Clinical trial NCT01639638: Recurrent and Nonrecurrent Condyloma Treatment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Recurrent Condyloma
Nonrecurrent Condyloma
Keywords: Recurrent and non-recurrent genital condyloma
Lead sponsor: Laboratorio Elea Phoenix S.A.
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with complete response of target lesion in each study group
timeFrame: Up to one year
measure: Number of patients with adverse events during the application of the study drug
timeFrame: Up to one year
Secondary outcomes:
measure: Effect of the perilesional application of CIGB300 in the reduction in the number and area of genital warts lesions treated directly
timeFrame: Up to one year
measure: Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated
timeFrame: Up to one year
measure: Effect of CIGB300 to avoid recurrence of the lesions
timeFrame: Up to one year
measure: Optimal dose, in comparison with placebo
timeFrame: Up to one year
measure: Number of patients with adverse events
timeFrame: Up to one year
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Laboratorio Elea SACIFyA
state: Buenos Aires
Study officials:
References: