CLINICAL TRIALS PROFILE FOR SINECATECHINS

All Clinical Trials for SINECATECHINS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02029352 ↗	Topical Green Tea Ointment in Treatment of Superficial Skin Cancer	Completed	Medigene AG	Phase 2/Phase 3	2014-11-01	Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%). A simplified classification of BCC includes the following three histological subtypes: nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs) differ from the other subtypes as they tend to appear at a younger age, usually occur on the trunk and are often multiple. This subtype has the fastest growing incidence. A characteristic feature of BCCs is their low risk to metastasize, though if untreated they may induce considerable functional and cosmetic morbidity as they are locally invasive. Surgery is the first treatment of choice for BCC. However due to the rising incidence and the extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as they grow down from the epidermis into the superficial dermis and therefore are easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or 5-fluorouracil cream are available topical treatments for sBCC however their tumour free survival rates are not equal to the higher tumour free survival rates of surgical treatment. Next to the efficacy, the now available topical treatments are associated with local skin reactions at the treatment site, mainly erythema and erosion (imiquimod cream and 5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for additional or alternative non-invasive topical treatments. The active constituents of green tea are promising as they are supported to have anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies. The so-called polyphenols known as catechins are the active constituents of green tea and the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is thought to have a cytotoxic effect on skin cancer cells and has the availability of inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a role in inactivation of β-catenin signalling, an important component of the WNT pathway. Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the US Food and Drug Administration (FDA) for genital warts in adults. There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo for the topical treatment of sBCCs.
NCT02029352 ↗	Topical Green Tea Ointment in Treatment of Superficial Skin Cancer	Completed	Will-Pharma	Phase 2/Phase 3	2014-11-01	Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%). A simplified classification of BCC includes the following three histological subtypes: nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs) differ from the other subtypes as they tend to appear at a younger age, usually occur on the trunk and are often multiple. This subtype has the fastest growing incidence. A characteristic feature of BCCs is their low risk to metastasize, though if untreated they may induce considerable functional and cosmetic morbidity as they are locally invasive. Surgery is the first treatment of choice for BCC. However due to the rising incidence and the extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as they grow down from the epidermis into the superficial dermis and therefore are easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or 5-fluorouracil cream are available topical treatments for sBCC however their tumour free survival rates are not equal to the higher tumour free survival rates of surgical treatment. Next to the efficacy, the now available topical treatments are associated with local skin reactions at the treatment site, mainly erythema and erosion (imiquimod cream and 5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for additional or alternative non-invasive topical treatments. The active constituents of green tea are promising as they are supported to have anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies. The so-called polyphenols known as catechins are the active constituents of green tea and the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is thought to have a cytotoxic effect on skin cancer cells and has the availability of inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a role in inactivation of β-catenin signalling, an important component of the WNT pathway. Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the US Food and Drug Administration (FDA) for genital warts in adults. There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo for the topical treatment of sBCCs.
NCT02029352 ↗	Topical Green Tea Ointment in Treatment of Superficial Skin Cancer	Completed	Maastricht University Medical Center	Phase 2/Phase 3	2014-11-01	Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%). A simplified classification of BCC includes the following three histological subtypes: nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs) differ from the other subtypes as they tend to appear at a younger age, usually occur on the trunk and are often multiple. This subtype has the fastest growing incidence. A characteristic feature of BCCs is their low risk to metastasize, though if untreated they may induce considerable functional and cosmetic morbidity as they are locally invasive. Surgery is the first treatment of choice for BCC. However due to the rising incidence and the extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as they grow down from the epidermis into the superficial dermis and therefore are easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or 5-fluorouracil cream are available topical treatments for sBCC however their tumour free survival rates are not equal to the higher tumour free survival rates of surgical treatment. Next to the efficacy, the now available topical treatments are associated with local skin reactions at the treatment site, mainly erythema and erosion (imiquimod cream and 5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for additional or alternative non-invasive topical treatments. The active constituents of green tea are promising as they are supported to have anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies. The so-called polyphenols known as catechins are the active constituents of green tea and the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is thought to have a cytotoxic effect on skin cancer cells and has the availability of inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a role in inactivation of β-catenin signalling, an important component of the WNT pathway. Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the US Food and Drug Administration (FDA) for genital warts in adults. There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo for the topical treatment of sBCCs.
NCT02147353 ↗	Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment	Completed	Fougera Pharmaceuticals Inc.	N/A	2011-09-01	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.
NCT02147353 ↗	Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment	Completed	Icahn School of Medicine at Mount Sinai	N/A	2011-09-01	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.
NCT03682601 ↗	Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment	Terminated	GTO Pharmaceutical, LLC	Phase 2	2018-08-30	This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source of pain during sexual contact or dyspareunia, in postmenopausal women, with vulvovaginal atrophy. Women may or may not be using estrogens. Half of the women will receive the study drug, 5 or 10% sinecatechins and half will receive placebo. In addition to the reduction or elimination of pain upon penetration, women may also experience increase in lubrication, arousal and intensity of orgasm
NCT04055142 ↗	Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males	Not yet recruiting	Hospital Universitari Vall d'Hebron Research Institute	Phase 3	2019-09-01	This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males. All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

