NCT01639638

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. 1.Placebo
  2. 2.CIGB-300 - 5 mg
  3. 3.CIGB-300 - 15 mg

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

May 14, 2012

Last Update Submit

March 11, 2015

Conditions

Recurrent CondylomaNonrecurrent Condyloma

Keywords

Recurrent and non-recurrent genital condyloma

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • 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

    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

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: PROAPOPTOTIC PEPTIDE CIGB 300

CIGB-300 - 5 mg

EXPERIMENTAL
Drug: PROAPOPTOTIC PEPTIDE CIGB 300

CIGB-300 - 15 mg

EXPERIMENTAL
Drug: PROAPOPTOTIC PEPTIDE CIGB 300

Interventions

PROAPOPTOTIC PEPTIDE CIGB 300DRUG

CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.

CIGB-300 - 15 mgCIGB-300 - 5 mgPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio Elea SACIFyA

Capital Federal, Buenos Aires, C1417AZE, Argentina

Location

Related Links

MeSH Terms

Conditions

Condylomata AcuminataRecurrence

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

July 13, 2012

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

AR(1)