CompletedPhase 2

Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin

Australia24 participantsStarted 2010-10

Plain-language summary

This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.

Who can participate

Age range30 Years – 65 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.

Inclusion criteria

✓. Male and female patients aged 30 to 65 years.
✓. Female patients must be of either:
✓. Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
✓. Patient has agreed to allow photographs of the selected treatment area to be taken and used as part of the study data package.

Exclusion criteria

✕. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate) Gel.
✕. Current enrolment or participation in a clinical research study within 30 days of entry into this study.

What they're measuring

To evaluate the safety of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face.

Timeframe: Day 43

Trial details

NCT IDNCT01214577

SponsorPeplin

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01

View on ClinicalTrials.gov More Photo-damage trials