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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CIGB-300 - 5 mg | Experimental |
| |
| CIGB-300 - 15 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROAPOPTOTIC PEPTIDE CIGB 300 | Drug | CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with complete response of target lesion in each study group | Up to one year | |
| Number of patients with adverse events during the application of the study drug | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Elea SACIFyA | Capital Federal | Buenos Aires | C1417AZE | Argentina |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| Up to one year |
| Effect of CIGB300 to avoid recurrence of the lesions | Up to one year |
| Optimal dose, in comparison with placebo | Up to one year |
| Number of patients with adverse events | Up to one year |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |