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Recurrent and Nonrecurrent Condyloma Treatment

Primary Purpose

Recurrent Condyloma, Nonrecurrent Condyloma

Status
Terminated
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
PROAPOPTOTIC PEPTIDE CIGB 300
Sponsored by
Laboratorio Elea Phoenix S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Condyloma focused on measuring Recurrent and non-recurrent genital condyloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratorio Elea SACIFyA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

CIGB-300 - 5 mg

CIGB-300 - 15 mg

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with complete response of target lesion in each study group
Number of patients with adverse events during the application of the study drug

Secondary Outcome Measures

Effect of the perilesional application of CIGB300 in the reduction in the number and area of genital warts lesions treated directly
Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated
Effect of CIGB300 to avoid recurrence of the lesions
Optimal dose, in comparison with placebo
Number of patients with adverse events

Full Information

First Posted
May 14, 2012
Last Updated
March 11, 2015
Sponsor
Laboratorio Elea Phoenix S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01639638
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorio Elea Phoenix S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Placebo CIGB-300 - 5 mg 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Condyloma, Nonrecurrent Condyloma
Keywords
Recurrent and non-recurrent genital condyloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CIGB-300 - 5 mg
Arm Type
Experimental
Arm Title
CIGB-300 - 15 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PROAPOPTOTIC PEPTIDE CIGB 300
Intervention Description
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
Primary Outcome Measure Information:
Title
Number of patients with complete response of target lesion in each study group
Time Frame
Up to one year
Title
Number of patients with adverse events during the application of the study drug
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Effect of the perilesional application of CIGB300 in the reduction in the number and area of genital warts lesions treated directly
Time Frame
Up to one year
Title
Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated
Time Frame
Up to one year
Title
Effect of CIGB300 to avoid recurrence of the lesions
Time Frame
Up to one year
Title
Optimal dose, in comparison with placebo
Time Frame
Up to one year
Title
Number of patients with adverse events
Time Frame
Up to one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent signed by the patient Women with clinical diagnosis of recurrent and non recurrent genital condyloma Presence of a condylomatous lesion or area of external confluent condylomatous lesions of not less than 20 or more than 80 mm2 The number of warts should be between 2 and 20 External genital warts or in perigenital regions Negative pregnancy test Age between 18 and 65 years inclusive Exclusion Criteria: Having received surgery treatment, ablative or immunomodulator treatment during the 30 days prior to inclusion Presence of genital warts only located in the cervix, vagina, bladder or rectum Pregnancy and lactation Patients of childbearing age who are not using an adequate contraception method during treatment to prevent pregnancy. Inadequately controlled chronic diseases (hypertension, diabetes, chronic kidney failure, heart failure, hyperthyroidism, malignant neoplasms, epilepsy, severe mental depression) 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 Current genital herpes, which requires application of topical antivirals Immunosuppressive disease, current intake of immunosuppressive/ immunomodulatory drugs within 30 days before the study. Autoimmune Diseases (Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Diabetes) Severe allergy history as urticaria, dermatitis or persistent bronchitis and bronchial asthma 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 Diseases that compromise the patient's consciousness or the ability to give informed consent or to collaborate in the study Concomitant skin lesions that prevent the administration of condylomatous lesions at the proposed site Participating in another clinical trial
Facility Information:
Facility Name
Laboratorio Elea SACIFyA
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1417AZE
Country
Argentina

12. IPD Sharing Statement

Links:
URL
http://www.elea.com
Description
Related Info

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Recurrent and Nonrecurrent Condyloma Treatment

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