To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

Superficial Basal Cell Carcinoma Clinical Trial

Official title:

An Open-label, Multi-center, Dose-escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Given as Either a Single Application (on Day 1) or as Two Applications (on Day 1 and Day 8) to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432185
• Other study ID #: PEP005-009
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2007
• Last updated: January 22, 2016
• Start date: February 2007
• Est. completion date: March 2010

Study information

• Verified date: January 2016
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk

Description:

Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for many years in Australia as a "folk" remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Opeation Pty Ltd.

The proposed study follows a previously conducted 12 week study in sBCC, PEP005-003. This was a two dose schedule evaluating doses up to 0.05%. Histological clearance rate at the end of study was 71% for the 0.05% concentration on the Day 1, Day 2 schedule compared with 0% in the vehicle group.

The proposed study aims to determine the maximum tolerated dose level (MTD) of PEP005 Topical Gel, in patients, when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

1. Male or female patients at least 18 years of age.

2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass

3. Ability to follow study instructions and likely to complete all study requirements.

4. Written informed consent has been obtained.

5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Basal Cell
• Superficial Basal Cell Carcinoma

Intervention

Drug:
• PEP005
0.25% PEP005 Gel

Locations

Country	Name	City	State
United States	Advanced Dermatology and Cosmetic Surgery	Clermont	Florida
United States	Colorado Medical Research Center	Denver	Colorado
United States	Minnesota Clinical Studies Center	Fridley	Minnesota
United States	Rivergate Dermatology and Skin Care Center	Goodlettsville	Tennessee
United States	Alta Dermatology	Mesa	Arizona
United States	Dermatology Specialists Inc.	Oceanside	California
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Skin Surgery Medical Group Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gross K, Schmieder GJ, Tu J. Maximum Tolerated Dose and Safety of PEP005 (ingenol mebutate) Gel for Topical Treatment of Superficial Basal Cell Carcinoma. Summer Academy, American Academy of Dermatology meeting, Boston, MA, 2009. 2009: Poster no. 1902 (31

Gross K. Safety and efficacy of ingenol mebutate (PEP005) gel for topical treatment of superficial basal cell carcinoma. J Am Acad Dermatol 2009; 60(3, Suppl. 1): AB141; P2928

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.		85 days	Yes
Secondary	Efficacy (complete sBCC clearance rate and composite sBCC clearance rate)		85 days	No

External Links

•   Central IRB