NCT00239135

Brief Summary

The purpose of this study is :

  • To determine the maximum tolerated dose (MTD) for PEP005 Topical Gel in patients with actinic keratoses.
  • To evaluate patients for clinical safety
  • To determine the systemic absorption of PEP005 Topical Gel

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

October 12, 2005

Last Update Submit

March 24, 2015

Conditions

Keratosis

Keywords

Actinic KeratosisTopicalMaximum Tolerated DoseSolar KeratosisSun SpotsDermatology

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

Secondary Outcomes (2)

  • Safety and clinical efficacy

  • Systemic absorption

Interventions

PEP005DRUG

Eligibility Criteria

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

You may qualify if:

  • Male or Female at least 18 years of age
  • One AK lesion selected for treatment on the shoulders, chest, back or arms
  • Longest diameter of the selected lesion between 3mm and 15mm
  • Screening laboratory values within the references ranges as defined by the laboratory or "out of range" test results that are clinically acceptable to the Investigator
  • Ability to follow study instructions and likely to complete all study requirements
  • Written informed consent has been obtained
  • Written Authorization for the Use and Release of Health and Research Study Information has been obtained
  • Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.

You may not qualify if:

  • Females of child bearing potential (a female is considered to be of childbearing potential unless she is post-menopausal, i.e no menses for at least 12 consecutive months or is without a uterus)
  • Actinic Keratoses selected for treatment that are hypertrophic
  • Location of the selected actinic keratoses lesion:
  • within 5 cm of a scar
  • within 5 cm of any actinic keratosis lesion not selected for treatment
  • within 5 cm of an incompletely healed wound
  • on the breast
  • within 5 cm of an area previously treated with surgical excision
  • Presence of suspected basal cell carcinoma or squamous cell carcinoma within 5 cm of the selected treatment area
  • Presence of known or suspected metastatic disease
  • History or evidence of skin conditions other than AK which would interfere with the 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 liquid nitrogen, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) located within 10cm of the actinic keratosis lesion selected for treatment during three months prior to study entry or anticipated treatment within 10cm of the selected lesion during the study
  • Within four weeks prior to study entry, a cosmetic or therapeutic procedure located anywhere on the body
  • Within three months prior to the study entry, treatment with 5-flourouracil, imiquimod, diclofenac, masoprocol, or photodynamic therapy for lesions located within 10cm of the actinic keratosis lesion selected for treatment
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Associates of Tyler

Tyler, Texas, 75703, United States

Location

MeSH Terms

Conditions

KeratosisKeratosis, ActinicMelanosis

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPrecancerous ConditionsNeoplasmsHyperpigmentationPigmentation Disorders

Study Officials

  • Lawrence Anderson, MD, F.A.C.P

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

US(1)