Trial Outcomes & Findings for A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp) (NCT NCT00700063)
NCT ID: NCT00700063
Last Updated: 2015-04-14
Results Overview
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
Baseline
Results posted on
2015-04-14
Participant Flow
First patient randomized: 24 June 2008 Last patient completed Day 57: 20 October 2008
Participant milestones
| Measure |
1. PEP005 Topical Gel 0.005%
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
Two days treatment day 1, 2
|
4. Vehicle Gel
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
33
|
33
|
33
|
34
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
34
|
33
|
31
|
31
|
34
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Baseline characteristics by cohort
| Measure |
1. PEP005 Topical Gel 0.005%
n=33 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
Total
n=265 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
112 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
22 Participants
n=6 Participants
|
153 Participants
n=6 Participants
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 11.0 • n=21 Participants
|
67.7 years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
67.2 years
STANDARD_DEVIATION 10.1 • n=115 Participants
|
69.3 years
STANDARD_DEVIATION 10.7 • n=6 Participants
|
67.4 years
STANDARD_DEVIATION 9.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
28 Participants
n=6 Participants
|
237 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
31 participants
n=5 Participants
|
29 participants
n=4 Participants
|
29 participants
n=21 Participants
|
31 participants
n=10 Participants
|
25 participants
n=115 Participants
|
28 participants
n=6 Participants
|
232 participants
n=6 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=10 Participants
|
7 participants
n=115 Participants
|
5 participants
n=6 Participants
|
33 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
Incidence of AEs recorded throughout the study
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of AEs Recorded Throughout the Study
|
12 participants
|
12 participants
|
8 participants
|
11 participants
|
11 participants
|
14 participants
|
22 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
Incidence of SAE recorded throughout the study
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of SAE Recorded Throughout the Study
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized.
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence Rate and Severity of LSRs Following Study Medication Application
|
1.4 scores on a scale
Standard Deviation 1.3
|
1.6 scores on a scale
Standard Deviation 1.3
|
1.3 scores on a scale
Standard Deviation 0.9
|
1.4 scores on a scale
Standard Deviation 1.1
|
1.6 scores on a scale
Standard Deviation 1.5
|
1.5 scores on a scale
Standard Deviation 1.3
|
1.3 scores on a scale
Standard Deviation 1.0
|
1.7 scores on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Day 57Population: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized.
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence Rate and Severity of LSRs Following Study Medication Application
|
0.8 units on a scale
Standard Deviation 1.1
|
1.1 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 1.2
|
1.4 units on a scale
Standard Deviation 1.4
|
1.1 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 1.3
|
1.1 units on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: BaselinePopulation: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Hyperpigmentation Following Study Medication Application
|
15 participants
|
15 participants
|
11 participants
|
8 participants
|
13 participants
|
12 participants
|
15 participants
|
15 participants
|
PRIMARY outcome
Timeframe: Day 57Population: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Hyperpigmentation Following Study Medication Application
|
13 participants
|
13 participants
|
7 participants
|
6 participants
|
8 participants
|
11 participants
|
11 participants
|
15 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Hypopigmentation Following Study Medication Application
|
7 participants
|
10 participants
|
6 participants
|
8 participants
|
10 participants
|
9 participants
|
16 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Day 57Population: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Hypopigmentation Following Study Medication Application
|
4 participants
|
6 participants
|
6 participants
|
6 participants
|
9 participants
|
9 participants
|
12 participants
|
6 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Scarring Following Study Medication Application
|
1 participants
|
3 participants
|
2 participants
|
3 participants
|
6 participants
|
1 participants
|
10 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Day 57Population: One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Scarring Following Study Medication Application
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
5 participants
|
1 participants
|
5 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Day 57Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=33 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Complete Clearance Rate of AK Lesions;
|
5 participants
|
10 participants
|
12 participants
|
0 participants
|
11 participants
|
6 participants
|
16 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 57 daysPartial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp
Outcome measures
| Measure |
1. PEP005 Topical Gel 0.005%
n=33 Participants
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 Participants
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 Participants
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 Participants
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 Participants
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 Participants
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 Participants
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 Participants
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
|
11 participants
|
17 participants
|
17 participants
|
3 participants
|
14 participants
|
9 participants
|
23 participants
|
4 participants
|
Adverse Events
1. PEP005 Topical Gel 0.005%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
2. PEP005 Topical Gel 0.01%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3. PEP005 Topical Gel 0.015%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
4. Vehicle Gel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
5. PEP005 Topical Gel 0.005%
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
6. PEP005 Topical Gel 0.01%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
7. PEP005 Topical Gel 0.015%
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
8. Vehicle Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 participants at risk
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 participants at risk
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 participants at risk
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 participants at risk
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 participants at risk
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 participants at risk
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 participants at risk
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 participants at risk
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.1%
1/32 • Number of events 1 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
General disorders
Death
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.0%
1/33 • Number of events 1 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.1%
1/32 • Number of events 1 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
Other adverse events
| Measure |
1. PEP005 Topical Gel 0.005%
n=32 participants at risk
Two days treatment day 1, 2
|
2. PEP005 Topical Gel 0.01%
n=34 participants at risk
Two days treatment, day 1, 2
|
3. PEP005 Topical Gel 0.015%
n=33 participants at risk
Two days treatment day 1, 2
|
4. Vehicle Gel
n=33 participants at risk
Two days treatment, day 1, 2
|
5. PEP005 Topical Gel 0.005%
n=33 participants at risk
Three days treatment, day 1, 2, 3
|
6. PEP005 Topical Gel 0.01%
n=34 participants at risk
Three days treatment, day 1, 2, 3
|
7. PEP005 Topical Gel 0.015%
n=32 participants at risk
Three days treatment, day 1, 2, 3
|
8. Vehicle Gel
n=33 participants at risk
Three days treatment, day 1, 2, 3
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
APPLICATION SITE IRRITATION
|
9.4%
3/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
8.8%
3/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
12.1%
4/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.0%
1/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
6.1%
2/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
8.8%
3/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
21.9%
7/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
General disorders
APPLICATION SITE PRURITUS
|
9.4%
3/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
8.8%
3/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
12.1%
4/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
14.7%
5/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.1%
1/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
General disorders
APPLICATION SITE DISCOMFORT
|
3.1%
1/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
2.9%
1/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
9.1%
3/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
6.2%
2/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
General disorders
APPLICATION SITE SWELLING
|
3.1%
1/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
9.4%
3/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
General disorders
APPLICATION SITE PAIN
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
9.4%
3/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
General disorders
APPLICATION SITE INFECTION
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
6.2%
2/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
2/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.0%
1/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.0%
1/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.1%
1/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
2.9%
1/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
6.2%
2/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.0%
1/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
6.2%
2/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
|
Nervous system disorders
HEADACHE
|
3.1%
1/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
6.1%
2/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
2.9%
1/34 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
3.1%
1/32 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
0.00%
0/33 • 57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor. As used herein, the term 'publish' shall include oral presentations, written abstracts, written manuscripts, etc.
- Publication restrictions are in place
Restriction type: OTHER