Recurrent and Nonrecurrent Condyloma Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01639638
Recruitment Status : Terminated
First Posted : July 13, 2012
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.

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. 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.

Condition or disease Intervention/treatment Phase
Recurrent Condyloma Nonrecurrent Condyloma Drug: PROAPOPTOTIC PEPTIDE CIGB 300 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

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.

Primary Outcome Measures :
  1. Number of patients with complete response of target lesion in each study group [ Time Frame: Up to one year ]
  2. Number of patients with adverse events during the application of the study drug [ Time Frame: Up to one year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Locoregional effect of CIGB300 by assessing the area and number of genital warts lesions not directly treated [ Time Frame: Up to one year ]
  3. Effect of CIGB300 to avoid recurrence of the lesions [ Time Frame: Up to one year ]
  4. Optimal dose, in comparison with placebo [ Time Frame: Up to one year ]
  5. Number of patients with adverse events [ Time Frame: Up to one year ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01639638

Laboratorio Elea SACIFyA
Capital Federal, Buenos Aires, Argentina, C1417AZE
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.

Additional Information:
Responsible Party: Laboratorio Elea S.A.C.I.F. y A. Identifier: NCT01639638     History of Changes
Other Study ID Numbers: CONDI 02 AR
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

Keywords provided by Laboratorio Elea S.A.C.I.F. y A.:
Recurrent and non-recurrent genital condyloma

Additional relevant MeSH terms:
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases