Recurrent CondylomaPhase 2/3NCT01639638
Recurrent and Nonrecurrent Condyloma Treatment
A Phase 2/3 study testing PROAPOPTOTIC PEPTIDE CIGB 300 in people with Recurrent Condyloma and Nonrecurrent Condyloma, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Recurrent Condyloma, Nonrecurrent Condyloma
- What is being tested?
- PROAPOPTOTIC PEPTIDE CIGB 300
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2010to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having received surgery treatment, ablative or immunomodulator treatment during the 30 days prior to inclusion
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Laboratorio Elea SACIFyA
Capital Federal, Buenos Aires, C1417AZE
About this study
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
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
- Placebo
- CIGB-300 - 5 mg
- CIGB-300 - 15 mg
Read more
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
- Being tested
- PROAPOPTOTIC PEPTIDE CIGB 300
- Keywords
- Recurrent and non-recurrent genital condyloma
- Medical subject headings
- Condylomata Acuminata, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROAPOPTOTIC PEPTIDE CIGB 300Drug
CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: PROAPOPTOTIC PEPTIDE CIGB 300 |
| CIGB-300 - 5 mg | Experimental | Not described Receives: Drug: PROAPOPTOTIC PEPTIDE CIGB 300 |
| CIGB-300 - 15 mg | Experimental | Not described Receives: Drug: PROAPOPTOTIC PEPTIDE CIGB 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete response of target lesion in each study group
Measured: Up to one year
Number of patients with adverse events during the application of the study drug
Measured: 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
Measured: Up to one year
Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated
Measured: Up to one year
Effect of CIGB300 to avoid recurrence of the lesions
Measured: Up to one year
Optimal dose, in comparison with placebo
Measured: Up to one year
Number of patients with adverse events
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent CondylomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639638
- Sponsor's protocol ID
- CONDI 02 AR
- Status last verified
- Mar 2015
- First submitted
- 14 May 2012
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01639638
- Acronym / sponsor ID
- CONDI 02 AR
- Conditions
- Recurrent Condyloma, Nonrecurrent Condyloma
- Keywords
- Recurrent and non-recurrent genital condyloma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Placebo
- CIGB-300 - 5 mg
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- Having received surgery treatment, ablative or immunomodulator treatment during the 30 days prior to inclusion
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROAPOPTOTIC PEPTIDE CIGB 300CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS. | Drug | CIGB-300 - 15 mg, CIGB-300 - 5 mg, Placebo |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
- Related InfoLink provided by the sponsor.
Related trials for Recurrent Condyloma
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PROAPOPTOTIC PEPTIDE CIGB 300 in people with Recurrent Condyloma and Nonrecurrent Condyloma, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complete response of target lesion in each study group (time frame: Up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2015.