild to moderate local site reactions (eg, any symptom of erythema, edema, scaling, crusting, and erosion which were not collected separately) that were related to both cryotherapy and/or sinecatechins ointment. There were no subject discontinuations or dose interruptions.

Cryotherapy and then Sinecatechins 15% Ointment 1 week later.

Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.

Sinecatechins 15% Ointment & Cryotherapy

Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.

Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparative Study Between Treatment With Cryotherapy Alone Versus Cryotherapy Plus Salicylic Acid Dressing for Planter Warts	NCT05588999	Plantar Wart	Cryotherapy Alo... Cryotherapy plu...	15 Years - 40 Years	Combined Military Hospital Abbottabad
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment	NCT02147353	External Genita...	Sinecatechins 1... Cryotherapy alo...	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for cryotherapy alone