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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)

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00700063
Enrollment
265
Registered
2008-06-18
Start date
2008-06-30
Completion date
2008-10-31
Last updated
2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Peplin, Actinic keratosis, PEP005

Brief summary

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Interventions

DRUGPEP005 Topical Gel

0.005%, two days treatment

DRUGVehicle gel

two days treatment

Sponsors

Peplin
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Must be male or female * Female patients must be of * Non-childbearing potential; * Childbearing potential, provided negative pregnancy test and using effective contraception * 4 to 8 AK lesions on the face or scalp

Exclusion criteria

* Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area. * Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks. * Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of treatment area

Design outcomes

Primary

MeasureTime frameDescription
Complete Clearance Rate of AK Lesions;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
Incidence of AEs Recorded Throughout the Study57 daysIncidence of AEs recorded throughout the study
Incidence of SAE Recorded Throughout the Study57 daysIncidence of SAE recorded throughout the study
Incidence Rate and Severity of LSRs Following Study Medication ApplicationBaselineThe 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.
Incidence of Hyperpigmentation Following Study Medication ApplicationBaselineThe selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Incidence of Hypopigmentation Following Study Medication ApplicationBaselineThe 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)
Incidence of Scarring Following Study Medication ApplicationBaselineThe 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)

Secondary

MeasureTime frameDescription
Efficacy (Clearance of AK Lesions) Partial Clearance Rate57 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

Countries

Australia, United States

Participant flow

Recruitment details

First patient randomized: 24 June 2008 Last patient completed Day 57: 20 October 2008

Participants by arm

ArmCount
1. PEP005 Topical Gel 0.005%
Two days treatment day 1, 2
33
2. PEP005 Topical Gel 0.01%
Two days treatment, day 1, 2
34
3. PEP005 Topical Gel 0.015%
Two days treatment day 1, 2
33
4. Vehicle Gel
Two days treatment, day 1, 2
33
5. PEP005 Topical Gel 0.005%
Three days treatment, day 1, 2, 3
33
6. PEP005 Topical Gel 0.01%
Three days treatment, day 1, 2, 3
34
7. PEP005 Topical Gel 0.015%
Three days treatment, day 1, 2, 3
32
8. Vehicle Gel
Three days treatment, day 1, 2, 3
33
Total265

Baseline characteristics

Characteristic1. PEP005 Topical Gel 0.005%2. PEP005 Topical Gel 0.01%3. PEP005 Topical Gel 0.015%4. Vehicle Gel5. PEP005 Topical Gel 0.005%6. PEP005 Topical Gel 0.01%7. PEP005 Topical Gel 0.015%8. Vehicle GelTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
17 Participants21 Participants17 Participants15 Participants22 Participants21 Participants18 Participants22 Participants153 Participants
Age, Categorical
Between 18 and 65 years
16 Participants13 Participants16 Participants18 Participants11 Participants13 Participants14 Participants11 Participants112 Participants
Age, Continuous66.2 years
STANDARD_DEVIATION 10.2
67.5 years
STANDARD_DEVIATION 10.5
67.8 years
STANDARD_DEVIATION 7
65.2 years
STANDARD_DEVIATION 9.7
68.7 years
STANDARD_DEVIATION 11
67.7 years
STANDARD_DEVIATION 9
67.2 years
STANDARD_DEVIATION 10.1
69.3 years
STANDARD_DEVIATION 10.7
67.4 years
STANDARD_DEVIATION 9.8
Region of Enrollment
Australia
3 participants5 participants2 participants4 participants4 participants3 participants7 participants5 participants33 participants
Region of Enrollment
United States
30 participants29 participants31 participants29 participants29 participants31 participants25 participants28 participants232 participants
Sex: Female, Male
Female
3 Participants2 Participants1 Participants4 Participants6 Participants3 Participants4 Participants5 Participants28 Participants
Sex: Female, Male
Male
30 Participants32 Participants32 Participants29 Participants27 Participants31 Participants28 Participants28 Participants237 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
8 / 325 / 345 / 333 / 337 / 338 / 3412 / 320 / 33
serious
Total, serious adverse events
0 / 320 / 340 / 330 / 331 / 330 / 341 / 320 / 33

Outcome results

Primary

Complete Clearance Rate of AK Lesions;

Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area

Time frame: Day 57

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Complete Clearance Rate of AK Lesions;5 participants
2. PEP005 Topical Gel 0.01%Complete Clearance Rate of AK Lesions;10 participants
3. PEP005 Topical Gel 0.015%Complete Clearance Rate of AK Lesions;12 participants
4. Vehicle GelComplete Clearance Rate of AK Lesions;0 participants
5. PEP005 Topical Gel 0.005%Complete Clearance Rate of AK Lesions;11 participants
6. PEP005 Topical Gel 0.01%Complete Clearance Rate of AK Lesions;6 participants
7. PEP005 Topical Gel 0.015%Complete Clearance Rate of AK Lesions;16 participants
8. Vehicle GelComplete Clearance Rate of AK Lesions;3 participants
Primary

Incidence of AEs Recorded Throughout the Study

Incidence of AEs recorded throughout the study

Time frame: 57 days

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of AEs Recorded Throughout the Study12 participants
2. PEP005 Topical Gel 0.01%Incidence of AEs Recorded Throughout the Study12 participants
3. PEP005 Topical Gel 0.015%Incidence of AEs Recorded Throughout the Study8 participants
4. Vehicle GelIncidence of AEs Recorded Throughout the Study11 participants
5. PEP005 Topical Gel 0.005%Incidence of AEs Recorded Throughout the Study11 participants
6. PEP005 Topical Gel 0.01%Incidence of AEs Recorded Throughout the Study14 participants
7. PEP005 Topical Gel 0.015%Incidence of AEs Recorded Throughout the Study22 participants
8. Vehicle GelIncidence of AEs Recorded Throughout the Study6 participants
Primary

Incidence of Hyperpigmentation Following Study Medication Application

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)

Time frame: Day 57

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of Hyperpigmentation Following Study Medication Application13 participants
2. PEP005 Topical Gel 0.01%Incidence of Hyperpigmentation Following Study Medication Application13 participants
3. PEP005 Topical Gel 0.015%Incidence of Hyperpigmentation Following Study Medication Application7 participants
4. Vehicle GelIncidence of Hyperpigmentation Following Study Medication Application6 participants
5. PEP005 Topical Gel 0.005%Incidence of Hyperpigmentation Following Study Medication Application8 participants
6. PEP005 Topical Gel 0.01%Incidence of Hyperpigmentation Following Study Medication Application11 participants
7. PEP005 Topical Gel 0.015%Incidence of Hyperpigmentation Following Study Medication Application11 participants
8. Vehicle GelIncidence of Hyperpigmentation Following Study Medication Application15 participants
Primary

Incidence of Hyperpigmentation Following Study Medication Application

The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.

Time frame: Baseline

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of Hyperpigmentation Following Study Medication Application15 participants
2. PEP005 Topical Gel 0.01%Incidence of Hyperpigmentation Following Study Medication Application15 participants
3. PEP005 Topical Gel 0.015%Incidence of Hyperpigmentation Following Study Medication Application11 participants
4. Vehicle GelIncidence of Hyperpigmentation Following Study Medication Application8 participants
5. PEP005 Topical Gel 0.005%Incidence of Hyperpigmentation Following Study Medication Application13 participants
6. PEP005 Topical Gel 0.01%Incidence of Hyperpigmentation Following Study Medication Application12 participants
7. PEP005 Topical Gel 0.015%Incidence of Hyperpigmentation Following Study Medication Application15 participants
8. Vehicle GelIncidence of Hyperpigmentation Following Study Medication Application15 participants
Primary

Incidence of Hypopigmentation Following Study Medication Application

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)

Time frame: Day 57

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of Hypopigmentation Following Study Medication Application4 participants
2. PEP005 Topical Gel 0.01%Incidence of Hypopigmentation Following Study Medication Application6 participants
3. PEP005 Topical Gel 0.015%Incidence of Hypopigmentation Following Study Medication Application6 participants
4. Vehicle GelIncidence of Hypopigmentation Following Study Medication Application6 participants
5. PEP005 Topical Gel 0.005%Incidence of Hypopigmentation Following Study Medication Application9 participants
6. PEP005 Topical Gel 0.01%Incidence of Hypopigmentation Following Study Medication Application9 participants
7. PEP005 Topical Gel 0.015%Incidence of Hypopigmentation Following Study Medication Application12 participants
8. Vehicle GelIncidence of Hypopigmentation Following Study Medication Application6 participants
Primary

Incidence of Hypopigmentation Following Study Medication Application

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)

Time frame: Baseline

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of Hypopigmentation Following Study Medication Application7 participants
2. PEP005 Topical Gel 0.01%Incidence of Hypopigmentation Following Study Medication Application10 participants
3. PEP005 Topical Gel 0.015%Incidence of Hypopigmentation Following Study Medication Application6 participants
4. Vehicle GelIncidence of Hypopigmentation Following Study Medication Application8 participants
5. PEP005 Topical Gel 0.005%Incidence of Hypopigmentation Following Study Medication Application10 participants
6. PEP005 Topical Gel 0.01%Incidence of Hypopigmentation Following Study Medication Application9 participants
7. PEP005 Topical Gel 0.015%Incidence of Hypopigmentation Following Study Medication Application16 participants
8. Vehicle GelIncidence of Hypopigmentation Following Study Medication Application6 participants
Primary

Incidence of SAE Recorded Throughout the Study

Incidence of SAE recorded throughout the study

Time frame: 57 days

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of SAE Recorded Throughout the Study0 participants
2. PEP005 Topical Gel 0.01%Incidence of SAE Recorded Throughout the Study0 participants
3. PEP005 Topical Gel 0.015%Incidence of SAE Recorded Throughout the Study0 participants
4. Vehicle GelIncidence of SAE Recorded Throughout the Study0 participants
5. PEP005 Topical Gel 0.005%Incidence of SAE Recorded Throughout the Study1 participants
6. PEP005 Topical Gel 0.01%Incidence of SAE Recorded Throughout the Study0 participants
7. PEP005 Topical Gel 0.015%Incidence of SAE Recorded Throughout the Study1 participants
8. Vehicle GelIncidence of SAE Recorded Throughout the Study0 participants
Primary

Incidence of Scarring Following Study Medication Application

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)

Time frame: Baseline

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of Scarring Following Study Medication Application1 participants
2. PEP005 Topical Gel 0.01%Incidence of Scarring Following Study Medication Application3 participants
3. PEP005 Topical Gel 0.015%Incidence of Scarring Following Study Medication Application2 participants
4. Vehicle GelIncidence of Scarring Following Study Medication Application3 participants
5. PEP005 Topical Gel 0.005%Incidence of Scarring Following Study Medication Application6 participants
6. PEP005 Topical Gel 0.01%Incidence of Scarring Following Study Medication Application1 participants
7. PEP005 Topical Gel 0.015%Incidence of Scarring Following Study Medication Application10 participants
8. Vehicle GelIncidence of Scarring Following Study Medication Application3 participants
Primary

Incidence of Scarring Following Study Medication Application

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).

Time frame: Day 57

Population: 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.

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Incidence of Scarring Following Study Medication Application1 participants
2. PEP005 Topical Gel 0.01%Incidence of Scarring Following Study Medication Application1 participants
3. PEP005 Topical Gel 0.015%Incidence of Scarring Following Study Medication Application1 participants
4. Vehicle GelIncidence of Scarring Following Study Medication Application1 participants
5. PEP005 Topical Gel 0.005%Incidence of Scarring Following Study Medication Application5 participants
6. PEP005 Topical Gel 0.01%Incidence of Scarring Following Study Medication Application1 participants
7. PEP005 Topical Gel 0.015%Incidence of Scarring Following Study Medication Application5 participants
8. Vehicle GelIncidence of Scarring Following Study Medication Application2 participants
Primary

Incidence Rate and Severity of LSRs Following Study Medication Application

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.

Time frame: Day 57

Population: 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.

ArmMeasureValue (MEAN)Dispersion
1. PEP005 Topical Gel 0.005%Incidence Rate and Severity of LSRs Following Study Medication Application0.8 units on a scaleStandard Deviation 1.1
2. PEP005 Topical Gel 0.01%Incidence Rate and Severity of LSRs Following Study Medication Application1.1 units on a scaleStandard Deviation 1
3. PEP005 Topical Gel 0.015%Incidence Rate and Severity of LSRs Following Study Medication Application0.8 units on a scaleStandard Deviation 0.8
4. Vehicle GelIncidence Rate and Severity of LSRs Following Study Medication Application1.3 units on a scaleStandard Deviation 1.2
5. PEP005 Topical Gel 0.005%Incidence Rate and Severity of LSRs Following Study Medication Application1.4 units on a scaleStandard Deviation 1.4
6. PEP005 Topical Gel 0.01%Incidence Rate and Severity of LSRs Following Study Medication Application1.1 units on a scaleStandard Deviation 1
7. PEP005 Topical Gel 0.015%Incidence Rate and Severity of LSRs Following Study Medication Application0.8 units on a scaleStandard Deviation 1.3
8. Vehicle GelIncidence Rate and Severity of LSRs Following Study Medication Application1.1 units on a scaleStandard Deviation 0.9
Primary

Incidence Rate and Severity of LSRs Following Study Medication Application

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.

Time frame: Baseline

Population: 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.

ArmMeasureValue (MEAN)Dispersion
1. PEP005 Topical Gel 0.005%Incidence Rate and Severity of LSRs Following Study Medication Application1.4 scores on a scaleStandard Deviation 1.3
2. PEP005 Topical Gel 0.01%Incidence Rate and Severity of LSRs Following Study Medication Application1.6 scores on a scaleStandard Deviation 1.3
3. PEP005 Topical Gel 0.015%Incidence Rate and Severity of LSRs Following Study Medication Application1.3 scores on a scaleStandard Deviation 0.9
4. Vehicle GelIncidence Rate and Severity of LSRs Following Study Medication Application1.4 scores on a scaleStandard Deviation 1.1
5. PEP005 Topical Gel 0.005%Incidence Rate and Severity of LSRs Following Study Medication Application1.6 scores on a scaleStandard Deviation 1.5
6. PEP005 Topical Gel 0.01%Incidence Rate and Severity of LSRs Following Study Medication Application1.5 scores on a scaleStandard Deviation 1.3
7. PEP005 Topical Gel 0.015%Incidence Rate and Severity of LSRs Following Study Medication Application1.3 scores on a scaleStandard Deviation 1
8. Vehicle GelIncidence Rate and Severity of LSRs Following Study Medication Application1.7 scores on a scaleStandard Deviation 1.2
Secondary

Efficacy (Clearance of AK Lesions) Partial Clearance Rate

Partial 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

Time frame: 57 days

ArmMeasureValue (NUMBER)
1. PEP005 Topical Gel 0.005%Efficacy (Clearance of AK Lesions) Partial Clearance Rate11 participants
2. PEP005 Topical Gel 0.01%Efficacy (Clearance of AK Lesions) Partial Clearance Rate17 participants
3. PEP005 Topical Gel 0.015%Efficacy (Clearance of AK Lesions) Partial Clearance Rate17 participants
4. Vehicle GelEfficacy (Clearance of AK Lesions) Partial Clearance Rate3 participants
5. PEP005 Topical Gel 0.005%Efficacy (Clearance of AK Lesions) Partial Clearance Rate14 participants
6. PEP005 Topical Gel 0.01%Efficacy (Clearance of AK Lesions) Partial Clearance Rate9 participants
7. PEP005 Topical Gel 0.015%Efficacy (Clearance of AK Lesions) Partial Clearance Rate23 participants
8. Vehicle GelEfficacy (Clearance of AK Lesions) Partial Clearance Rate4 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026