Trial Outcomes & Findings for Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin (NCT NCT00601640)
NCT ID: NCT00601640
Last Updated: 2017-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
184 participants
Primary outcome timeframe
3 months
Results posted on
2017-03-23
Participant Flow
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.
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.
Participant milestones
| Measure |
Eflornithine Hydrochloride
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Diclofenac Sodium
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Eflornithine Hydrochloride/Diclofenac Sodium
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 Study
STARTED
|
52
|
52
|
52
|
|
Overall Study
COMPLETED
|
47
|
47
|
42
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
10
|
Reasons for withdrawal
| Measure |
Eflornithine Hydrochloride
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Diclofenac Sodium
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Eflornithine Hydrochloride/Diclofenac Sodium
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 Study
Withdrawal by Subject
|
3
|
0
|
7
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
4
|
2
|
|
Overall Study
intercurrent illness
|
1
|
0
|
0
|
|
Overall Study
change in eligibility status
|
0
|
1
|
1
|
Baseline Characteristics
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
Baseline characteristics by cohort
| Measure |
Arm I
n=52 Participants
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Arm II
n=52 Participants
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Arm III
n=52 Participants
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
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
52 participants
n=5 Participants
|
156 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPutrescine 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.
Outcome measures
| Measure |
Eflornithine Hydrochloride
n=47 Participants
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Diclofenac Sodium
n=47 Participants
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Eflornithine Hydrochloride/Diclofenac Sodium
n=42 Participants
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.
|
|---|---|---|---|
|
Changes in Putrescine Over 3 Months
|
0.03 nmol/g skin
Standard Error 1.12
|
1.45 nmol/g skin
Standard Error 1.23
|
0.2 nmol/g skin
Standard Error 0.96
|
PRIMARY outcome
Timeframe: 3 monthsAdverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up.
Outcome measures
| Measure |
Eflornithine Hydrochloride
n=52 Participants
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Diclofenac Sodium
n=52 Participants
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Eflornithine Hydrochloride/Diclofenac Sodium
n=52 Participants
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.
|
|---|---|---|---|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Burning and Stinging None
|
48 participants
|
44 participants
|
48 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Burning and stinging Mild
|
4 participants
|
8 participants
|
3 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
burning and stinging Moderate
|
0 participants
|
0 participants
|
1 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Burning and Stinging Severe
|
0 participants
|
0 participants
|
0 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Pruritis None
|
42 participants
|
33 participants
|
40 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Pruritis Mild
|
9 participants
|
12 participants
|
6 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Pruritis Moderate
|
1 participants
|
6 participants
|
6 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Pruritis Severe
|
0 participants
|
1 participants
|
0 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Rash, Redness. Erythema-None
|
46 participants
|
34 participants
|
40 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Rash, Redness. Erythema-Mild
|
5 participants
|
10 participants
|
7 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Rash, Redness. Erythema-Moderate
|
1 participants
|
8 participants
|
5 participants
|
|
Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months
Rash, Redness. Erythema-Severe
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 monthsChange 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.
Outcome measures
| Measure |
Eflornithine Hydrochloride
n=48 Participants
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Diclofenac Sodium
n=46 Participants
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Eflornithine Hydrochloride/Diclofenac Sodium
n=42 Participants
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.
|
|---|---|---|---|
|
Change in Histologic Score Diagnosis and Treatment Group
|
0.33 units on a scale
Standard Error 0.15
|
0.26 units on a scale
Standard Error 0.13
|
0.64 units on a scale
Standard Error 0.18
|
Adverse Events
Arm I
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm II
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Arm III
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I
n=52 participants at risk
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
|
Arm II
n=52 participants at risk
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
|
Arm III
n=52 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Burning/Stinging
|
7.7%
4/52 • Three months
|
15.4%
8/52 • Three months
|
7.7%
4/52 • Three months
|
|
Skin and subcutaneous tissue disorders
Rash, Redness, Erythema
|
11.5%
6/52 • Three months
|
34.6%
18/52 • Three months
|
23.1%
12/52 • Three months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
19.2%
10/52 • Three months
|
38.5%
20/52 • Three months
|
23.1%
12/52 • Three months
|
Additional Information
Joanne Jeter, MD
University of Arizona/Arizona Cancer Center
Phone: 520.626.9295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place