NCT00329121

Brief Summary

The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's disease).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

3 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

May 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

May 22, 2006

Last Update Submit

January 16, 2015

Conditions

Carcinoma, Squamous Cell

Keywords

SCCISBowens diseasePEP005TopicalDermatologyCutaneous Squamous Cell Carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • Efficacy

Interventions

PEP005DRUG

Eligibility Criteria

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

You may qualify if:

  • Male patients, at least 18 years of age.
  • Post-menopausal female patients, at least 18 years of age, i.e. no menses for at least 12 consecutive months, or without a uterus.
  • A primary, clinically diagnosed and histologically confirmed SCCIS lesion with the histological diagnosis being made within 90 days of the screening visit.
  • Longest diameter of the SCCIS lesion between 5 mm and 20 mm.
  • Ability to follow study instructions and likely to complete all study requirements.
  • Written informed consent has been obtained.
  • Written consent for tissue from the biopsy of the histologically confirmed SCCIS lesion to be examined and stored by the central dermatopathologist has been obtained.
  • Agreement from the patient to allow photographs of the selected SCCIS treatment area (including the face) to be used as part of the study data package.

You may not qualify if:

  • Females of childbearing potential (a female is considered of childbearing potential unless she is post-menopausal, i.e. no menses for at least 12 consecutive months, or is without a uterus).
  • Location of the selected SCCIS lesion:
  • within 5 cm of an incompletely healed wound
  • within 2 cm of an eye, nose, or ear
  • within 1 cm of a scar
  • on the scalp, digits, lips, hands, feet, or ano-genital region
  • SCCIS lesions that have atypical clinical appearance, e.g. hypertrophic or hyperkeratotic or pigmented or ulcerated.
  • Histological evidence of nodular basal cell carcinoma (nBCC), superficial basal cell carcinoma (sBCC) or invasive squamous cell carcinoma (SCC) of the SCCIS in the biopsy sample.
  • Presence of suspected basal cell carcinoma (BCC) or invasive squamous cell carcinoma (SCC) within 2 cm of the selected SCCIS lesion.
  • Presence of known or suspected metastatic disease.
  • History or evidence of skin conditions other than SCCIS that would interfere with evaluation of the study medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
  • Known sensitivity to any of the ingredients in the study medication.
  • A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing)
  • of the selected SCCIS lesion at any time; or
  • within 2 cm of the selected SCCIS lesion during the 4 weeks prior to screening visit; or
  • +40 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southderm Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

Siller Medical

Brisbane, Queensland, 4000, Australia

Location

Related Publications (1)

  • Rosen R, Freeman M, Siller G, Zibert JR, Katsamas J, Knudsen KM, Spelman L. Ingenol mebutate 0.05% gel reduces cancer cells in squamous cell carcinoma in situ and shows marginal effect in seborrheic keratosis. JDDG J German Soc Dermatol 2013; 11(Suppl. 7): 22

    RESULT

MeSH Terms

Conditions

Carcinoma, Squamous CellBowen's Disease

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • Robert Rosen, Dr.

    Southderm Pty Ltd

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

AU(3)