Phase 1 N=24 Randomized Other

PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

Actinic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT01449513 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

May 2015

Primary outcome: Primary: Change in Degree of Infiltration — 1.42 percentage change

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Ingenol mebutate (Drug); Placebo Gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Infiltration	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—
PRIMARY Change in Degree of Necrosis	—	—

Summary

This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by reflectance confocal microscopy.

Eligibility Criteria

Inclusion Criteria

Male or female subjects at least 18 years of age
Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on the upper extremity
Subjects must have a 25 cm2 area of normal skin on the inner upper arm
Female subjects must be of either: • Non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or • Childbearing potential, with a confirmed negative urine pregnancy test prior to exposure.
Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
Ability to follow trial instructions and likely to complete all trial requirements
Obtained written informed consent prior to any trial-related procedures

Exclusion Criteria

Location of the selected treatment areas: • Within 5 cm of an incompletely healed wound or infected area of the skin • Within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma(SCC)
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the investigational product
Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety during the course of the trial, as determined by Investigator clinical judgment
Anticipated need for in-patient hospitalisation or in-patient surgery during the trial period.
Current participation in any other interventional clinical trial
Subjects who have received treatment with any non-marketed drug product within the last two months
Previous enrolment in this clinical trial
Prohibited Therapies and/or Medications 2 weeks prior to the Screening visit within 2 cm of selected treatment area:•Cosmetic or therapeutic procedures •Use of acid-containing therapeutic products • Use of topical salves or topical steroids
Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit: • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers,systemic medications that suppress the immune system, or with UVB
Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit: • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas.
Use of systemic retinoids

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01449513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.