Trial Outcomes & Findings for Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses (NCT NCT00608634)
NCT ID: NCT00608634
Last Updated: 2015-04-01
Results Overview
The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 \& 2), 2- inflammation (grades 0, 1 \& 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were \>3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of \>3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2015-04-01
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
28
|
|
Overall Study
COMPLETED
|
26
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
Baseline characteristics by cohort
| Measure |
Arm I
n=28 Participants
Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
|
Arm II
n=27 Participants
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
n=28 Participants
Patients apply POH cream (0.76%) as in arm II.
|
Total
n=83 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
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
28 participants
n=5 Participants
|
83 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: change in histopathological scoring was calculated only for participants with baseline and end of study measurements. (n=79)
The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 \& 2), 2- inflammation (grades 0, 1 \& 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were \>3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of \>3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.
Outcome measures
| Measure |
Placebo
n=26 Participants
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%
n=26 Participants
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%
n=27 Participants
Patients apply POH cream (0.76%) as in arm II.
|
|---|---|---|---|
|
Change in Histopathology Score of Sun Damaged Skin by Treatment Group
|
0.4 units on a scale
Standard Deviation 1.3
|
-0.1 units on a scale
Standard Deviation 1.3
|
0.1 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 3 monthsThe events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI)
Outcome measures
| Measure |
Placebo
n=28 Participants
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%
n=27 Participants
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%
n=28 Participants
Patients apply POH cream (0.76%) as in arm II.
|
|---|---|---|---|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
No rash, redness, erythema
|
16 participants
|
12 participants
|
13 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
No flaking, crusting
|
23 participants
|
20 participants
|
23 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
No burning or stinging
|
25 participants
|
24 participants
|
27 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
No pruritus
|
22 participants
|
23 participants
|
23 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Mild rash, redness, erythema
|
11 participants
|
14 participants
|
15 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Mild flaking, crusting
|
5 participants
|
7 participants
|
4 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Mild burning or stinging
|
2 participants
|
3 participants
|
1 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Mild pruritus
|
6 participants
|
3 participants
|
4 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Moderate rash, redness, erythema
|
1 participants
|
1 participants
|
0 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Moderate flaking, crusting
|
0 participants
|
0 participants
|
1 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Moderate burning or stinging
|
1 participants
|
0 participants
|
0 participants
|
|
Skin Related Events From Perillyl Alcohol at Administered Doses by Participants
Moderate pruritus
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Low Dose POH 0.3%
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
High Dose POH 0.76%
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
|
Low Dose POH 0.3%
n=27 participants at risk
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%
n=28 participants at risk
Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
SCC in treatment area
|
7.1%
2/28 • Number of events 2 • 3 months for each participant.
Standard Questionnaire
|
7.4%
2/27 • Number of events 2 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
|
Skin and subcutaneous tissue disorders
SCC outside of treatment area
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
3.7%
1/27 • Number of events 1 • 3 months for each participant.
Standard Questionnaire
|
3.6%
1/28 • Number of events 1 • 3 months for each participant.
Standard Questionnaire
|
|
Cardiac disorders
Stent Replacement
|
3.6%
1/28 • Number of events 1 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/27 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
|
Skin and subcutaneous tissue disorders
BCC outside of treatment area
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
3.7%
1/27 • Number of events 1 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
3.7%
1/27 • Number of events 1 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
|
Skin and subcutaneous tissue disorders
Melanoma
|
3.6%
1/28 • Number of events 1 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/27 • 3 months for each participant.
Standard Questionnaire
|
0.00%
0/28 • 3 months for each participant.
Standard Questionnaire
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
|
Low Dose POH 0.3%
n=27 participants at risk
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%
n=28 participants at risk
Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild Rash, Redness, Erythema
|
39.3%
11/28 • Number of events 11 • 3 months for each participant.
Standard Questionnaire
|
51.9%
14/27 • Number of events 14 • 3 months for each participant.
Standard Questionnaire
|
53.6%
15/28 • Number of events 15 • 3 months for each participant.
Standard Questionnaire
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place