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Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin

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ClinicalTrials.gov Identifier: NCT00601640
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Other Benign Neoplasm of Skin, Unspecified
Interventions Drug: Diclofenac Na gel
Drug: Eflornithine HCL ointment
Enrollment 184
Recruitment Details 184 participants were accrued. 18 were accrued when an interim analyses resulted in a change in formulation and dosing. The primary analyses is based on 166 accrued after this change.
Pre-assignment Details 166 participants were accrued after the change in formulation. 10 participants were not randomized for various reasons. 156 participants were randomized to one of the 3 treatment groups.
Arm/Group Title Eflornithine Hydrochloride Diclofenac Sodium Eflornithine Hydrochloride/Diclofenac Sodium
Hide Arm/Group Description Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90. Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90. Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
Period Title: Overall Study
Started 52 52 52
Completed 47 47 42
Not Completed 5 5 10
Reason Not Completed
Withdrawal by Subject             3             0             7
Death             1             0             0
Adverse Event             0             4             2
intercurrent illness             1             0             0
change in eligibility status             0             1             1
Arm/Group Title Arm I Arm II Arm III Total
Hide Arm/Group Description Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90. Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90. Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90. Total of all reporting groups
Overall Number of Baseline Participants 52 52 52 156
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 52 participants 156 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  71.2%
35
  67.3%
30
  57.7%
102
  65.4%
>=65 years
15
  28.8%
17
  32.7%
22
  42.3%
54
  34.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 52 participants 156 participants
59.3  (9.5) 60.4  (11.0) 61.4  (10.4) 60.4  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 52 participants 156 participants
Female
37
  71.2%
37
  71.2%
38
  73.1%
112
  71.8%
Male
15
  28.8%
15
  28.8%
14
  26.9%
44
  28.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 52 participants 52 participants 156 participants
52 52 52 156
1.Primary Outcome
Title Changes in Putrescine Over 3 Months
Hide Description Putrescine is measured in nmole/g skin per biopsy. Baseline and End of Study biopsies were measured and the change was produced by subtracting baseline levels from End of Study levels. There was one baseline biopsy and one End of Study biopsy per participant.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eflornithine Hydrochloride Diclofenac Sodium Eflornithine Hydrochloride/Diclofenac Sodium
Hide Arm/Group Description:
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
Overall Number of Participants Analyzed 47 47 42
Mean (Standard Error)
Unit of Measure: nmol/g skin
0.03  (1.12) 1.45  (1.23) 0.2  (0.96)
2.Primary Outcome
Title Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Hide Description Adverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eflornithine Hydrochloride Diclofenac Sodium Eflornithine Hydrochloride/Diclofenac Sodium
Hide Arm/Group Description:
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90
Overall Number of Participants Analyzed 52 52 52
Measure Type: Number
Unit of Measure: participants
Burning and Stinging None 48 44 48
Burning and stinging Mild 4 8 3
burning and stinging Moderate 0 0 1
Burning and Stinging Severe 0 0 0
Pruritis None 42 33 40
Pruritis Mild 9 12 6
Pruritis Moderate 1 6 6
Pruritis Severe 0 1 0
Rash, Redness. Erythema-None 46 34 40
Rash, Redness. Erythema-Mild 5 10 7
Rash, Redness. Erythema-Moderate 1 8 5
Rash, Redness. Erythema-Severe 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eflornithine Hydrochloride, Diclofenac Sodium, Eflornithine Hydrochloride/Diclofenac Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Change in Histologic Score Diagnosis and Treatment Group
Hide Description Change scores were computed by subtracting baseline histologic score from End of Study histologic score. Slides were formalin fixed. Histologic Score has been developed by this research group over the course of Grant (reference below). A standardized form captures data on the following criteria: basal or suprabasilar pleomorphism (atypia); inflammation; hyperkeratosis; parakeratosis. The atypia and inflammation were rated as: none (0), mild to moderate(1), and severe (2). The remaining criteria were rated as present (1) or absent (0). Histologic Scores were computed by adding together the codes for the histologic criteria. Higher scores reflected higher level of epidermal /dermal damage.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eflornithine Hydrochloride Diclofenac Sodium Eflornithine Hydrochloride/Diclofenac Sodium
Hide Arm/Group Description:
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
Overall Number of Participants Analyzed 48 46 42
Mean (Standard Error)
Unit of Measure: units on a scale
0.33  (0.15) 0.26  (0.13) 0.64  (0.18)
Time Frame Three months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90. Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90. Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
All-Cause Mortality
Arm I Arm II Arm III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II Arm III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/52 (0.00%)   0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I Arm II Arm III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/52 (38.46%)   45/52 (86.54%)   28/52 (53.85%) 
Skin and subcutaneous tissue disorders       
Burning/Stinging  1  4/52 (7.69%)  8/52 (15.38%)  4/52 (7.69%) 
Rash, Redness, Erythema  1  6/52 (11.54%)  18/52 (34.62%)  12/52 (23.08%) 
Pruritis  1  10/52 (19.23%)  20/52 (38.46%)  12/52 (23.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joanne Jeter, MD
Organization: University of Arizona/Arizona Cancer Center
Phone: 520.626.9295
EMail: jjeter@azcc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00601640     History of Changes
Other Study ID Numbers: 07-0032-04
P30CA023074 ( U.S. NIH Grant/Contract )
P01CA027502 ( U.S. NIH Grant/Contract )
UARIZ-BIO-06182 ( Other Identifier: UA IRB no. )
07-0032-04 ( Other Identifier: UA IRB )
First Submitted: January 22, 2008
First Posted: January 28, 2008
Results First Submitted: April 15, 2011
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017