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:
Peplin
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00700063
First received: June 15, 2008
Last updated: August 24, 2012
Last verified: August 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700063
Show 28 Study Locations
Show 28 Study LocationsSponsors 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 24, 2012 |
| 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 May 23, 2013