CompletedPhase 2

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ

Australia24 participantsStarted 2006-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Safety

Trial details

NCT IDNCT00329121

SponsorPeplin

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12

View on ClinicalTrials.gov More Carcinoma, Squamous Cell trials