Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses

This study has been completed.
Sponsor:
Collaborators:
Arizona Disease Control Research Commission
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00608634
First received: February 5, 2008
Last updated: March 27, 2015
Last verified: March 2014
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Precancerous Condition
Interventions: Drug: perillyl alcohol
Other: placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placbeo Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
Low Dose POH 0.30% Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
High Dose POH 0.76% Patients apply POH cream (0.76%) as in arm II.

Participant Flow:   Overall Study
    Placbeo     Low Dose POH 0.30%     High Dose POH 0.76%  
STARTED     28     27     28  
COMPLETED     26     26     27  
NOT COMPLETED     2     1     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
Arm I Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
Arm II Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
Arm III Patients apply POH cream (0.76%) as in arm II.
Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Arm III     Total  
Number of Participants  
[units: participants]
  28     27     28     83  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     14     10     13     37  
>=65 years     14     17     15     46  
Age  
[units: years]
Mean ± Standard Deviation
  66.9  ± 9.9     68.8  ± 10.6     67.6  ± 10.9     67.7  ± 10.4  
Gender  
[units: participants]
       
Female     8     7     5     20  
Male     20     20     23     63  
Region of Enrollment  
[units: participants]
       
United States     28     27     28     83  



  Outcome Measures
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1.  Primary:   Change in Histopathology Score of Sun Damaged Skin by Treatment Group   [ Time Frame: Baseline to 3 months ]

2.  Secondary:   Skin Related Events From Perillyl Alcohol at Administered Doses by Participants   [ Time Frame: 3 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven P. Stratton, PhD
Organization: Arizona Cancer Center
phone: 520-626-9295
e-mail: sstratton@azcc.arizona.edu


No publications provided


Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00608634     History of Changes
Other Study ID Numbers: CDR0000582634, P01CA027502, P30CA023074, UARIZ-HSC-04-27, UARIZ-POH-002
Study First Received: February 5, 2008
Results First Received: April 15, 2011
Last Updated: March 27, 2015
Health Authority: United States: Food and Drug Administration