Actinic Keratosis Clinical Trial
Clinical Evaluation:
Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the
FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial
Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on
day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical
research digital camera. Both subjects and investigators complete questionnaires at each
visit with individual questions regarding improvement in actinic keratoses and overall skin
appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each
characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest
quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators
will examine the subject's face and assign a numeric assessment on a 9 point scale ranging
from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A
second and third investigator will be presented at random blinded pretreatment (day 0) and
posttreatment (day 60) photographs of each subject and be asked to assign a numerical value
from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no
information regarding which day each photograph represents. Comparison will be made of skin
quality questionnaire scores from each visit and the pre and post treatment Griffiths'
Photonumeric Grades.
The investigator opted against a split-face study design given the difficulty of blinding
with this type of study as well as difficulty recruiting subjects willing to treat for two
separate courses.
Histologic Evaluation:
Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken.
Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A
digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies
will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken
immediately adjacent to previously photographed and identified pre-treatment biopsies.
Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post
treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and
overall epidermal and dermal thickness pre and post treatment will be compared.
n/a
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