NCT00432185

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 15, 2016

Status Verified

January 1, 2016

Enrollment Period

3.1 years

First QC Date

February 6, 2007

Last Update Submit

January 22, 2016

Conditions

Superficial Basal Cell Carcinoma

Keywords

sBCCTopicalDermatology

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.

    85 days

Secondary Outcomes (1)

  • Efficacy (complete sBCC clearance rate and composite sBCC clearance rate)

    85 days

Study Arms (2)

1

ACTIVE COMPARATOR

One day treatment

Drug: PEP005

2

ACTIVE COMPARATOR

Two day treatment

Drug: PEP005

Interventions

PEP005DRUG

0.25% PEP005 Gel

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Alta Dermatology

Mesa, Arizona, 85206, United States

Location

Dermatology Specialists Inc.

Oceanside, California, 92056, United States

Location

Skin Surgery Medical Group Inc.

San Diego, California, 92117, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

Advanced Dermatology and Cosmetic Surgery

Clermont, Florida, 34711, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Minnesota Clinical Studies Center

Fridley, Minnesota, 55421, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Rivergate Dermatology and Skin Care Center

Goodlettsville, Tennessee, 37072, United States

Location

Related Publications (2)

  • 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

    RESULT

  • 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 p.)

    RESULT

Related Links

MeSH Terms

Interventions

3-ingenyl angelate

Study Officials

  • Angela Smith

    Peplin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 7, 2007

Study Start

February 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 15, 2016

Record last verified: 2016-01

Locations

US(9)