Clinical trial: PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy (NCT01449513)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction