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

NCT ID: NCT01449513

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-05-31

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 reflectance confocal microscopy.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PEP005 Gel 0.05%

active ingredient of PEP005: Ingenol mebutate

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate

Intervention Type: DRUG

0.05% Ingenol mebutate Gel once daily for 2 consecutive days

Placebo Gel

Vehicle of PEP005 Gel

Group Type: PLACEBO_COMPARATOR

Placebo Gel

Intervention Type: DRUG

Gel vehicle of PEP005

Interventions

Ingenol mebutate

0.05% Ingenol mebutate Gel once daily for 2 consecutive days

Intervention Type: DRUG

Placebo Gel

Gel vehicle of PEP005

Intervention Type: DRUG

Other Intervention Names

PEP005

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects at least 18 years of age

2. Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on the upper extremity

3. Subjects must have a 25 cm2 area of normal skin on the inner upper arm

4. 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.

5. Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception

6. Ability to follow trial instructions and likely to complete all trial requirements

7. Obtained written informed consent prior to any trial-related procedures

Exclusion Criteria

1. 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)

2. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the investigational product

3. 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

4. Anticipated need for in-patient hospitalisation or in-patient surgery during the trial period.

5. Current participation in any other interventional clinical trial

6. Subjects who have received treatment with any non-marketed drug product within the last two months

7. Previous enrolment in this clinical trial

8. 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

9. 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

10. 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.

11. Use of systemic retinoids

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eggert Stockfleth, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Related Links

https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

LP0041-03

Identifier Type: -

Identifier Source: org_study_id