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)

Actinic Keratosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700063
• Other study ID #: PEP005-015
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2008
• Last updated: March 24, 2015
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: March 2015
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005 Topical Gel
0.005%, two days treatment
• PEP005 Topical Gel
0.01%, two days treatment
• PEP005 Topical Gel
0.015%, two days treatment
• Vehicle gel
two days treatment
• PEP005 Topical Gel
0.005%, three days treatment
• PEP005 Topical Gel
0.01%, three days treatment
• PEP005 Topical Gel
0.015%, three days treatment
• Vehicle gel
three days treatment

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Siller Medical	Brisbane	Queensland
Australia	Southderm Pty Ltd	Kogarah	New South Wales
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,	Austin	Texas
United States	Northwest Clinical Trial	Boise	Idaho
United States	Christie Clinic	Champaign	Illinois
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Burke Pharmaceutical Research	Hot Springs	Arizona
United States	Suzanne Bruce and Associates, The Center for Skin Research	Houston	Texas
United States	Dermatology Research of Arkansas	Little Rock	Arkansas
United States	Dermatology Research Associates	Los Angeles	California
United States	Koppel Dermatology	Los Angeles	California
United States	Dermatology Research Associates	Nashville	Tennessee
United States	TKL Research, Inc.	Paramus	New Jersey
United States	Philadelphia Institute of Dermatology	Philadelphia	Pennsylvania
United States	Oregon Medical Research Center	Portland	Oregon
United States	Integrated Research Group Inc	Riverside	California
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research	San Antonio	Texas
United States	Skin Surgery Medical Group Inc	San Diego	California
United States	470 Castro St Suite 202-204	San Francisco	California
United States	South Bend Clinic	South Bend	Indiana
United States	Spencer Derm and Skin Surgery Center	St Petersburg	Florida
United States	Dermatology Associates of Tyler	Tyler	Texas
United States	Solano Clinical Research	Vallejo	California
United States	Dermatology Specialists Inc	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs Recorded Throughout the Study	Incidence of AEs recorded throughout the study	57 days	Yes
Primary	Incidence of SAE Recorded Throughout the Study	Incidence of SAE recorded throughout the study	57 days	Yes
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.	Baseline	Yes
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.	Day 57	Yes
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.	Baseline	Yes
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)	Day 57	Yes
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)	Baseline	Yes
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)	Day 57	Yes
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)	Baseline	Yes
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).	Day 57	Yes
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	Day 57	Yes
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	57 days	No

External Links

•   Clinical Trials at LEO Pharma
•   Food and Drug Authority
•   Therapeutic Goods Administration