Recurrent and nonrecurrent condyloma treatment
- Conditions
- Recurrent and non-recurrent genital condylomaUrological and Genital DiseasesOther predominantly sexually transmitted diseases, not elsewhere classified
- Registration Number
- ISRCTN86355789
- Lead Sponsor
- aboratorio Elea SACIFyA (Argentina)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 132
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 21 and 65 years inclusive
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 38ºC) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assess the safety of the perilesional application of CIGB-300 for the treatment of recurrent and non-recurrent condylomatous lesions <br>2. To assess CIGB-300 effect in the resolution of recurrent and non-recurrent, when considering the reduction in the number of lesions, lesion total area and the occurrence of recurrence of episodes
- Secondary Outcome Measures
Name Time Method 1. To assess the effect of CIGB-300 perilesional application in the reduction in number and area of genital warts lesions treated directly <br>2. To determine the locoregional effect of the product under study by assessing the area and number of genital warts not directly treated<br>3. To evaluate the possible effect of the product to avoid recurrence of the lesions resolved during treatment, assessed post-treatment<br>4. Define the optimal dose, in comparison with placebo <br>5. Identify, assess and report adverse events that occur during treatment in each treatment group so to identify the safest and most effective dose