CompletedPhase 2

Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

United States200 participantsStarted 2006-09

Plain-language summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male patients at least 18 years of age.
✓. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
✓. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
✓. Screening laboratory values within the reference ranges as defined by the central 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 Use and Release of Health and Research Study Information has been obtained.
✓. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.

✕. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
✕. Location of the selected AK treatment area:
✕. anywhere on the face
✕. within 5 cm of an incompletely healed wound
✕. on the breast area of women
✕. on the dorsum of the hand
✕. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
✕. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.

Safety

NCT IDNCT00375739

SponsorPeplin

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-06

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male patients at least 18 years of age.
✓. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
✓. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
✓. Screening laboratory values within the reference ranges as defined by the central 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 Use and Release of Health and Research Study Information has been obtained.
✓. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.

✕. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
✕. Location of the selected AK treatment area:
✕. anywhere on the face
✕. within 5 cm of an incompletely healed wound
✕. on the breast area of women
✕. on the dorsum of the hand
✕. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
✕. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.