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A Phase I, Two-stage, Single-centre, Open Label, Within- and Between-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Subjects With Actinic Keratosis on the Upper Extremity. A Single-arm First Stage Followed by a Two-arm, Parallel Group, Randomized, Placebo (Vehicle) -Controlled Second Stage.


Phase 1
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

A Phase I, Two-stage, Single-centre, Open Label, Within- and Between-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Subjects With Actinic Keratosis on the Upper Extremity. A Single-arm First Stage Followed by a Two-arm, Parallel Group, Randomized, Placebo (Vehicle) -Controlled Second Stage.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Degree of infiltration and necrosis of epidermis and dermis

Outcome Description:

Change in the degree of skin infiltration by inflammatory cells and degree of necrosis following treatment with PEP005 Gel, 0.05% as assessed by RCM.

Outcome Time Frame:

From baseline till day 57

Safety Issue:

No

Principal Investigator

Eggert Stockfleth, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

LP0041-03

NCT ID:

NCT01449513

Start Date:

September 2011

Completion Date:

June 2012

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

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