Clinical Trial Conditions for SINECATECHINS

Condition Name

Condition Name for SINECATECHINS
Intervention	Trials
Arousal Disorders, Sexual	1
Vestibulodynia	1
Carcinoma, Basal Cell	1
Vulvodynia	1

Condition MeSH

Condition MeSH for SINECATECHINS
Intervention	Trials
Vulvodynia	1
Atrophy	1
Vulvar Vestibulitis	1
Warts	1

Clinical Trial Locations for SINECATECHINS

Trials by Country

Trials by Country for SINECATECHINS
Location	Trials
United States	26
Guam	1
Netherlands	1

Trials by US State

Trials by US State for SINECATECHINS
Location	Trials
New York	2
Washington	1
Virginia	1
Texas	1
South Carolina	1

Clinical Trial Progress for SINECATECHINS

Clinical Trial Phase

Clinical Trial Phase for SINECATECHINS
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for SINECATECHINS
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for SINECATECHINS

Sponsor Name

Sponsor Name for SINECATECHINS
Sponsor	Trials
Fougera Pharmaceuticals Inc.	1
Icahn School of Medicine at Mount Sinai	1
GTO Pharmaceutical, LLC	1

Sponsor Type

Sponsor Type for SINECATECHINS
Sponsor	Trials
Other	6
Industry	2
NIH	1

SINECATECHINS Market Analysis and Financial Projection

Sinecatechins: Clinical Trials, Market Analysis, and Projections

Introduction

Sinecatechins, a polyphenolic extract from green tea, have been gaining attention for their therapeutic potential in treating various conditions, particularly those related to human papillomavirus (HPV) and other viral infections. Here, we delve into the recent clinical trials, market analysis, and future projections for sinecatechins.

Clinical Trials Overview

Vulval Intraepithelial Neoplasia (VIN)

Recent clinical trials have focused on the efficacy and safety of sinecatechins in treating vulval intraepithelial neoplasia (VIN), a precancerous condition of the vulva. A Phase II double-blind randomized control trial involving 26 women with VIN compared 10% sinecatechins ointment (Veregen) against a placebo. The trial found that while there was no significant difference in histological response between the two groups, the sinecatechins group showed a statistically significant improvement in clinical response, with all 13 patients experiencing either complete or partial clinical resolution of VIN lesions[1][4].

Safety and Symptom Improvement

The trials indicated that sinecatechins were safe to use, with most side effects being mild and transient. The treatment also improved quality of life and reduced symptoms of pain in the patients treated with Veregen cream[1][4].

External Genital Warts (EGW)

In addition to VIN, sinecatechins have been evaluated for their efficacy in treating external genital warts (EGW). Studies have shown that sinecatechins offer a higher sustained clearance rate compared to imiquimod, another commonly used treatment, and are associated with lower treatment costs[5].

