A Phase 2/3 interventional study of PROAPOPTOTIC PEPTIDE CIGB 300 in Recurrent Condyloma and Nonrecurrent Condyloma, sponsored by Laboratorio Elea Phoenix S.A.. Terminated at 1 site in Argentina. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-12.
Sponsored by Laboratorio Elea Phoenix S.A. · Phase 2/3, Interventional, and Treatment
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
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.
94 studies on the registry are indexed under Condylomata Acuminata; 7 are open to participants now.
This study's enrollment of 132 is close to the median of 140 across 77 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Laboratorio Elea Phoenix S.A. is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PROAPOPTOTIC PEPTIDE CIGB 300
Drug: PROAPOPTOTIC PEPTIDE CIGB 300
Drug: PROAPOPTOTIC PEPTIDE CIGB 300
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
Number of patients with complete response of target lesion in each study group
Time frame: Up to one year
Number of patients with adverse events during the application of the study drug
Time frame: Up to one year
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
Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated
Time frame: Up to one year
Effect of CIGB300 to avoid recurrence of the lesions
Time frame: Up to one year
Optimal dose, in comparison with placebo
Time frame: Up to one year
Number of patients with adverse events
Time frame: Up to one year
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Laboratorio Elea Phoenix S.A.