Nonrecurrent Condyloma Clinical Trial
Official title:
Randomised, Blind and Placebo-controlled Trial for the CIGB-300 Perilesional Application in Two Dose Levels in the Recurrent and Non Recurrent Genital Condyloma
Treatment is considered successful if the difference in the response in the reduction of the
affected area is above 30% for any of the doses compared to placebo Patients will be
randomised to 1 of 3 treatment arms
1. Placebo
2. CIGB-300 - 5 mg
3. CIGB-300 - 15 mg
A two week screening visit will take place to assess patient eligibility, at least 2 to 5
target lesions (area of the lesion between 20 to 80 mm2), should be identified. Patients
included in the study will be randomly assigned to one of three study arms. Treatment
consists of 3 perilesional applications at the base of the target lesion every 48 hours with
a window of ±24hs.
After each application the potential local and systemic adverse events will be identified
and monitored.
After the last application is made, weekly clinical evaluations for 3 weeks and then every
two weeks, until week 12 will take place. At this time, clinical assessment of efficacy will
be carried out that will define the response to treatment.
After this visit, patients will be followed every 3 months until one year after the last
treatment has been completed to confirm response and long-term security of the CIGB-300
application.
At screening, at 2 and 8 weeks as well as at 6 and 12 months post-treatment blood studies
will be conducted to assess the safety from the systemic point of view.
| Status | Terminated |
| Enrollment | 132 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Laboratorio Elea SACIFyA | Capital Federal | Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratorio Elea S.A.C.I.F. y A. |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with complete response of target lesion in each study group | Up to one year | No | |
| Primary | Number of patients with adverse events during the application of the study drug | Up to one year | Yes | |
| Secondary | Effect of the perilesional application of CIGB300 in the reduction in the number and area of genital warts lesions treated directly | Up to one year | Yes | |
| Secondary | Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated | Up to one year | Yes | |
| Secondary | Effect of CIGB300 to avoid recurrence of the lesions | Up to one year | No | |
| Secondary | Optimal dose, in comparison with placebo | Up to one year | Yes | |
| Secondary | Number of patients with adverse events | Up to one year | Yes |