Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

This study has been completed.
Sponsor:
Information provided by:
Tigris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00285207
First received: January 30, 2006
Last updated: September 23, 2010
Last verified: September 2010
Results First Received: August 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Interventions: Drug: placebo
Drug: A007

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo (no treatment)
A007 Experimental A007

Participant Flow:   Overall Study
    Placebo     A007  
STARTED     70     77  
Treated     63     75  
COMPLETED     61     71  
NOT COMPLETED     9     6  
Lost to Follow-up                 3                 2  
Withdrawal by Subject                 5                 2  
Pregnancy                 1                 1  
non-compliance                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Placebo (no treatment)
A007 Experimental A007
Total Total of all reporting groups

Baseline Measures
    Placebo     A007     Total  
Number of Participants  
[units: participants]
  70     77     147  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     70     77     147  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28  ± 6     28.7  ± 7.9     28.4  ± 7.1  
Gender  
[units: participants]
     
Female     70     77     147  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     70     77     147  



  Outcome Measures

1.  Primary:   Pathological Response   [ Time Frame: baseline and 4 months ]

2.  Secondary:   Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.   [ Time Frame: over the course of the trial ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection.   [ Time Frame: over the course of the trial ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.   [ Time Frame: over the course of the trial ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: TigrisPharmaceuticals
e-mail: info@tigrispharma.com


Publications:
Morgan, LR, Hooper, CL, Rodgers, AH Culotta, V et al. 4,4'-Dihydroxy benzophenone -2,4-dinitrophenylhydrazone (A-007) A Modulator of CD45+ T Lymphocytes in HPV Infected Anogenital Epithelium. In: HPV Vaccines and Immune Therapy, Cambridge, United Kingdom, 2003


Responsible Party: Chief Medical Officer, Tigris
ClinicalTrials.gov Identifier: NCT00285207     History of Changes
Other Study ID Numbers: TG-001
Study First Received: January 30, 2006
Results First Received: August 30, 2010
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration