Randomised, Blind and Placebo-controlled Trial for the CIGB-300 Perilesional Application in Two Dose Levels in the Recurrent and Non Recurrent Genital Condyloma
Inclusion Criteria:
1. Informed consent signed by the patient
2. Women with clinical diagnosis of recurrent and non recurrent genital condyloma
3. Presence of a condylomatous lesion or area of external confluent condylomatous
lesions of not less than 20 or more than 80 mm2
4. The number of warts should be between 2 and 20
5. External genital warts or in perigenital regions
6. Negative pregnancy test
7. Age between 18 and 65 years inclusive
Exclusion Criteria:
1. Having received surgery treatment, ablative or immunomodulator treatment during the
30 days prior to inclusion
2. Presence of genital warts only located in the cervix, vagina, bladder or rectum
3. Pregnancy and lactation
4. Patients of childbearing age who are not using an adequate contraception method
during treatment to prevent pregnancy.
5. Inadequately controlled chronic diseases (hypertension, diabetes, chronic kidney
failure, heart failure, hyperthyroidism, malignant neoplasms, epilepsy, severe mental
depression)
6. Patients with previous diagnosis of bleeding disorders and other chronic blood
disorders (von Willebrand disease, haemophilia, leukaemia) or use of anticoagulants
within 30 days before the study
7. Current genital herpes, which requires application of topical antivirals
8. Immunosuppressive disease, current intake of immunosuppressive/ immunomodulatory
drugs within 30 days before the study.
9. Autoimmune Diseases (Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis,
Diabetes)
10. Severe allergy history as urticaria, dermatitis or persistent bronchitis and
bronchial asthma
11. Febrile illness (temperature greater than 38ÂșC) at the time or within 24 hours prior
to administration of the product or suspected acute infectious disease by clinical
examination
12. Diseases that compromise the patient's consciousness or the ability to give informed
consent or to collaborate in the study
13. Concomitant skin lesions that prevent the administration of condylomatous lesions at
the proposed site
14. Participating in another clinical trial