Market Analysis

Global HPV and CMV Therapeutics Market

The global market for HPV and cytomegalovirus (CMV) therapeutics is projected to reach $6.5 billion by 2031, growing at a CAGR of 6.5%. The HPV therapeutics segment, which includes sinecatechins, is expected to dominate the market due to the increasing prevalence of HPV infections worldwide. Within the HPV therapeutics market, the segment for immunomodulators, such as imiquimod and interferon alpha-2b, currently holds the largest share, but the sinecatechins segment is predicted to grow at the fastest rate during the forecast period[2].

Cost-Effectiveness

Sinecatechins have been shown to be more cost-effective than other treatments like imiquimod. A cost-effectiveness analysis revealed that sinecatechins yield a lower cost of treatment with a higher sustained clearance rate, offering significant cost savings to healthcare systems[5].

Market Projections

Growth Drivers

The growth of the sinecatechins market is driven by several factors:

• Increasing Prevalence of HPV: The rising incidence of HPV infections, particularly in developing and underdeveloped regions, is a significant driver.
• Demand for Low-Cost Treatments: The need for affordable and effective treatments for viral infections is increasing, and sinecatechins fit this criteria.
• Clinical Efficacy: The demonstrated safety and efficacy of sinecatechins in clinical trials are bolstering their market position[2].

Segment Growth

The sinecatechins segment is expected to grow rapidly due to its superior efficacy and safety profile compared to other treatments. This growth will be further supported by ongoing research and the potential for larger, multicenter studies to confirm the initial positive results[1][4].

Future Outlook

Expanded Clinical Trials

Given the promising results from Phase II trials, there is a strong case for conducting larger, Phase III clinical trials to further establish the efficacy and safety of sinecatechins in treating VIN and other HPV-related conditions. These trials will be crucial in solidifying the market position of sinecatechins and expanding their therapeutic applications[1][4].

Regulatory Approvals

As more data becomes available from ongoing and future clinical trials, regulatory approvals are likely to be sought and granted, further expanding the market reach of sinecatechins.

Competitive Landscape

Sinecatechins are poised to become a significant player in the HPV therapeutics market, competing with established treatments like imiquimod and podophyllotoxin. Their unique profile of being more effective and safer than some existing treatments positions them favorably in the market[2].

Key Takeaways

• Clinical Efficacy: Sinecatechins have shown promising results in treating VIN and EGW, with significant clinical response rates and symptom improvement.
• Safety Profile: The treatment is safe with minimal side effects, making it a viable option for patients.
• Cost-Effectiveness: Sinecatechins offer lower treatment costs compared to other therapies, providing cost savings to healthcare systems.
• Market Growth: The sinecatechins segment is expected to grow rapidly due to increasing demand for effective and affordable HPV treatments.
• Future Trials: Larger clinical trials are necessary to further establish the efficacy and safety of sinecatechins, potentially leading to expanded therapeutic applications.

FAQs

What is the current status of sinecatechins in clinical trials?

Sinecatechins have completed Phase II clinical trials for treating VIN and EGW, showing promising results in terms of safety and efficacy.

How does sinecatechins compare to other HPV treatments?

Sinecatechins are more effective and safer than some existing treatments like imiquimod and podophyllotoxin, and they offer lower treatment costs.

What is the projected market size for HPV and CMV therapeutics by 2031?

The global market for HPV and CMV therapeutics is projected to reach $6.5 billion by 2031, with the HPV therapeutics segment expected to dominate.

What are the main drivers of the sinecatechins market growth?

The growth is driven by the increasing prevalence of HPV infections, demand for low-cost treatments, and the demonstrated clinical efficacy and safety of sinecatechins.

Are there any ongoing or planned larger clinical trials for sinecatechins?

Yes, larger, multicenter Phase III clinical trials are anticipated to further establish the efficacy and safety of sinecatechins in treating VIN and other HPV-related conditions.

Sources

1. PubMed: Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study.
2. iHealthcareAnalyst: Global HPV and CMV Therapeutics Market $6.5 Billion by 2031.
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. Cancer Research UK: A trial of Veregen cream for women with vulval intraepithelial neoplasia (EPIVIN).
5. PubMed: A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts.