Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

PEP005 Topical Gel

Vehicle gel

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.

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)

Incidence of AEs recorded throughout the study

Incidence of SAE recorded throughout the study

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.

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

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)

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)

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)

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).

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

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

Peplin

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.

1. PEP005 Topical Gel 0.005%

2. PEP005 Topical Gel 0.01%

3. PEP005 Topical Gel 0.015%

4. Vehicle Gel

5. PEP005 Topical Gel 0.005%

6. PEP005 Topical Gel 0.01%

7. PEP005 Topical Gel 0.015%

8. Vehicle Gel

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Australia

Region of Enrollment

Clinical Trial Disclosure Manager

Incidence of AEs Recorded Throughout the Study

Efficacy (Clearance of AK Lesions) Partial Clearance Rate

Incidence of SAE Recorded Throughout the Study

Incidence Rate and Severity of LSRs Following Study Medication Application

Incidence of Hyperpigmentation Following Study Medication Application

Incidence of Hypopigmentation Following Study Medication Application

Incidence of Scarring Following Study Medication Application

Complete Clearance Rate of AK Lesions;

Overall Study

Rare Diseases

Chiari Malformation Type 2

Cohort 1 One 25 cm2 treatment area; on one arm

Cohort 2 One 50cm2 contiguous treatment area; on one arm

Cohort 3 Two 25cm2 treatment areas; one on each arm

Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm

Cohort 5 One 75cm2 contiguous treatment area; on one arm

Cohort 6 Two 50cm2 contiguous treatment area; one on each arm

Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm

Cohort 8 One 100cm2 contiguous treatment area; on one arm

PEP005 Topical gel

George Schmieder, DO

Stephen Shumack, MD

Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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)	NCT00700063	Actinic Keratos...	PEP005 Topical ... PEP005 Topical ... PEP005 Topical ... Vehicle gel PEP005 Topical ... PEP005 Topical ... PEP005 Topical ... Vehicle gel	18 Years -	Peplin
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2	NCT00659893	Actinic Keratos...	PEP005 Topical ...	18 Years -	Peplin
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2	NCT00659893	Actinic Keratos...	PEP005 Topical ...	18 Years -	Peplin

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