sinecatechins
Regulatory sources consulted
Approved indications
- Treatment of external genital and perianal warts in immunocompetent patients 18 years of age and older.
Clinical warnings
- For external use only. Do not use on the urethra, vagina, cervix, rectum, anus, mucous membranes, or open wounds; avoid sun or ultraviolet exposure of the treated area. — DailyMed/openFDA, SPL set ID f0fc1e21-e3cf-4bce-860c-307f670b192e
- Major warning · Safety and effectiveness have not been established in immunosuppression, beyond 16 weeks, or for multiple courses. Monitor for phimosis and severe local inflammation. — DailyMed/openFDA, SPL set ID f0fc1e21-e3cf-4bce-860c-307f670b192e
- The ointment may weaken condoms and diaphragms; remove it before sexual activity. — DailyMed/openFDA, SPL set ID f0fc1e21-e3cf-4bce-860c-307f670b192e
Adverse events
Common (≥1%)
Local erythema, pruritus, burning, pain, erosion or ulceration, edema, induration, or vesicles
Rare but serious
Severe local pain or inflammation
Pregnancy and lactation
Pregnancy data are insufficient; assess benefit and risk. During breastfeeding, there are no milk or infant data, although plasma exposure after topical use is low; consider the benefits of breastfeeding, the mother’s need, and potential effects.
Recent literature (PubMed)
The present guidelines aim to provide comprehensive information on genital condyloma acuminata, including the epidemiology, clinical features, diagnosis and management. The guidelines provide evidence-based recommendations on the diagnosis, prevention and treatment of genital condyloma acuminata in adults in Asia, including patients with HIV co-infection. A PubMed search was performed, using the keywords "condyloma acuminata", "anal wart", "anogenital wart", "genital wart" and "genital HPV". A total of 3031 results were found in publications during last six years. A careful review of the titles and abstracts was done to find all the studies pertaining to epidemiology, clinical features, diagnosis, treatment and prevention of condyloma acuminata. Various diagnostic procedures described are: 1. PCR (LE: 2b). 2. Serology (LE: 2b). 3. In-situ hybridization (LE: 3). 1. Vaccination (LE: 1a): Quadrivalent vaccine reduced the frequency of anogenital warts in both vaccinated and unvaccinated contacts. According to the update Advisory Committee on Immunization Practices (ACIP) recommendations, the following protocol is recommended: (a). HPV vaccination at age 11 or 12 years for both males and females. (b). Catch-up vaccination for all persons through age 26 years. (c). Shared clinical decision-making regarding potential HPV vaccination for persons aged 27-45 years, who are at risk of new HPV infection. 2. Male circumcision (LE: 2a): conflicting evidence. In HIV-affected individuals, the course of HPV is more aggressive, with a greater risk of treatment resistance, increased chances of intraepithelial neoplasia as well as cancers. Physician administered. 1. Photodynamic therapy (LE: 1a). 2. Laser (LE: 2b). 3. Surgery (LE: 1a). 4. Electrosurgery (LE: 2c). 5. Cryotherapy (LE: 1b). 6. Immunotherapy (LE: 1b). 7. Podophyllin (LE: 1b). Provider administered. 1. Imiquimod 5%(LE: 1a). 2. Podophyllotoxin (LE: 1b). 3. Sinecatechins (LE: 1a). 4. Cidofovir (LE: 3). 5. 5- Fluorouracil (LE:
Genital warts (also referred to as anogenital warts and condyloma acuminatum) are caused by human papillomavirus types 6 and 11 in 90% of cases. They are transmitted primarily through anogenital contact and penetrative and non-penetrative sex. Transmission can be effectively prevented with vaccination. Current evidence regarding the effects of condom use on the prevalence of genital warts is conflicting. In the United States from 2013-2016, the prevalence of genital warts among individuals ages 18 to 59 years was 1.3% in men and 3.1% in women. The diagnosis is made clinically by the appearance of single or multiple lesions that may coalesce or be the same color as surrounding skin, cauliflower-like, flat, papular, or keratotic. Biopsy is indicated in some cases, such as for atypical lesions. Treatment may be patient- or physician-administered, with choice of treatment informed by shared decision-making. Treatment options may be limited by physician skills and clinic availability. Podofilox 0.5% solution is the most effective patient-administered therapy and carbon dioxide laser therapy, surgery, and electrosurgery are the most effective for wart removal at the end of treatment. All treatment strategies are associated with some recurrence, but most successfully treated warts do not recur. Use of podofilox, imiquimod, and sinecatechins should be avoided in pregnancy.
