PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

NCT01387711 | Completed Phase 1

• 1 other identifier: LP0041-02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 histology.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Leukocytes Infiltration and degree of necrosis of the AK lesion and skin

  Degree of skin infiltration of leukocytes and necrosis of the epidermis and dermis in the AK biopsies from Day 1, Day 2, and Day 3

  From baseline until day 3

Secondary Outcomes (1)

• Biological effects in the skin

  from baseline till day day 3

Study Arms (1)

ingenol mebutate

EXPERIMENTAL

PEP gel 0.05% once daily exposure

Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)

Interventions

PEP005 (Ingenol mebutat Gel, 0.05 %) DRUG

All eligible patients will receive PEP005 Gel, 0.05 %, on two consecutive days to both the AK Treatment Area and the Normal Skin Treatment Area

ingenol mebutate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, D-37075, Germany

Location

Related Publications (1)

• Emmert S, Haenssle HA, Zibert JR, Schon M, Hald A, Hansen MH, Litman T, Schon MP. Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate. PLoS One. 2016 Sep 9;11(9):e0160096. doi: 10.1371/journal.pone.0160096. eCollection 2016.

  PMID: 27612149 DERIVED

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael P Schön, MD

  Universitätsmedizin Göttingen, Georg-August-Universität

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 4, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 24, 2025

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)