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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
265
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
Incidence of AEs Recorded Throughout the Study
Incidence of AEs recorded throughout the study
Time frame: 57 days
Incidence of SAE Recorded Throughout the Study
Incidence of SAE recorded throughout the study
Time frame: 57 days
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
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
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
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)
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two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
three days treatment
Burke Pharmaceutical Research
Hot Springs, Arizona, United States
Dermatology Research of Arkansas
Little Rock, Arkansas, United States
Koppel Dermatology
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrated Research Group Inc
Riverside, California, United States
Skin Surgery Medical Group Inc
San Diego, California, United States
470 Castro St Suite 202-204
San Francisco, California, United States
Solano Clinical Research
Vallejo, California, United States
Dermatology Specialists Inc
Vista, California, United States
Spencer Derm and Skin Surgery Center
St. Petersburg, Florida, United States
...and 18 more locations
Time frame: Day 57
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
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
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
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
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
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