Recurrent and Nonrecurrent Condyloma Treatment

Randomised, Blind and Placebo-controlled Trial for the CIGB-300 Perilesional Application in Two Dose Levels in the Recurrent and Non Recurrent Genital Condyloma

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.

Study Overview

• Status: Terminated
• Conditions: Recurrent Condyloma; Nonrecurrent Condyloma
• Intervention / Treatment: Drug: PROAPOPTOTIC PEPTIDE CIGB 300

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, C1417AZE
      • Laboratorio Elea SACIFyA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Laboratorio Elea Phoenix S.A.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Recurrent and non-recurrent genital condyloma
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Skin Diseases, Infectious; Warts; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Recurrence; Condylomata Acuminata
• Other Study ID Numbers: CONDI 02 AR