PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

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LEO Pharma

Status and phase

Completed
Phase 1

Conditions

Actinic Keratosis

Treatments

Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01387711
LP0041-02

Details and patient eligibility

About

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 histology.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female patients at least 18 years of age
  • Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
  • Patients with a 25 cm2 area of normal skin on the upper inner arm
  • Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
  • Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
  • Ability to follow study instructions and likely to complete all study requirements
  • Obtained written informed consent prior to any study-related procedures

Exclusion criteria

  • Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
  • 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, as determined by Investigator clinical judgment.
  • Anticipated need for in-patient hospitalisation or in-patient surgery during the study 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
  • Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
  • Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
  • Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
  • Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
  • Use of topical salves/topical steroids: within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
  • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers, systemic medications that suppress the immune system or UVB in the last 4 weeks
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas within 8 weeks prior to any screening visit
  • Use of systemic retinoids

Trial design

27 participants in 1 patient group

ingenol mebutate
Experimental group
Description:
PEP gel 0.05% once daily exposure
Treatment:
Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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