Recurrent and Nonrecurrent Condyloma Treatment

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier:
NCT01639638
First received: May 14, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Condyloma
Nonrecurrent Condyloma
Drug: PROAPOPTOTIC PEPTIDE CIGB 300
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: 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

Further study details as provided by Laboratorio Elea S.A.C.I.F. y A.:

Primary Outcome Measures:
  • Number of patients with complete response of target lesion in each study group [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Number of patients with adverse events during the application of the study drug [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]
  • Effect of CIGB300 to avoid recurrence of the lesions [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Optimal dose, in comparison with placebo [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]
  • Number of patients with adverse events [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
Experimental: CIGB-300 - 5 mg Drug: PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
Experimental: CIGB-300 - 15 mg Drug: PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639638

Locations
Argentina
Laboratorio Elea SACIFyA
Capital Federal, Buenos Aires, Argentina, C1417AZE
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.
  More Information

Additional Information:
No publications provided

Responsible Party: Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier: NCT01639638     History of Changes
Other Study ID Numbers: CONDI 02 AR
Study First Received: May 14, 2012
Last Updated: July 29, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Laboratorio Elea S.A.C.I.F. y A.:
Recurrent and non-recurrent genital condyloma

Additional relevant MeSH terms:
Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014