Status:
COMPLETED
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
Lead Sponsor:
LEO Pharma
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01449513
Start Date
September 1 2011
End Date
May 1 2012
Last Update
March 7 2025
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117