Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel

Completed · Phase 2

Conditions studied: Keratosis

In brief

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

Key facts

Study ID: NCT00239135
Run by: Peplin
People needed: 34
Starts: 2005-09-01
Expected to finish: 2005-12-01
Last updated by the study team: 2015-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Within four weeks prior to study entry, treatment with 5-flourouracil, imiquimod, masoprocol, or photodynamic therapy for lesion located anywhere on the body
Previous treatment with other immunomodulators (e.g vinblastine, podophyllin, colhamin, camptothecin), cytotoxic drugs (e;g cyclophosphamide, azathioprine, chlorambucil, nitrogen mustard, methotrexate), or interferon/interferon inducers (other than imiquimod)within four weeks prior to study entry
Previous treatment with psoralen plus UVA or use of UVB therapy within six months prior to study entry
Patients who require or desire excess or prolonged exposure to ultraviolet light(e.g sunlight, tanning beds) during the study
Use of medications that suppress the immune system within four weeks prior study entry (e.g cyclosporine, prednisone, methotrexate, alefacept, infliximab)
Within four weeks prior to study entry, use of topical retinoids or light chemical peels located within 10cm of the actinic keratosis lesion selected for treatment
Use of systemic retinoids (e.g isotretinoin, acitretin, bexarotene) within six months prior to study entry
Within four weeks prior to study entry, use of acid containing products (e.g salicylic acids or fruit acids such as alpha and beta hydroxy acids and glycolic acids). located within 10 cm of the actinic keratosis lesion selected for treatment
Anticipated need to use acid containing products on the treatment area during the study ( e.g salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids)
Concurrent disease that supresses the immune system(e.g HIV)

Where it is running

Dermatology Associates of Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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