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NCT00659893 Clinical Trial

Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

Actinic Keratosis Clinical Trial

Official title:
A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00659893
Other study ID # PEP005-022
Secondary ID
Status Completed
Phase Phase 1
First received April 15, 2008
Last updated September 11, 2015
Start date April 2008
Est. completion date November 2008

Study information
Verified date November 2008
Source Peplin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be male and at least 18 years of age.

- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.

Exclusion Criteria:

- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).

- 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 within 2 cm of the selected treatment area(s).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PEP005 Topical gel
0.05%, two day dose

Locations
Country Name City State
Australia South East Dermatology, Belmont Specialist Centre Carina Heights, Brisbane Queensland
Australia Skin and Cancer Foundation Carlton, Melbourne Victoria
Australia St George Dematology and Skin and Cancer Centre Kogarah, Sydney New South Wales
Australia St John of God Dermatology Subiaco, Perth Western Australia
Australia Burswood Dermatology Victoria Park, Perth Western Australia
United States J&S Studies College Station Texas
United States Karen S. Harkaway, MD LLC Delran New Jersey
United States Medaphase Inc Newnan Georgia
United States Park Avenue Dermatology Orange Park Florida
United States Advanced Dermatology and Cosmetic Surgery Ormond Beach Florida
United States Radiant Research Inc. Pinellas Park Florida
United States Skin Surgery Medical Group Inc. San Diego California
United States Radiant Research Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Peplin

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability (incidence of AEs, SAEs and skin responses) Screening to End of Study (Day 57) Yes
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Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease Phase 3
Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
Terminated NCT01203878 - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy Phase 4
Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
Completed NCT00306800 - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Phase 3
Completed NCT00375739 - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses Phase 2
Completed NCT03285490 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Phase 3
Completed NCT03319251 - Biomarker Database Registry for Photodynamic Therapy
Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
Completed NCT02984072 - Menthol for PDT Pain Relief Phase 4
Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A

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