Cryotherapy is commonly used as ablative treatment of external genital warts (EGW). However, after cryotherapy recurrence of lesions affects on average 45% (42-70%) of subjects in the 6 months after the treatment. Sinecatechins 10% are an effective topical treatment of EGW. A low recurrence rate (<6%) was observed in pivotal phase 3 trials conducted with this product. Topical sinecatechins have demonstrated to significantly reduce the recurrence rate of EGW in subjects treated with laser therapy (The PACT-I trial). So far, no prospective data are available regarding the efficacy of sinecathechins as immunomodulator sequential therapy after cryotherapy in EGW subjects. The purpose of this study was to assess the rate of recurrence lesions after the use of topical sinecatechins 10%, as sequential proactive immunomodulation treatment after cryotherapy in subjects with EGW (The PACT-II Trial: the postablation immunomodulator treatment of condylomata with sinecatechins trial) (Trial Registration number: ISRCTN44037479). In a prospective, assessor-blinded, multicenter trial a total of 55 subjects with a diagnosis of multiple EGW (36 men and 19 women, mean age 47±10 years) and a mean lesion number of 9±7, after their informed consent, were enrolled in the study. All subjects were treated with cryotherapy (an average of 2 sessions). After the ablative treatment, all subjects were instructed to apply sinecatechin 10% ointment 3 times daily for 4 consecutive months. The primary study endpoint was the evaluation (assessor-blinded) of recurrent lesions after 6 months (2 month of follow-up after the conclusion of topical treatment). The secondary study endpoints were the appearance of new EGW lesions (lesions affecting area not treated by cryotherapy) and the local tolerability. At baseline, the mean number of EGW lesions were 9±7. After cryotherapy, the mean lesions number were reduced to 1.6±1.8. At month 4, EGW mean lesion number were 0.2±0.4 (P=0.0001 vs. after cryotherapy).
Doubts remain about the best treatment for managing premalignant lesions (high-grade squamous intraepithelial lesions [HSIL]) associated with anal cancer. The TREATAIN trial was an open-label, randomized study conducted at Hospital Vall d'Hebron (Spain). Persons with human immunodeficiency virus and anal HSIL were randomly assigned 1:1:1 to receive treatment with electrocautery, topical cidofovir 1% ointment, or topical sinecatechins 10%. The primary outcome was histological resolution of HSIL. Secondary outcomes included adverse events, participant satisfaction, human papillomavirus clearance, and HSIL recurrence. Between October 2020 and November 2022, 100 participants were enrolled (36 in the electrocautery arm, 28 in the cidofovir arm, and 36 in the sinecatechins arm). Modified intention-to-treat analysis showed a response rate of 69.4% (95% confidence interval [CI]: 54.4%-84.5%) of patients in the electrocautery group, 82.1% (95% CI: 67.9%-96.3%) in the cidofovir group, and 61.1% (95% CI: 45.2%-77%) in the sinecatechins group (P = .189). During the 48-week follow-up period, recurrence was observed in 7 participants (28%) in the electrocautery group, 7 (30.4%) in the cidofovir group, and 8 (36.4%) in the sinecatechins group (log-rank test, P = .811). Side effects were reported by 97.2% of patients in the electrocautery group, 85.7% in the cidofovir group, and 33% in the sinecatechins group (P < .001). Patients were more satisfied with the sinecatechins treatment (mean, 5.6 ± 0.4), followed by electrocautery (mean, 5.1 ± 0.8), while lower satisfaction was reported with cidofovir treatment (mean, 4.77 ± 0.96) (P < .001). No statistically significant difference was observed in efficacy between treatments; in contrast, sinecatechins was the most accepted and well-tolerated treatment. Clinical Trials Registration. EudraCT: 2018-001730-18; ClinicalTrials.gov: NCT04055142.
Anal intraepithelial neoplasia (AIN) is a dysplasia of the anal transitional epithelium that is associated with human papillomavirus (HPV) infection. High-grade lesions have the potential to develop into anal cancer. The incidence and prevalence of AIN and anal cancer has been increasing over the last decades. Certain groups - including people living with HIV, men who have sex with men (MSM), and those with suppressed immune systems - are at high risk of developing AIN. Targeted excisions using ablative treatments such as electrocauterisation, infrared coagulation, or cryotherapy have been used as first-line therapeutic strategies. Other options include topical treatment with immunomodulators such as imiquimod or cytostatics such as fluorouracil. Ideally, treatment of AIN should have a low risk of complications and result in a low risk of recurrence. This is the first update of a review originally published in 2012. To assess the effects of any therapeutic intervention for anal intraepithelial neoplasia, regardless of gender, age, and comorbidity. We used CENTRAL, MEDLINE, Embase, and five trials registers, together with reference checking, citation searching and contact with study authors to identify the studies that are included in the review. The latest search date was 16 April 2025. We included randomised controlled trials (RCTs) that assessed any type of intervention for AIN. We excluded cluster-randomised and cross-over trials. We excluded people with a histological diagnosis of anal carcinoma, Paget's disease, or Bowenoid papulosis. We used standard methodological procedures expected by Cochrane. Our primary outcomes of interest were: AIN eradication (defined by the absence of histologic criteria OR the presence of a normal epithelium or scarring OR the complete absence of dysplasia); development of anal cancer; and human papillomavirus (HPV) eradication. We assessed the certainty of the evidence using GRADE. Five RCTs met our inclusion criteria, randomising