NCT01639638

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Recurrent Condyloma
• Nonrecurrent Condyloma

Interventions

Type	Name	Description
DRUG	PROAPOPTOTIC PEPTIDE CIGB 300	CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-12-01
• Completion: 2014-12-01
• First posted: 2012-07-13
• Last updated: 2015-03-12

Locations

1 site across 1 country: Argentina