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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00700063
First received: June 15, 2008
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: PEP005 Topical Gel
Drug: Vehicle gel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Peplin:

Primary Outcome Measures:
  • Incidence of AEs Recorded Throughout the Study [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
    Incidence of AEs recorded throughout the study

  • Incidence of SAE Recorded Throughout the Study [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
    Incidence of SAE recorded throughout the study

  • Incidence Rate and Severity of LSRs Following Study Medication Application [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]

    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.


  • Incidence Rate and Severity of LSRs Following Study Medication Application [ Time Frame: Day 57 ] [ Designated as safety issue: Yes ]

    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.


  • Incidence of Hyperpigmentation Following Study Medication Application [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    The 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 Hyperpigmentation Following Study Medication Application [ Time Frame: Day 57 ] [ Designated as safety issue: Yes ]
    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)

  • Incidence of Hypopigmentation Following Study Medication Application [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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)

  • Incidence of Hypopigmentation Following Study Medication Application [ Time Frame: Day 57 ] [ Designated as safety issue: Yes ]
    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)

  • Incidence of Scarring Following Study Medication Application [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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)

  • Incidence of Scarring Following Study Medication Application [ Time Frame: Day 57 ] [ Designated as safety issue: Yes ]
    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).

  • Complete Clearance Rate of AK Lesions; [ Time Frame: Day 57 ] [ Designated as safety issue: Yes ]
    Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area


Secondary Outcome Measures:
  • Efficacy (Clearance of AK Lesions) Partial Clearance Rate [ Time Frame: 57 days ] [ Designated as safety issue: No ]
    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


Enrollment: 265
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PEP005 Topical Gel
0.005%, two days treatment
Experimental: 2 Drug: PEP005 Topical Gel
0.01%, two days treatment
Experimental: 3 Drug: PEP005 Topical Gel
0.015%, two days treatment
Placebo Comparator: 4 Drug: Vehicle gel
two days treatment
Experimental: 5 Drug: PEP005 Topical Gel
0.005%, three days treatment
Experimental: 6 Drug: PEP005 Topical Gel
0.01%, three days treatment
Experimental: 7 Drug: PEP005 Topical Gel
0.015%, three days treatment
Placebo Comparator: 8 Drug: Vehicle gel
three days treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700063

  Show 28 Study Locations
Sponsors and Collaborators
Peplin
  More Information

Additional Information:
No publications provided

Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00700063     History of Changes
Other Study ID Numbers: PEP005-015
Study First Received: June 15, 2008
Results First Received: June 13, 2012
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:
Peplin
Actinic keratosis
PEP005

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014