Expired Study
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Vista, California 92083


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.


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


Study is Available At:


Original ID:

PEP005-015


NCT ID:

NCT00700063


Secondary ID:


Study Acronym:


Brief Title:

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)


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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Peplin


Oversight Authority:

  • United States: Food and Drug Administration
  • Australia: Department of Health and Ageing Therapeutic Goods Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

8


Number of Groups:

0


Total Enrollment:

265


Enrollment Type:

Actual


Study Dates

Start Date:June 2008
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 6, 2014
First Received Date:June 15, 2008
First Results Date:June 13, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Incidence of AEs Recorded Throughout the Study
Time Frame:57 days
Safety Issues:True
Description:Incidence of AEs recorded throughout the study
Outcome Type:Primary Outcome
Measure:Incidence of SAE Recorded Throughout the Study
Time Frame:57 days
Safety Issues:True
Description:Incidence of SAE recorded throughout the study
Outcome Type:Primary Outcome
Measure:Incidence Rate and Severity of LSRs Following Study Medication Application
Time Frame:Baseline
Safety Issues:True
Description: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
Outcome Type:Primary Outcome
Measure:Incidence Rate and Severity of LSRs Following Study Medication Application
Time Frame:Day 57
Safety Issues:True
Description: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
Outcome Type:Primary Outcome
Measure:Incidence of Hyperpigmentation Following Study Medication Application
Time Frame:Baseline
Safety Issues:True
Description:The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Outcome Type:Primary Outcome
Measure:Incidence of Hyperpigmentation Following Study Medication Application
Time Frame:Day 57
Safety Issues:True
Description: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.
Outcome Type:Primary Outcome
Measure:Incidence of Hypopigmentation Following Study Medication Application
Time Frame:Baseline
Safety Issues:True
Description: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.
Outcome Type:Primary Outcome
Measure:Incidence of Hypopigmentation Following Study Medication Application
Time Frame:Day 57
Safety Issues:True
Description: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.
Outcome Type:Primary Outcome
Measure:Incidence of Scarring Following Study Medication Application
Time Frame:Baseline
Safety Issues:True
Description: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, pigmentati
Outcome Type:Primary Outcome
Measure:Incidence of Scarring Following Study Medication Application
Time Frame:Day 57
Safety Issues:True
Description: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, pigmentati
Outcome Type:Primary Outcome
Measure:Complete Clearance Rate of AK Lesions;
Time Frame:Day 57
Safety Issues:True
Description:Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Outcome Type:Secondary Outcome
Measure:Efficacy (Clearance of AK Lesions) Partial Clearance Rate
Time Frame:57 days
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:PEP005 Topical Gel
Description:0.005%, two days treatment
Arm Name:1
Intervention Type:Drug
Name:PEP005 Topical Gel
Description:0.01%, two days treatment
Arm Name:2
Intervention Type:Drug
Name:PEP005 Topical Gel
Description:0.015%, two days treatment
Arm Name:3
Intervention Type:Drug
Name:Vehicle gel
Description:two days treatment
Arm Name:4
Intervention Type:Drug
Name:PEP005 Topical Gel
Description:0.005%, three days treatment
Arm Name:5
Intervention Type:Drug
Name:PEP005 Topical Gel
Description:0.01%, three days treatment
Arm Name:6
Intervention Type:Drug
Name:PEP005 Topical Gel
Description:0.015%, three days treatment
Arm Name:7
Intervention Type:Drug
Name:Vehicle gel
Description:three days treatment
Arm Name:8

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Experimental
Arm Name:2
Study Arm Type:Experimental
Arm Name:3
Study Arm Type:Placebo Comparator
Arm Name:4
Study Arm Type:Experimental
Arm Name:5
Study Arm Type:Experimental
Arm Name:6
Study Arm Type:Experimental
Arm Name:7
Study Arm Type:Placebo Comparator
Arm Name:8

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Peplin

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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